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Laser Body Sculpting

SmartLipo-Trends in Use

by Panel Intelligence, LLC

April 2007

PROJECT OBJECTIVES

Panel Intelligence engaged a panel of experts to:

  • Understand the market potential of Cynosure (CYNO) product – Smartlipo™
    • Awareness of product
    • Dynamics of marketplace – current practices and expected trends
    • Strengths and weaknesses of product/procedure compared to
    • alternatives (e.g., Mentor’s UltraSculpt™)
    • Ideal patient population and dynamics of that population
    • Progress of launch in January and expected speed of uptake
    • Likely users – plastic surgeons and/or dermatologists and/or alternative markets [PCP, OB/GYN, ENT, Med Spa]
  • Gauge impact of CYNO rebranding efforts, completed sales management team, and bolstering of US direct sales force
  • Understand both the expected number of workstations placed and average utilization of disposables (fiber element)

companies and Products mentioned in this report

 

Company

Ticker Symbol

Product (s)

Cynosure

CYNO

Smartlipo™

Mentor Corp

mnt

UltraSculpt™

Sound Surgical Technologies

 

VASER® system; VAser liposelection® procedure

 

Key Findings

Trends: Typical body sculpturing patients are in their 20s to 50s.  There are no uniform trends in demand for liposuction other than localized increases in mesotherapy (St. Louis, New York City).  Panelists use surgical assisted (SAL), VASER (ultrasound assisted [UAL]), Microaire (power assisted [PAL]), and tumescent liposuction products.

Favorite products: Most commonly mentioned were VASER and Microaire.  Impressions of all options:

  • Lipodissolve: Panelists see this as an unproven therapy not supported by their society; some have heard or seen bad results and one expects a backlash against the technology once lackluster results are available
  • Impressions of Microaire: Impressions on PAL are mixed; some have had positive experiences while others have disliked using the equipment.  Great for all around liposuction.
  • Impressions of VASER: Works well in fibrous areas and for sculpting; can smoothly extract fat with less downtime.  On the downside, there is a risk of seromas and superficial burns at insertion sites.
  • Impressions of Smartlipo: Doctors are looking for more data.  The procedure is possibly less painful than SAL and may give better skin retractions.  Removing aspirate adds time and cost to the procedure and some have heard of problems with skin burns.  There is a high patient demand for this product; however, the cost of machine may prohibit uptake.

Ideal Smartlipo candidates: Small liposuctions (less than 200-300 cc per area) in localized areas or small redos and patients that are afraid of the operating room.

End users: Dermatologists already offering liposuction; high-volume liposuction practices or well-endowed hospitals with advertising dollars; not the PCP or med spa market because too expensive

inclusion criteria and Respondent demographics

Eleven plastic surgeons treating patients with liposuction and performing or at least interested in offering laser body sculpting to their patient populations.

Panelists

Name

Hospital affiliation

State

Panelist 1

Barnes West County Hospital

MO

Panelist 2

Private Practice

dc

Panelist 3

Swedish Medical Center

CO

Panelist 4

Plastic Surgery Specialists

IL

Panelist 5

Beth Israel Deaconess Medical Center

MA

Panelist 7

Manhattan Eye, Ear and Throat Hospital, St. Vincent

NY

Panelist 8

Stone Creek Plastic Surgery, Inc.

CA

Panelist 9

Del Mar Cosmetic Medical Center

CA

Panelist 10

Johns Hopkins Hospital

MD

Panelist 11

Ponte Vedra Plastic Surgery

FL

Panelist 12

DePasquale the Spa

NJ

 


Primary Question Index

Question

Page number(s)

Q1: Current marketplace dynamics

Please discuss the dynamics of the liposuction/body sculpting marketplace as you see it, including the following trends: • Patient candidates • Treatments provided • Products marketed to treat • Clinician type treating these patients

4

Click here for information on VASER and Mesosculpting --Please see Appendix A

4; 25

Q2: Current practices

How do you currently manage patients interested in liposuction/body sculpting? In your answer, please discuss what options you provide your patients, and if this differs by patient type. If you do not currently manage patients interested in liposuction/body sculpting, why not? What has prevented you from offering this service, and how interested are you in offering body sculpting to your patients and why?

6-9

Q3: Awareness of products on the market or in development

What liposuction/body sculpting manufacturers, if any, are you aware of and what is your perception of these companies? Who would you rank at the top of this market?

9-11

Q4: Strengths and weaknesses of current tools

What do you consider the greatest strengths and weaknesses of current products used in liposuction/body sculpting procedures today?

11-13

Click here to review product profile – Please see Appendix B

13; 27

Q5: Awareness of Smartlipo and perception

Prior to this discussion, had you heard of the Smartlipo system? If so, how did you become aware, and what was your perception of the system? Has that perception changed after reviewing the profile above? If so,how? If you were not aware of the Smartlipo system, what is your perception based on the profile above?

13-15

Click here to review several abstracts --Please see Appendix C

15; 29

Q6: Relative strengths and weaknesses

Compared to other systems designed for the liposuction/body sculpting marketplace, how does the Smartlipo system compare? Does this system offer any advantages over other systems you know? Is this system inferior in any way to other systems you are familiar with? Please explain.

16-20

Q7: : Ideal candidates

Who do you believe are good candidates for body sculpting treatment using the Smartlipo system? Does the Smartlipo system better serve any particular patient type?

20

Q8: : Likely end users

This is a panel of plastic surgeons. There is some discussion of body sculpting being performed in “alternative” markets, including primary care physicians, dermatologists, obstetrician/gynecologists, and med spas. Do you expect systems like the Smartlipo will penetrate these alternative markets or stay primarily in the plastic surgery field? Please explain.

20-21

Q9: Facilitators and barriers to adoption and use

What are the major facilitators and barriers to the uptake and use of the Smartlipo system?

21-22

Q10: Perception and/or experience with CYNO sales team

If you have any experiences with the Cynosure sales team, please discuss if the experience was positive or negative and why. What could a Cynosure sales representative do for you to increase the likelihood of use of the Smartlipo system?

22-23

Q11:  Other issues

Other than what has been discussed, what other issues, if any, are important in understanding the liposuction/body sculpting marketplace?

23-24


TRANSCRIPTS

LASER BODY SCULPTING

Informational - Please ReadIntroduction

Welcome to this discussion among plastic surgeons. Our primary goal in this discussion is to get your feedback on laser body sculpting, in particular the Smartlipo system. MedPanel discussions are enhanced when you, as a panelist, not only respond to the posted questions, but also reply to comments made by our moderator and your fellow panelists. We look forward to a lively and interactive discussion. Please note: In your participation on this panel, MedPanel expects and requires that you comply with the terms of the Consultant Confidentiality Agreement to which you previously agreed. If you have any questions about the terms of that agreement, please review them through the link provided on your MedPanel home page after you've logged in.

QuestionQ1: Current marketplace dynamics

Please discuss the dynamics of the liposuction/body sculpting marketplace as you see it, including the following trends: • Patient candidates • Treatments provided • Products marketed to treat • Clinician type treating these patients

Panelist 1: Typically our liposuction patients are in their 20's to 50's and are usually on the larger size (BMI >25). We are in St. Louis and have seen our liposuction patient volume decrease significantly due to Lipodissolve in the past 18 months (down by 70% prior to lipodissolve). The only patients left are the large patients. Lipodissolve is mostly administered by nurses/aestheticians under MD supervision (very loose supervision). Of those patients who get liposuction, some get SAL, some UAL, and some using PALs.

Panelist 11: Patients are interested in little or no downtime as evidenced by the interest in mesotherapy. Many patients believe that liposuction doesn't work ie "the fat goes elsewhere" On the other hand, many patients would prefer liposuction on the abdomen when abdominoplasty may be the procedure recommended by the plastic surgeon so a device that produces more predictable skin retraction is needed.

Panelist 12: My patients are generally in their late 20's to mid 50's. Mesotherapy has caught on in the NYC area to any great extent that I can tell. Most of my patients tend to be pretty athletic and frustrated that they can't exercise away their saddlebags, lovehandles or such. Another group is the double-chin population (late 30's to mid 50's) that isn't ready for a face or neck lift. With the external ultrasound or powerlipo techniques I offer, other than wearing a compression garment, I only ask that they avoid strenuous activity for 2 days. That's generally well accepted. Most procedures are done by plastic surgeons or dermatologists although there have been a few itinerants from south america that pass through periodically and leave carnage in their wake.

Panelist 3: Body sculpting is becoming a rapidly changing field from the perspective of technique. While the technology has changed very little (except for devices such as the VASER), our ability to achieve better results has. Liposuction has become an effective modality both on its own as well as an adjunct to other surgical procedures. In addition, the demand for other less invasive techniques has continued to rise.

Panelist 9: Liposuction still is consistently a popular request in my practice. I have used vaser for 5 years and with superficial techniques, obtain significant skin tightening.

Panelist 5: My practice is in the northeast and we have noticed a general decrease in cosmetic surgery with liposuction down a proportional amount. Our patient demographics have also changed with fewer younger patients. I don't see this as relating to the introduction of lipostabile but rather as a reflection of the economy in general and specific conditions in our area.

Panelist 7: there is a steady flow of patients for liposuction. cuurently using sal and powe assisted liposuction

Panelist 10: The patient demographic is quite broad. I get patients from early 20's all the way to the 60's. Of course, as they age, they are more often candidates for excisional procedures such as abdominoplasty, but they come for "liposuction". About 10% ask indepth questions like "do you use liposelection" "do you use tumescent technique". Almost all in the Balto-DC area are treated by plastic surgeons, but about 15% are treated by dermatologists and facial plastic surgeons/ENT. Some have friends that have had painful recovery or lumps, but many know someone with good results

Panelist 2: our practice dynamic is as most panelists, patients in the 20's to 50's and is pretty stable. we are in the dc metro area and have found that vaser is pretty popular but not widespread; any new technique that will enhance skin tightening would be welcome

Moderator - Please ReadFollow-up ALL: Increase in Mesosculpting and Vaser (UAL)

A few panelists note a decreasing interest in more traditional liposuction procedures, and an uptick in patient interest in mesotherapy and Vaser (UAL). Another panelist believes general economic conditions are more to blame for the decrease in liposuction demand. What do other panelists believe? Are others seeing a decrease in demand, and if so, to what do you attribute this trend? What trends are you seeing in liposuction versus less invasive sculpting techniques?

Panelist 12: I haven't seen any significant change in "demand" for liposuction. Patients inquire about mesotherapy since they see it in the media. At least in my patient population, most aren't ready for an unproven therapy.

Panelist 2: i havent seen a downturn in demand; dont recommend mesotherapy and most people dont ask about it, except the international clients;

Panelist 10: i agree with the other panelists -- I have not seen a decrease in demand--most of my practice is word of mouth and so people want what their friend had --which is liposuction. No one seriously inquires about mesotherapy--and if they do, I dismiss it in one sentence and the patients never return to that topic. They do ask about VASER or ultrasound in general. I think cosmetic surgery is refractory to most mild economic swings. Certain geographic regions are evergreen -- NY, DC, where as more suburban markets may be sensitive to macro-economic conditions. The housing market (>$500,000 is very elastic, but small purchases $5000-$7,000 do not show such sensitivity in my practice.

Panelist 1: The decrease in demand for us is directly related to lipodissolve.

Panelist 11: Patients have heard of mesotherapy and lipodissolve but it is difficult to determine if that has had a material effect on our liposuction practice which is stable. We have looked at and continue to be interested in the VASER system.

Panelist 7: i think there may be a decrease in demand for plastic surgeons who perform large liposuctions as patients seek supposedly less invasive and quick fixes. I think this is a trend in cosmetic surgery in general

Panelist 3: While there is definitely an increased interest in less invasive body contouring modalities, I don't feel that this has drmatically influenced the number of traditional body contouring procedures. In other words, I feel that the pie has grown and will continue to grow. Also, even though treatments such as mesotherapy are becoming more popular, I predict a backlash against this technology when the lackluster results become available.

Panelist 9: I have not had anyone ask about Lipodissolve. Vaser or liposelection still is requested by 25% of my patients. I have had 2 patients inquire about Smartlipo in the past 4 months. Liposuction body contouring still remains a high percentage of my surgical practice.

Panelist 5: as I said earlier, I attribute this primarily to economic conditions

Panelist 8: I haven't seen any decrease in demand for liposuction. A few patients do ask about mesotherapy or UAL after hearing about it in the media.

Supporting DocumentClick here for information on VASER and Mesosculpting --Please see Appendix A

Panelist 4: Panelist 4: Lipo is one of those procedures that is very prone to the latest “fad” Many of these “latest techniques” have been found to show little advantage and some occasional undesirable complications. I feel many plastic surgeons tend to latch onto these new techniques to attract more patients by being “cutting edge."

Panelist 2: i havent seen a downturn in demand just occasional market fluctuations; as for mesotherapy i dont recommend it and people dont tend to ask for it; everyone is treated individually so some need more sculpting and some need more generalized fat removal

Panelist 8: Our patients are mainly in their 30's to 50's. Patients generally are requesting more non-invasive techniques, incl mesotherapy, VASER, but tumescent liposuction and UAL are still recommended to many patients. A device or procedure that would help with skin tightening would be much welcomed, as considerable numbers of patients have skin laxity issues, requiring some type of abdominoplasty procedure. Loose thigh skin is another area that is often difficult to address. Plastic surgeons and dermatologists, and some ENT, are providing most of these procedures in our area.

QuestionQ2: Current practices

How do you currently manage patients interested in liposuction/body sculpting? In your answer, please discuss what options you provide your patients, and if this differs by patient type. If you do not currently manage patients interested in liposuction/body sculpting, why not? What has prevented you from offering this service, and how interested are you in offering body sculpting to your patients and why?

Panelist 1: Paitents with significant skin laxity usually start with a skin excision procedure (abdominoplasty or circumferential body lift). We frequently combine liposuction with these procedures. For those patients without skin laxity, we will perform liposuction. Mostly SAL, but for fibrous areas or redo's we will use the VASER (UAL). We have a microaire, but rarely use it. We've tried lipodissolve in our practice and Idon't think it works that well. For a significant number of large patient's (BMI >30), we will perform a debulking liposuction followed by a skin tightening procedure 4-6 months later.

Panelist 11: We see a significant number of patients interested in lip/body sculpting. Some of them are better candidates for abdominoplasty alone or in combinatation with liposuction. Others are poor candidates due to the relative degree of deformity i.e. a small amount of loose skin and minimal fat who don't want a mini-abdominoplasty scar.

Panelist 12: I don't treat the "big" ones with lipo, they get excisional surgery or perhaps go elsewhere. I've been very happy with the microaire device and generally find that the amount of swelling and bruising I see is comprable to that with external ultrasound but with less OR time. There does seem to be more skin contraction with XU so I use that in the face and on the bellies that are a tad loose. Otherwise, I go with the power lipo, particularly for smaller areas under local. Patients seem to tolerate it better. The only time I still use traditional lipo is if I'm planning to re-inject the fat, then I use the Tulip system.

Panelist 3: For my body contouring patients, I either use VASER LipoSelection alone or in combination with an excision procedure (e.g.: tummy tuck). I find that the VASER is extremely effective at creating a smooth contour and is definitely associated with a shorter healing time as compared to traditional liposuction. Given the fact that I am practicing in Denver, I find that my patients are extremely motivated and tend to be very athletic as well as versed on proper nutrition. This combination makes for a much smoother postoperative course overall.

Panelist 9: We use the vaser on every patient. With a large fat pad and abdominal skin laxity, the vaser liposuction for debulking, combined with the Avelar abdominoplasty technique has provided excellent results. I have avoided lipodisolve due to reports of irregular and unstifactory results.

Panelist 5: patients are seen in consultation, evaluated and treatment options given. If appropriate for lipo they may be done in our JCAHO certified Office OR or in the hospital depending on health criteria number of regions to be done and the total amounts of fat expected to be removed. I use ual, pal and old fashioned hand suction

Panelist 7: patient is either a candidate for liposuction or a candidate for excisional body contouring. Some are candidates for both. The patient needs to be educated to this and informed. Treat patients with sal/pal/excision. I do not use laser, smart lipo or lipodissolve

Panelist 10: Liposuction is a big draw--its the most popular easy-fix that patients seek. Once they come in, they may be more appropriate for alternate procedures, or will start to inquire about other procedures. Often, it is the "Gateway" procedure. They are usually pleased, and return to the practice over the future years. Most often, it is plain old liposuction. More male gynecomastia or repeat liposuction, I offer liposelection (my platform of choice for UAL). Almost all get PAL (easier on my arms/back). I have to dissuade patients who think this is an alternative to weight loss (about 5% of patients). Some just have to diet and hit the gym.

Panelist 2: my practice includes PAL (microaire), SAL and VASER and skin excision. i usually lipo contour with all tummy tucks and will often do other areas as well. i use the vaser on more challenging patients but not often.

Moderator - Please ReadFollow-up ALL: Experience with Lipodissolve

Panelists 1 and 9 indicate they are not satisfied or have heard reports of unsatisfactory results with Lipodissolve. What are others’ experiences with lipodissolve? Panelist 7, you mention you do not use laser, Smartlipo, or Lipodissolve. Why have you chosen not to use these approaches?

Panelist 12: I haven't heard of any satisfactory responses

Panelist 2: no experience with lipodissolve; have heard some promising anecdotes;

Panelist 10: I have no experience with lipodissolve and have not heard any significant anecdotes about it either. Now I'll have to go and google it.

Panelist 1: see my 1st response

Panelist 11: I have no experience with lipodissolve. I have had several patients mention that they were going to try it and have asked them to let me know whta they think Our society has been very specific in it's admonition against using lipodissolve so we are awaiting the results of the current studies.

Panelist 7: have used vaser which is more time consuming than sal or pal and there is no better result; smart lipo is too expensive and I have never been offered to try the machine; our literture states that the jury is not yet out on mesotherapy and the technology has not been perfected

Panelist 3: I think that the general consensus among most plastic surgeons is that results from mesotherapy are unproven and very disappointing. While it may have a role for very localized removal of fat, it will definitely not replace contouring of much larger areas.

Panelist 5: I have seen a couple of patients after lipodissole with unevenness and unhappiness.

Panelist 8: Have no experience with, nor have I heard any reports regarding lipodissolve.

Moderator - Please ReadFollow-up ALL: Microaire

Panelist 1 has but rarely uses Microaire (PAL); Panelist 12 has been very happy with Microaire because the amount of swelling is comparable to external ultrasound with less OR time, however external ultrasound is better for the face or skins that are loose because of the amount of skin contraction. Do others use Microaire? Please discuss why you use or do not use Microaire and your experiences.

Panelist 12: As another panelist noted, PAL is easier on the surgeon which is another plus given that the results are as good, or better, as with other methods I've tried.

Panelist 2: i use microaire more than any other modality; have been happy with sweling and/or skin retraction;

Panelist 10: I've been pleased w/ microaire. No untoward effects related specifically to that. will continue to use.

Panelist 1: see my 1st response

Panelist 11: We do not use microaire and currently are not interested due to mixed reviews. It is my impression that in Florida most plastic surgeons limit their liposuction to 4 L or less so fatigue is not that much of an issue.

Moderator - Please ReadFollow-up Panelist 11: Mixed reviews

You mention you are not interested in using Microaire because of mixed reviews it has received. What have been the negative reviews holding you back from using Microaire?

Panelist 11: Most practitioners with whom I have spoken have given it mixed reviews.

Panelist 12: I've had only positive experiences with PAL and with Microaire

Panelist 5: I too have had a great deal of success with micraire and PAL. It is in fact my instrument of choice for liposuction. My only complaint is that the gas powered handpiece in my hospital is very loud.

Panelist 1: None that I know of.

Panelist 1: None that I know of.

Panelist 11: Little or no increased efficacy over standard SAL.

Panelist 11: Little or no increased efficacy over standard SAL.

Panelist 3: I have actually used the PAL system and wasn't impressed. In addition to the fact that it really was hard on my wrist, I also didn't think that it offered any advantage over conventional liposuction. When compared to the VASER system, which is extremely easy to use, I definitely wouldn't recommend Microaire PAL...

Panelist 10: No problems with Microaire. I actually like it

Panelist 2: i like it

Panelist 9: I have tried it several times and felt the equipment was heavy, warm, and vibrated too much.

Panelist 8: None that I know of.

Panelist 7: I use microaire PAL almost exclusively as it is available at the hospital and make the surgery go quicker with less effort. i am able to acheive the same reult with sal

Panelist 3: I do not use Microaire and have been extremely pleased with the results of VASER for skin contraction.

Panelist 5: see below

Panelist 8: I do not use Microaire mainly due to mixed reviews.

Panelist 4: We use standard tumescent lipo with excellent results. We have a busy lipo practice with no significant complications. We rarely use VASER or microaire, though both are available.

Panelist 1: see my 1st response

Panelist 8: I try to screen out those who just need to lose weight first (5-10%) and suggest that they diet and hit the gym. I always determine whether they require skin excision, fat removal and/or both. I have been offering traditional tumescent liposuction and have now begun using VASER. I do not use lipodissolve.

Panelist 9: Vaser with a lower power superficial utilization, coupled with post op endermologie message, has given us safe and dramatic skin tightening results. While I have not used PAL, there should be no contraindication to it's use with vaser.

QuestionQ3: Awareness of products on the market or in development

What liposuction/body sculpting manufacturers, if any, are you aware of and what is your perception of these companies? Who would you rank at the top of this market?

Panelist 1: Well's Johnson: Standard SAL: Good, trustworthy company. Sound Surgical: VASER: Works well. Good Company. I don't like their "lease program." Microaire: PALs: Works well. Cost effective. Cyanosure: Smart lipo. No idea about this company.

Panelist 12: I've had only good experiences with Wells Johnson and with MicoAire. Can't speak to the others.

Panelist 3: The major players are Sound Surgical Technologies, Lysonix, and Mentor.

Panelist 9: Vaser (SST) good company although I do not like their lease program. Lysonix has caused major problems such as burns and seromas. Smartlipo from cynosure may have a role in superficial lipo and skin tightening, but the long term results are not available.

Panelist 5: Wells Johnson, Microaire, Byron, Tulip, Grams, all companies I have dealt with favorably. I really have no experience with Vaser nor Laser lipo

Panelist 7: use microaire PAL and coleman cannulas for AFG

Moderator - Please ReadFollow-up PANELIST 3 and 7

Panelist 3, you mention Sound Surgical, Lysonic, and Mentor. Please provide your perception of these companies. Panelist 7, you mention Micraire and Coleman. Please provide your perception of these companies.

Panelist 12: ...

Panelist 2: n/a

Panelist 1: see 1st response

Panelist 7: have had no problem with the companies that make these instruments and use them regularly

Panelist 3: I am very familiar with Sound Surgical since I live in Colorado. I feel that this technology is rapidly becoming the gold standard for body contouring and is associated with not only better results but also dramatically less downtime. I heard today the Mentor has essentially unloaded its ultrasonic liposuction recently.

Panelist 9: I concur

Panelist 11: Sound surgical and Mentor are both excellent and responsive companies.

Panelist 8: see 1st response

Panelist 11: Agree with responses from Panelists regarding liposuction companies. The only new technology we have considered is the VASER. The lease program has been the sticking point. I previously used the lysonix system for a period of 4 years and found it useful for backs, hips, redos, gynecomastia and male abdomen.

Panelist 10: VASER by liposlection has the best patient based name recognition, and increasingly with surgeons. Byron (part of Mentor now), Tulip are good. Microaire is good for PAL. Perception is that there is not much innovation/variety except by VASER.

Panelist 2: i like byron (mentor) for regular instruments; sound surgical for vaser, but i agree, i dont like their "lease" deal; and microaire for PAL. these are the "standards" i think

Moderator - Please ReadFollow-up ALL: Rank companies

Several companies where mentioned. From the list below, or from outside this list, please discuss which company you would rate as the market leader and why. a. Sound Surgical b. Microaire c. Wells Johnson d. Cynasure e. Mentor f. Lysonix g. Byron h. Tulip i. Grams

Panelist 12: In my experience Wells Johnson has reliable products and good customer service. The MicroAire PAL cannulas need refining of their attachment "buttons" which tend to come off.

Panelist 2: byron/mentor microaire sound surgical others

Panelist 10: Microaire Mentor Byron Tulip Sound surgical Wells Johnson Lysonix

Panelist 1: c,g,e,b,f,,a,h,d,i

Panelist 11: a. MentorByron b. Wells Johnson c. Sound Surgical Limited recent experience with the following d. Cynasure f. Lysonix h. Tulip i. Grams

Panelist 7: micro aire has been a leader in PAL and liposuction with safe effective equipment

Panelist 3: Sound Surgical is easily the leader because it has taken a very solid technology and essentially worked out the bugs.

Panelist 9: SST, Tulip, KMI, Byron, all the others

Panelist 5: Wells Johnson--they have been around a long time and are known for quality

Panelist 8: c,a,b.e - customer service

Moderator - Please ReadFollow-up ALL: Products

What specific products are your favorites and why?

Panelist 12: The electric PAL is much quieter than the older versions and more easily adjustable but still a bit bulky.

Panelist 2: byron's double canister suction machine is easy, powerful and holds a fair amount

Panelist 10: I have used a couple of PAL systems at various hospitals, and I like them all compared to standard lipo, but within them don't have any specific preferences.

Panelist 1: Wells Johnson is our workhorse and my favorite because it has almost universal application. If someone is fibrous, then I like the vaser.

Panelist 11: I liked the Vaser system, but I am in a group practice and all of us would need to be on board.

Panelist 7: PAL as noted above. Also Coleman system for AFG

Panelist 3: I really like the VASER.

Panelist 9: Vaser, rotating PAL device from KMI,Mangubat cannula from KMI

Panelist 5: microaire PAL

Panelist 8: VASER, have limited experience with PAL but do like it.

Panelist 4: I concur with Panelist 1 and have the same experience.

Panelist 8: Wells Johnson: Standard SAL - good company as far as I am aware Sound Surgical: VASER - also believe this to be a good company

Panelist 11: Sound surgical Mentor/byron Wells Johnson All exellent companies by reputation and our experience

QuestionQ4: Strengths and weaknesses of current tools

What do you consider the greatest strengths and weaknesses of current products used in liposuction/body sculpting procedures today?

Panelist 1: SAL is the workhorse of liposuction. Negatives are treating fibrous areas and the discomfort after liposuction. UAL Works well in fibrous areas. More postop pain and seromas. Still need to suck out what you've ultrasounded, which increases OR time and cost. PALs is good for fibrous areas. Additional disposable cost for each treatment. We perform all the above in the office for small procedures and in the OR for larger procedures (multiple areas or greater than 1000 cc).

Panelist 12: Power lipo has worked well for me, even in fibrous areas and for gynecomastia and for female breast reductions. I've never been impressed with internal ultrasound but have found external to help with skin contraction and to reduce p.o. swelling. (It also helps to treat p.o. swelling.) Never used laser lipo and don't know enough about it to know if its safety profile is something I'd be comfortable with. The limitation of the two I use is that they're time consuming and tiring when doing multiple/large areas.

Panelist 3: I currently use the VASER exclusively. I feel that its greatest strength is its ability to more smoothly extract fat with less downtime. In addition, the smaller cannulas make it easy to perform these procedures with much smaller and less noticeable incisions.

Panelist 9: Vaser used universally. Excellent contouring, skin tightening. Very goog in revision and fibrous cases. I have seen minor seromas and superficial burns at the insertion sites. Proceedure time is elongated.

Panelist 5: PAL: efficient but noisy UAL: excellent in tight difficult areas but PAL still needed

Panelist 7: lack of skin contraction is a big negative for many patients. time for infiltration and suction also is a negative. safety of pal and sal is a positive

Panelist 10: Greatest strengths is integrated easy to use UAL--especially by VASER. Downsides include screwing in ports to the skin. Cannula design/variety is limited, especially for working around curved surfaces and trying to minimize number of skin ports (esp. in ethnic patients whose scars tend to show more). VASER is great for sculpting, PAL (microaire) is great for general all-around liposuction. Less noisy, more "aesthetic" appearing and less industrial looking machines will have to be produced--much like IPL changed in the laser market.

Panelist 2: i use microaire most of the time, sal maybe 25% and vaser maybe 2-5%; because in my area there is one hospital and surgery center that have obtained the vaser and i dont do it in my office, i am somewhat limited in doing it.

Panelist 4: I have been very happy with SAL. I have not had the same positive experience with VASER as others. We have used Synergy on some post-op pts with good enhancement of our results.

Moderator - Please ReadFollow-up Panelist 4: Experience with Vaser

You mention your experience with Vaser is less positive than other panelists have had; please elaborate on your experience and what made it less than positive.

Panelist 12: I don't use or have experience with Vaser

Panelist 1: My experience with the vaser is fine.

Panelist 11: I have done only one case with VASER and I liked it. I was unable to convince my associates to proceed with the lease program.

Panelist 3: I have personally been very happy with the VASER system.

Panelist 10: VASER has been a very useful adjunct and marketing technique for my practice. it helps get better results easier.

Panelist 2: n/a for me

Panelist 8: Have personally been very happy with the VASER system.

Panelist 11: We have a busy four person practice and are generally pleased with SAL except for the usual rustrations associated with liposuction. Anything which offered and delivered more consistent fat removal and skin retraction would be considered for purchase.

Panelist 8: SAL: strengths are relative safety of the procedure and its effectiveness, negatives are its lack of skin contraction, time for infusion and suction, etc. UAL: better for fibrous areas, but time-consuming. Have not had much experience with lase lipo procedures.

Supporting DocumentClick here to review product profile – Please see Appendix B

QuestionQ5: Awareness of Smartlipo and perception

Prior to this discussion, had you heard of the Smartlipo system? If so, how did you become aware, and what was your perception of the system? Has that perception changed after reviewing the profile above? If so, how? If you were not aware of the Smartlipo system, what is your perception based on the profile above?

Panelist 1: I have heard of it from television. I am sceptical that it works as well as it is advertised. I'll wait until something is published in a peer reviewed journal before I jump on the bandwagon. What happens to the free fatty acids and triglycerides that are released after the fat cell ruptures? This sounds suspiciously like an expensive lipodissolve.

Panelist 12: I've seen ads but that's about it. The profile sounds like advertising hype to me.

Panelist 3: I became aware of this system when the question was posed by a local news reporter. Since then, I have heard a small amount of buzz about the technology but not much...

Panelist 9: Yes, I attended a less than academic presentation with short term results (<2 months). Blugerman in South America felt is was great marketing tool and useful for superficial fat and skin tightening, but needed to be combined with debulking lipo for best results.I do not feel that this equipment is worth 95K in USA when it can be acquired in Europe for 15K. Cynosure does not build the equipment, but only has American distribution rights, and is raping American doctors.

Moderator - Please ReadFollow-up ALL: Cost

Panelist 9 mentioned the Smartlipo system is available in Europe for $15,000. Is that an appropriate price for this system? What in your opinion is the value of this system?

Panelist 12: That would put in more inline with the cost of PAL or external ultrasonic liposuction

Panelist 5: It would have to be a good bit less to try it

Panelist 1: If that is true, then I definitely would not buy a Smartlipo machine. I would make a point to let at many people as possible know that they are being "screwed" by cyanosure. I really hope for cyanosure's sake this is not true. (Don't give me the song and dance that the additional $80,000 is to cover liability--I don't believe it)

Panelist 11: We were only quoted $300/use with a guaranteed or required mnimum number of uses, i.e. base monthly cost.

Panelist 3: That is much less expensive than I would expect. At that price, I would expect it to be very popular in the US (even if results were less than optimal).

Panelist 10: That really seems like an excellent price point designed to get great market penetration.

Panelist 2: seems high to me

Panelist 7: i do not know the price in europe. the value of the system depends on what it can and cannot accomplish. definitely much too expensive at this time

Panelist 9: I personally would be interested in a mimimal use rental arrangement vs. some pricing for purchase in the $20K range

Panelist 8: Seems like a reasonable and competetive price point, again, assuming it actually works.

Panelist 5: I was not aware of the system but it sounds very interesting. At that price I am not about to run out and buy or lease one for testing! Perhaps if it meets its promiss I will look into it.

Panelist 7: have heard of smart lipo. heard of problems with burns to skin also heard very expensive but high patient demand/interest

Panelist 10: Prior to this, had not really heard of SmartLipo, other than oblique refernces, and had never seen any details. After reviewing the profile, this seems very exciting. The cost does look prohibitive in terms of being able to recoop the ROI. The logic certainly seems sound (pending peer-reviewed scientific data about outcomes). Would be interesting to know if fat extraction is as efficient as UAL, or can these two things be combined?

Panelist 2: i am skeptical as well. this is getting quite a bit of press or ad campaigning but the copy seems a bit overzealous to me. a subcutaneous laser with minimal local? hmmm

Moderator - Please ReadFollow-up ALL: Experience with Vaser

Several of you mention your experiences with Vaser. Based on what you know about Vaser and Smartlipo, compare and contrast these two approaches to body sculpting. Panelist 1 asks what happens to the fatty acids and triglycerides that are released after the fat cells rupture. Is this an issue with using the Vaser, and if so, what happens in that case?

Panelist 12: I'm not one of the VASER or SmartLipo users

Panelist 2: i only have limited use of vaser and none of smartlipo; but i havent noticed a major issue with vaser and fat cell rupture issues or whatever

Panelist 10: VASER makes lipo look easy. I have no experience with Smartlipo but I dont think it will be as efficacious as VASER -- gut reaction, not based on science.

Panelist 1: They are aspirated by SAL after using the vaser.

Panelist 7: have used vaser with no better result and longer operative time have not used smart lipo

Panelist 3: I strictly use VASER for my body contouring procedures and have been extremely happy. I am not concerned with free TG's following fat cell lysis as I feel that most of products will be resorbed...

Panelist 9: Products from Vaser use will be aspirated.

Panelist 5: I believe that VASER treated areas are SALd just like internal UAL treated area thus removing released substances. I don't know about the SL system but I would be wary.

Panelist 11: The differences have been well discussed in the panel. The primary question is whether heat produced by the laser or ultrasonic energy produced by the VASER achieve a desired tissue response.

Panelist 8: I have just recently begun using VASER, no experience with SL. After VASER, fatty acids are removed using SAL. What happens to the fatty acids after SmartLipo is a good question.

Supporting DocumentClick here to review several abstracts --Please see Appendix C

Moderator - Please ReadFollow-up ALL: Clinical papers

After review of the clinical papers presented how, if at all, does this additional information lead you be more or less interested in Smartlipo? Assume that purchasing the machine is not an issue and you had access to the machine and discuss your interest in this offering for your patients.

Panelist 12: Clearly that depends on the results described in the papers. For example, if it's proven to be a fabulous and safe advance over other techniques, we'd all want to use it. If the results are spotty, or limited to certain areas or particular types of patients, I think we'd choose the patients accordingly.

Panelist 2: if peer review indicates a safe and effective modality and we can use/trial it at low or no cost then great! otherwise it will be like thermage, lots of hype but no game

Panelist 10: After clinical review, I would use the machine, but not purchase. If the hospital/ASC could be convinced to buy the machine, i would definitely want to try it since I'm often an early-adopter. I would pay a fee comparable to the VASER fee per use/surcharge. I would be reluctant however to sink $100k in a machine though--see all the reselling lasers on the market

Panelist 1: I want to see results in areas greater than 100cc. You can't pay off $95,000 just doing submental lipos or touchups. I want to see results in 1000cc love handles or 3000cc abdomens.

Panelist 7: these papers show no benefit to the procedure. would like to see a paper by a well know liposuction plastic surgeon

Panelist 3: It really doesn't change my mind.

Panelist 8: The clinical papers presented do not change my mind about Smartlipo. Assuming that purchasing the machine is not an issue, I would certainly use it and would be very interested to see the results for myself. I would not be nearly so eager if I had to sink $95,000 into it.

Panelist 9: I agree with all the panelists. Instead of taking huge profits, use some of this revenue to sponsor academic clinical trials!

Panelist 5: No more or less. I am concerned about the hepato-toxicity issue in theory but realistically, I doubt it would be a problem. I might be interested in trying the machine under the circumstances outlined in the question

Panelist 11: It may be a useful modality, but without any significant evidence i.e. the PRS paper to support superior efficacy, it would only be a novelty device or useful in marketing.

Panelist 4: I’ve only heard about it from ads. Again, in light of my previous experience with the “latest/greatest” lipo technique, I am very skeptical.

Panelist 11: I have read about it and numerous patients have mentioned it. Plus, we get several calls a week about "laser liposuction". It would have to offer dramatic results to justify the cost. Like many new technologies it appears to have been marketed to patients first and surgeons second.

Panelist 8: I have heard of Smart lipo through ad campaigns and some minimal discussion with others in my field. Major concern is whether it actually works and propensity for burns. Appears to be some patient demand.

Moderator - Please ReadFollow-up ALL: Additional Information

What additional information would you need to see to be comfortable using the Smartlipo system, assuming it was available to you?

Panelist 12: Studies published in a peer reviewed (reputable) journal that show that it's safe and that it actually does what the manufacturer claims

Panelist 5: longer term follow up

Panelist 1: I want to see the results from a large series of consecutive patients (at least 50). Not just the best 4 results that have been achieved.

Panelist 11: A greater number of patient results, i.e. good pre and post operative photographs and preferably side to side comparison as in the PRS paper.

Panelist 3: I would really need informaiton from trusted sources as to the real efficacy (both short and long-term) of this device. My feeling is that it may be good for very small areas but will not be very effective for larger contouring procedures.

Panelist 10: i concur w other panelists. Long term f/u and clinical outcomes (not just opinion-leaders trumpeting the latest thing).

Panelist 2: i agree with the other panelists

Panelist 2: i agree with the other panelists

Panelist 7: i woould like to see a clinical paper that shows good results and low complication rate; paper should be from a plastic surgeon with a large experience and well known in liposuction

Panelist 9: I strongly agree with the other panelists.

Panelist 8: I agree with the other panelists.

QuestionQ6: Relative strengths and weaknesses

Compared to other systems designed for the liposuction/body sculpting marketplace, how does the Smartlipo system compare? Does this system offer any advantages over other systems you know? Is this system inferior in any way to other systems you are familiar with? Please explain.

Panelist 1: Possibly may be less painful than standard SAL. May give better skin retraction, but this needsa to be proved. We perform a large amount of very large volume liposuctions (greater than 10 liters) and we get very impressive skin retraction from this. Not nearly as many people need skin tightening procedures as you would expect. If you need to suck out the aspirate, then tis increases the time/cost of the procedure (just like UAL).

Panelist 12: It would have to have some impressive clinical data to convince me to spend that amount of money on a new machine.

Panelist 3: I think that the system will prove very effective for smoothing small areas (e.g.: submentum/jowls) as well as being a good agent for touch-ups following conventional liposuction. I do not see how it could be as effective for larger volume fat extraction.

Panelist 9: Great marketing phrase and hype. May be useful in isolated areas such as neck and ant. axilla-sup. lateral breast. Can not be used alone on large or medium adiposities. Has an expensive fiber replacement cost. Significantly increases OR time.

Moderator - Please ReadFollow-up ALL: Fiber replacement cost

Panelist 9 mentions Smartlipo has an expensive fiber replacement cost. Assuming it costs $50 per use, given the overall cost and the average number of uses, is this fiber cost reasonable or unreasonable? How does it compare to other disposables you regularly use?

Panelist 12: For liposuction, that's rather expensive. I'd call in unreasonable in the context of a $100,000 machine of unproven value.

Panelist 2: i think thats high. microaire, etc is basically only cost of cleaning and occasional replacement and maintenance; regular sal no cost for a long time other than cleaning; so it could be lower

Panelist 10: i think a $50 cost is negligible.

Panelist 1: For a $95,000 piece of equipment, I don't expect to have a disposable cost. So even though it is a relatively small number, I don't like it and would be less likely to purchase a smartlipo unit.

Panelist 7: cost seems more than what I use now

Panelist 3: I have no disposable costs associated with the VASER but I do have a per use charge of $250 that is charged to me by the facility. I just bundle that in with the overall costs and have not had a problem.

Panelist 8: Although a disposable cost of $50 per use is not necessarily unreasonable, it would be a deterrent for me in purchasing a $95,000 machine. In comparison, no disposable cost for VASER and negligible cost for UAL.

Panelist 9: The cost of replacement of the fiber is $500. The fiber can break easly at any time. This is not a good selling point.

Panelist 5: I wouldn't mind this cost if the machine could be used frequently with good and predictable results.

Panelist 11: At $50, the fiber replacement cost is not an issue, the larger issue is the high cost of the system.

Panelist 5: Looks impressive on paper but it had better meet all the hype to be worth the investment.

Panelist 7: much more expensive than other systems. has theoretical advantage of skin retraction. problems can be laser burns and lack of control

Panelist 10: The price point seems high and would impede me from buying this. The word "Laser" is a great attractant for patients-rightly or wrongly. Pretty device, but does it work--the data/quality will be the key.

Panelist 2: worry about the real results in larger volumes other than very small fine-touch areas; cost prohibitive; not well-tested; public hears laser lipo and thinks wow; i spend more time deflecting bs questions than talking about the stuff that works

Moderator - Please ReadFollow-up ALL: Small areas and touch ups

Panelist 3 believes Smartlipo may prove effective for smoothing small areas and for touch-ups following conventional liposuction, but less likely successful in large volume fat extraction. a) Do you agree with this hypothesis b) What is your estimate of how many patients you personally see in a typical month that are candidates for small area smoothing or touch-ups following liposuction?

Panelist 12: That's where the clinical studies are needed. Touch ups under local are fairly common but not so common as to justify the expense of new machine. Small areas already do well with small cannulas and current techinques. It's the skin tightening aspect for these areas that, if proven, could set SmartLipo apart from the others.

Panelist 2: i agree that this may be the case; but again somewhat unproven; i see a moderate amount of folks that could use small area touch ups and refinement

Panelist 10: in my practice the number seeing small touchups is not significant. About 5-10% of my own post-ops may want that, but I try to contain costs on touch ups and do those under local. I would not want to ratchet that cost up. Off-the-street small spot lipos are rare. Hypothesis: I think smartlipo would be more broadly applicable including large volume lipo.

Panelist 1: A. Yes B. 5-10% of patients that have had lipo. (1-2 per month)

Panelist 7: I agree that it is not useful for large cases but question what the benefit would be even in a small or revision case

Panelist 3: I'll respond to my own response... I obviously agree; however, I am not seeing a large number of patients who need either touch-ups or who wouold benefit from very localized fat extraction. I'll also tell you that I am currently at the ASAPS convention in New York and that the buzz about SmartLipo is overall negative. Most people feel that this is hyped and will not be able to deliver results.

Moderator - Please ReadFollow-up ALL: ASAPS Convention

Panelist 3 mentions the buzz about SmartLipo overall is negative at the current American Society for Aesthetic Plastic Surgeons convention in New York. Panelist 3, can you elaborate on the negative buzz of this product’s results not likely living up to its hype? What is the source of the buzz? Other panelists, have you recently heard negative buzz regarding SmartLipo (that you have not already mentioned in this forum)?

Panelist 12: I didn't hear much of anything either way at the ASAPS meeting

Panelist 5: I just returned from ASAPS and heard mixed reviews on SL The mixed reviews seemed to come from several camps. There were those who had seen demonstrations and felt that the technique was very exciting and efficacious. I did not talk to any ASAPS members with direct experience. Others wondered whether the technique would be predictable and/or useful for anything other than very small areas or small touch ups. The feeling was that the equipment would be very expensive for such a narrow use. My own reservations are in tune with this. Would I want to spend that much money for equipment which would only be useful in a small number of my liposuction cases as opposed to lipo equipment that could be used in virtually all my cases. I did not talk to any company reps about this.

Panelist 1: I haven't heard anything, but it's much more important to have good scientific data, photos, and reproducibility than to have a catchy name and marketing. Refer back to lipodissolve for another product that didn't live up to it's hype.

Panelist 11: No negative buzz, just a fair amount of legitimate skepticism.

Panelist 3: The negative buzz that I heard was from a number of other Plastic Surgeons who have either tried it themselves or have friends who have performed procedures with the device. The general feeling is that it is a lot of hype and very little substance.

Panelist 10: I did not hear anything about it. that alone is negative, i guess.

Panelist 2: not yet

Panelist 7: i have heard negative buzz in the operatibg room amongst plastic surgeons regarding smart lipo - complications, efficacy, etc

Panelist 9: I did not attend the ASAPS this year.

Panelist 11: I did not attend the ASAPS mtg this year due to a conflict. I did have 2 associates who attended the meeting and who did convey any real interest in the technology, i.e. nothing at the meeting convinced them to take an interest.

Panelist 8: I did not attend the ASAPS meeting this year.

Panelist 8: a) yes, I agree. b) 2-3 patients per month (no more than 10% or all liposuction patients)

Panelist 9: Since the number of pulses are defined (limited) by the company, use in large adiposities would not be possible. Small area lipo patients nimber 1 or 2 per month. Lax skin patients number 3-4/momth.

Panelist 5: I do agree and I see one or two patients like this in a month most of whom don't get any touch ups because of the limits of what can be done

Panelist 5: I agree I see 1 or 2 like this a month most of whom do not opt for touch ups as the areas are too small or insignificant to justify treatment and recovery

Panelist 11: I'm not clear how he reached his hypothesis except with respect to the time involved with larger volume procedures. We generally see a relatively small number of patients, 3-4/month/surgeon who may need small volume or touch up liposuction.

Panelist 4: I concur with Panelist 12. I’d like to see some real data.

Panelist 8: An obvious down-side is its expense compared to other systems as well as possibility of burns as a complication. A major plus would be its ability to produce skin retraction.

Panelist 11: Smartlipo uses an "internal" laser to produce lipolysis and tissue heating. If this leads to improved fat removal and skin retraction then it would offer an advantage over standard SAL and perhaps approximate the VASER.

QuestionQ7: Ideal candidates

Who do you believe are good candidates for body sculpting treatment using the Smartlipo system? Does the Smartlipo system better serve any particular patient type?

Panelist 1: I guess the ideal candidate would be a small liposuction (less than 200-300 cc per area). Probably good for those patients who are afraid of the OR.

Panelist 12: If you're really getting skin tightening, I'd really like to see some evidence of it before I'd try it on the "flaccid" patients mentioned in the profile. In particular I'd like to see that the contraction is smooth and even. I can easily envision it creating lots of dimples and contour irregularities that would be hard to treat.

Panelist 3: I feel that persons with small areas of localized fat would be good candidates for this procedure. Again, I do not see this as being a good technology for larger volume extractions.

Panelist 9: Localized areas(i.e. neck) or small lipo cases. Perhaps small redo's.

Panelist 5: Patient's with small areas and borderline skintone if it really does what they say it does

Panelist 7: would think ideal candidate is one with small area of fat needing removal and could benefir from skin retraction

Panelist 10: To me it seems the question should be the other way around. "Who is not a candidate?" If it is a good technology that improves results, everyone should get it. I may want to limit it in sensitive areas such as face/neck until I'm much further on the learning curve with the device.

Panelist 2: patients with small easily accessible in the office areas; not for >500cc aspirates i imagine;

Panelist 4: I agree. This seems like a small area technique.

Panelist 8: Agree that it might work best on small area liposuction cases especially where some skin retraction would be beneficial, but patients with moderate or somewhat larger areas of fat might be candidates as well if they desire a less invasive technique - and assuming it actually works.

Panelist 11: Patients who may not be good candidates for standard SAL due to skin laxity. Perhaps patients with large localized fat deposits, i.e. liposuction will produce significant laxity.

QuestionQ8: Likely end users

This is a panel of plastic surgeons. There is some discussion of body sculpting being performed in “alternative” markets, including primary care physicians, dermatologists, obstetrician/gynecologists, and med spas. Do you expect systems like the Smartlipo will penetrate these alternative markets or stay primarily in the plastic surgery field? Please explain.

Panelist 1: Probably the dermatologists who already perform liposuction will be interested. The cost to entry is probably too high for the pcp's, med spas, and anyone who doesn't perform a significant amount of lipo. That's why lipodissolve has such great penetration (there is very low cost to entry).

Panelist 12: Unless and until it's proven to be a major advance, only those with very high volumes, very well endowed hospitals and/or good ad and pr campaigns are likely to be early adopters.

Panelist 3: This device will definitely find its way into the non-PS environment and this is where my worries lie. I am greatly concerned that these people will overmarket and overpromise results and essentially force a more aggresive utliziation of the device with a resultingly higher complication rate.

Panelist 9: Ob-Gyn docs are using this device as a way to bypass abdominoplasties. PCP's may feel the device is too costly. Until we hear about wonderful results from multiple surgeons with 6 + months experience and a lack of complications, the early promoting of this equipment may come back to haunt Cynosure.

Panelist 5: if there is money to be made then I am sure others will get into the act. Public beware.

Panelist 7: in my large east coast city it is primarily used by dermatologists and I expect that it will remain that way and plastic surgeons will continue to do large body contouring with conventional techniques

Panelist 2: i agree that the cost will limit the peripheral "cosmetic" types but imagine it will invade the others

Panelist 4: I doubt it will be board-certified plastic surgeons, except for those who need a new marketing pearl. I’m not too impressed. Again the “alternative markets” might grab at this technique, which may well be its death knell, because of higher complications as well as a “delegitimizing” of the company and the poduct.

Panelist 10: I do think alternate users will try to adopt, but if they are struggling PCP's and gynecologists trying to add a buck to their practice, they are not going to sink $100k into this to try it.

Panelist 8: I agree that cost will be a barrier to some, but if there is money to be made, I believe Smartlipo will penetrate the alternative markets sooner rather than later.

Panelist 11: That would depend on the volume of their liposuction practices and their financial resources.

QuestionQ9: Facilitators and barriers to adoption and use

What are the major facilitators and barriers to the uptake and use of the Smartlipo system?

Panelist 1: Barriers : Cost and prove it works better than SAL (less pain, swelling, bruising). Facilitators : It's the "new, sexy gizmo of the moment." Everyone is looking for the easy way to lose weight/fat.

Panelist 12: You can probably get a good deal of PR exposure by being one of the first to offer it. It's cost will be a big drawback for those in private practice.

Panelist 3: The biggest barrier will be the cost of the device. If the results do prove good, however, there will probably be a waiting list of clients since the trend is moving towards less invasive technologies.

Panelist 9: Barriors: cost and overhype Facilitators: respected clinicians who have academically evaluated this device

Panelist 5: Barrier: Cost and lack of clinical evidence that it really does what they say Facilitator: marketed as the newest, less invasive, "In Thing" for lipo

Panelist 7: COST RISK of injury

Panelist 10: Barriers include: requirement for special training, and of course, cost. It is significantly higher than similar competitors. VASER has a different revenue model -- pay per use, but I don't know how successful that is. Facilitators will include company based marketing and marketing of its users,supporting its physicians. Direct-to-consumer adverts by the manufacturer will help. Glam-factor will help. Outcomes data will be CRUCIAL.

Panelist 2: barriers are obviously the cost and potential learning curve. it would be nice to see/attend demonstrations or training of some kind; facilitators would be if the hype is real and that the public is saavy about new trends and techniques

Panelist 4: Cost. Bad taste from previous “over-hyped” products.

Panelist 8: barriers: cost of the system, learning curve to avoid complications, proof that it really works as good or better than current modalities facilitators: trend toward less invasive procedures and patient demand for same

Panelist 11: Facilitators would include peer reviewed articles and/or presentations demonstrating a distint advantage of the system Barrier is principally cost.

QuestionQ10: Perception and/or experience with CYNO sales team

If you have any experiences with the Cynosure sales team, please discuss if the experience was positive or negative and why. What could a Cynosure sales representative do for you to increase the likelihood of use of the Smartlipo system?

Panelist 1: No exposure. I would like to see peer reviewed journal articles. Let us use a machine for 2-4 weeks to evaluate how well we think it works. I don't care if some "well respected physician" endorses the product, because I have seen several products that were endorsed that didn't turn out to be quite that effective (thermage anyone?)

Panelist 12: As panelist 1 mentioned, Thermage is the latest/greatest of recent bad ideas that comes to mind. I would also like to see legitimate clinical evidence that it does what they claim and doesn't have the downside potential I envision for it. Given that, a hands on trial on patients in my own practice setting would be the next step before I'd consider adopting it.

Panelist 12: As panelist 1 mentioned, Thermage is the latest/greatest of recent bad ideas that comes to mind. I would also like to see legitimate clinical evidence that it does what they claim and doesn't have the downside potential I envision for it. Given that, a hands on trial on patients in my own practice setting would be the next step before I'd consider adopting it.

Panelist 3: I would be more likely to use the system if I was able to trial it for a few weeks and actually see if the results match up to the hype.

Panelist 9: I agree with the other panelists. So far the company rep. has told me they will not let us utilize the equipment in our office, and has been arrogant about how this will overwhelm all other lipo treatment. I am aware of certain price concessions given to prominent users as a consession for marketing their name as a "USER".

Panelist 5: I have never met a company rep. If I did I would ask for training and a way to "test drive" a unit

Panelist 7: no experience. let us try the machine for free

Panelist 10: I have not had any experience with the Cyno sales team. A face-to-face dramatically improves the odds of actual purchase.

Panelist 2: no interaction with the reps or company; not sure who in my immediate area is using it; would need a hands-on trial at no cost to feel comfortable; claims dont mean anything unless its either peer-reviewed or trusted colleagues can give you the truth; i agree that thermage is not what it was hyped to be and havent adopted it for that reason;

Panelist 4: No exposure. I always want to trial any product before I buy it.

Panelist 8: No experience with the Cynosure sales team. Agree completely with other panelists in wanting to try the product for free for a few weeks at no cost to determine how well it does or does not work. Also would like to see some peer reviewed journals on the Smartlipo system and a face-to-face meeting with a sales rep.

Panelist 11: no experience with cynosure a demonstration use is the best way to investigate the device

QuestionQ11: Other issues

Other than what has been discussed, what other issues, if any, are important in understanding the liposuction/body sculpting marketplace?

Panelist 1: That pretty well covers it for me.

Panelist 12: Patients do want a quick recovery and many have heard (probably true) horror stories about painful procedures and lousy results. I think the company would be very wise to limit it's use to experienced surgeons until it has proven itself. (I still think they should limit it after that too but realize that in the real world there's a much bigger market of pseudo-plastic surgeons than those of us who are actually trained in the speciality.)

Panelist 3: I think the biggest issue would be who would be performing the procedures. I see this as falling into the hands of very unexperienced practitioners (and even non-physicians). When this happens, the complication rate will certainly rise accordingly.

Panelist 9: If this device is safe and effective for skin tightening, without complications, it could be utilized by all M.D.s in an office setting. These are big IF's. Remember Thermage.

Panelist 5: One must understand the economics of lipo. It is centered on a younger less affluent population base which is greatly affected by the economy and economic factors. Therefore lipo must remain cost effective. A new expensive machine may be OK on Park Ave or Rodeo DR but may not be able to compete with PAL, UAL in other marketplaces on a cost basis

Panelist 7: patients tend to show interest in the newest techniques but we have to make sure they are safe and effective before offering to our patients

Panelist 10: Patient safety is the zeitgeist now in plastic surgery. Is the device reliable/effective/efficacious/safe ? Ease of use and patient safety must be achieved, and if achieved, must be emphasized.

Panelist 2: i agree with the other panelists; the "latest-greatest" needs to be reliable and safe and not over utilized by less than experienced MD's

Panelist 4: Nothing else to add

Panelist 8: Agree with carefully examining safety and effectiveness issues.

Panelist 8: Agree with carefully examining safety and effectiveness issues.

Panelist 11: Results, results, results. There are many urban myths surrounding liposuction, i.e. the fat goes elsewhere or liposuction doesn't work. Achieving smooth contours and skin retraction is the biggest issue clinically.

 


Appendix A

Patient information on VASER from a physician’s website:

Let VASER® LIPOSCULTURE or SMARTLIPO dissolve your liposuction fears

For the past 25 years dermatologic surgeons have been pioneers in the advancement of micro-cannular tumescent liposuction, otherwise known as liposuction under local anesthesia. Accepted as a much gentler, safer, and refined technique, microcannular liposuction has become a standard of care amongst minimally-invasive cosmetic surgeons.

Finally there are advanced technologies called VASER® Liposelection and SmartLipo that dissolve fat cells upon contact with ultrasonic or laser energy delivered through a small sterile probe, advancing the tumescent microcannular technique to the next generation of precision and ease for both the patient and surgeon. With only local anesthetic and mild sedation, the fat is melted then gently massaged and suctioned out with tiny cannulas. No more visions of the jabbing, jarring and bruising of patients associated with traditional liposuction. A Friday procedure will have you back to work and play by Monday.

What Happens During VASER® Body Sculpting?
During the procedure the area to be sculpted is filled with a special saline solution that helps numb the site and shrinks blood vessels. This solution makes the area very wet and full, making the fat cells easier to liquefy with the VASER® System's sound energy. After liquefication, the fat is removed and a pressure garment is placed for 1-3 days to tighten the skin and avoid any bruising. Small incisions heal quickly and easily.

How Does The VASER® System Work?
The VASER® System generates sound energy similar to that used for cataract removal in the eye. Small probes transmit the sound energy to dissolve fat cells on contact. Gentle suction and massage of the sculpted site removes the dissolved fat cells quickly and easily.

What Areas Of My Body Can Be Sculpted?
VASER® Body Sculpting can be done effectively on the abdomen, "love handles", backs, thighs, hips, knees, arms, neck and chin.

Is VASER® Body Sculpting Right For Me?
If you are healthy and looking for a fast, low-pain solution to your excess fatty tissue, you may be a good candidate for VASER® Body Sculpting. Although there are limits to the amount of tissue that can be removed, Dr Frank can assist you with your decision about potential areas for sculpting, the results you can expect, and the recovery process.

How Does VASER® Body Sculpting Work?
VASER® is a much gentler way of separating fatty tissues prior to removal, it differentiates between fatty tissue and other tissue such as nerves, blood vessels and connective tissues that must be left undisturbed for good results. VASER® sound energy simply bounces off other types of tissues while dissolving the less structured fat cells. This makes VASER® Body Sculpting safer and results in less swelling and a shorter and more comfortable recovery.

Where Does The Doctor Perform My VASER® Body Sculpting?
Procedures are performed in a sterile environment in our office making the procedure safe, convenient and often less costly due to the absence of hospital care and an anestheseologist.

Text from a second physician’s website:

Localized Fat Spot Reduction (“MesoSculpting”)

The use of Mesotherapy for localized fat areas is part of the treatment group known as Injection-Lipolysis, which includes treatments like Lipodissolve, Lipostabile and Mesosculpting.

 By injecting the fat-dissolving natural substance Lecitin combined with other enabling substances, localized fat deposits will slowly be reduced.

“The original method, which is comparatively simple and especially suitable for small fat deposits, due to its simple injection technique, the method has its limits. For good results, the treatment usually has to be repeated”.

MesoSculpting is ideal for patients who wish to remove small amounts of fat deposits on arms, hips, abdomen, thighs, neck, chin and other “hard to get” areas and who find liposuction “too much” or “too invasive”. For patients who have already had liposuction, but are now finding fat depositing in other areas, MesoSculpting is the answer. However, the technique is not a complete replacement for liposuction.

A series of treatments (5-15) are given spaced one to two weeks apart. Where successful, visible results, usually measured in inches, are usually considered long lasting when combined with regular exercise and healthy life style. The total number of required treatments will vary for each individual patient.


Appendix B

The Smartlipo LaserBodySculpting Workstation provides aesthetic surgeons with a less invasive technique than conventional liposuction methods. As the industry's only laser-assisted lipolysis system designed to destroy fat cells and coagulate tissue for tighter skin, Smartlipo is ideal for treating localized fat deposits on the face and body.

In addition, Smartlipo can easily treat challenging areas—such as regions of high vascularity and flaccidity.

The Biggest Results—In The Smallest Of Places

The Smartlipo laser-assisted lipolysis system is a highly efficacious solution for destroying and permanently eliminating fat cells:

  • A 1064-nm Nd:YAG laser fiber is introduced through a small cannula, delivering energy directly to subcutaneous fat cells-causing them to rupture. The emitted energy also coagulates tissue, thus inducing collagen retraction and tissue tightening.
  • The laser causes small blood vessels to coagulate immediately—resulting in less bleeding, swelling and bruising than conventional liposuction, for faster healing and recovery.
  • Given the cannula's small size and gentleness of the procedure, Smartlipo is a minimally invasive treatment that only requires local anesthesia—enhancing client safety and reducing the likelihood of side effects.
  • A confluent red diode laser provides a powerful visual guide during treatment.
  • Typically only one short treatment session is needed—enabling you to maximize your client throughput.

List Price:  $94,500

Introduced in November 2006

Energy Sources:  Nd:  Yag

 


Appendix C

A prospective, randomized, double-blind, controlled clinical trial comparing laser-assisted lipoplasty with suction-assisted lipoplasty.

Prado A, Andrades P, Danilla S, Leniz P, Castillo P, Gaete F. 

Plast Reconstr Surg. 2006 Sep 15;118(4):1032-45. 

 

BACKGROUND: The authors randomized and prospectively analyzed their clinical experience with the use of internal neodymium:yttrium-aluminum-garnet low-level laser-assisted lipoplasty compared with suction-assisted lipoplasty. METHODS: Suction-assisted lipoplasty was generated through a SmartLipo machine and delivered into the subcutaneous tissues through 2-mm solid optical probes. Ipsilateral suction-assisted lipoplasty and contralateral laser-assisted lipoplasty were performed on one or more comparable topographic areas of the body in the same patient. Laser-assisted lipoplasty and suction-assisted lipoplasty sides of 25 patients were compared with preoperative and postoperative photographs at 3 to 5 days, 12 to 15 days, and 6 to 11 months. Statistical analysis considered surgeon and patient satisfaction, time used in the procedures, learning curves, lipocrits, operative technique, postoperative pain, edema, ecchymosis, time of recovery, body mass index, DNA proteins, free fatty acids, and cytologic patterns of post-laser-assisted lipoplasty and suction-assisted lipoplasty adipocyte architecture. Photographs were sent to the patients (blinded to the operated sides) and two plastic surgeons unfamiliar with the cases for evaluation of results. RESULTS: All patients completed the preestablished follow-ups. No complications were observed. Less pain, lower lipocrits, higher triglycerides, and DNA cellular membrane traces were detected in the laser-assisted lipoplasty sides. All other considerations studied showed no differences with either technique in the three periods of the follow-up controls. Cytologic studies showed more damage of the adipocytes in the laser-assisted lipoplasty sides. CONCLUSIONS: No major clinical differences for suction-assisted lipoplasty versus laser-assisted lipoplasty were found. Higher concentrations of free-fatty acids after laser-assisted lipoplasty must alert us to possible hepatic and renal toxicity.

 

Submental Nd:Yag laser-assisted liposuction.

Goldman A.

Lasers Surg Med. 2006 Mar;38(3):181-4. 

BACKGROUND: Liposuction of the neck is currently one of the most common cosmetic surgical procedures. In the present study, the author describes his experience with neck and jowl laser-assisted liposuction. STUDY DESIGN/MATERIALS AND METHODS: In this procedure, submental lipodystrophy is treated with an Nd:YAG laser, at a 1,064 nm wavelength. Over a 5-year-period, 82 subjects were treated using 6-W power, 40-Hz frequency, 150-mJ energy, and 100-microsecond pulse width parameters. Histology was performed on fatty tissue samples. RESULTS: Submental laser-assisted liposuction resulted in significant cosmetic improvement. Histology revealed a rupture of the adipocyte membrane as well as collagen coagulation and channels along the fatty tissue. Additionally, small blood vessels were coagulated. An adequate skin contraction was observed with an improvement of the cervicofacial region. CONCLUSIONS: The Nd:YAG laser is a useful tool for the treatment of local lipodistrophy. The laser proved to be effective for cellular lysis and collagen neoformation.

 

Laser lipolysis using a novel 1,064 nm Nd:YAG Laser.

Kim KH, Geronemus RG.  

Dermatol Surg. 2006 Feb;32(2):241-48; discussion 247. 

BACKGROUND: We studied the safety and efficacy of a 1,064 nm neodymium:yttrium-aluminum-garnet (Nd:YAG) laser with a 300-micron fiber for the reduction of small unwanted fat areas. METHODS: Thirty subjects with focal areas of fat less than 100 cc were enrolled. Ten subjects were treated with laser lipolysis and had magnetic resonance imaging (MRI) at baseline and 3 months post-treatment. Ten subjects had laser lipolysis followed by biweekly treatments with the Tri-active system. The last group of 10 subjects served as control. Patients were seen at baseline and 1-week, 1-month, and 3-month follow-up visits. RESULTS: Twenty-nine patients completed the study. Self-assessment evaluations reported an improvement of 37% at the 3-month follow-up visit. MRI demonstrated an average 17% reduction in fat volume. Smaller baseline volume areas, such as the submentum, had better results, suggesting a dose-response relationship. The most common side effects were mild bruising and swelling resolving within 2 weeks. CONCLUSION: Laser lipolysis using the 1,064 nm Nd:YAG laser with a 300-micron fiber appears to be a very promising procedure that delivers good, reproducible results safely and effectively. The advantages include excellent patient tolerance, quick recovery time, and the benefit of dermal tightening.

 

Histologic evaluation of the pulsed Nd:YAG laser for laser lipolysis.

Ichikawa K, Miyasaka M, Tanaka R, Tanino R, Mizukami K, Wakaki M.

Lasers Surg Med. 2005 Jan;36(1):43-6. 

BACKGROUND AND OBJECTIVES: Laser lipoplasty with pulsed Nd:YAG laser, widely used in Europe and Latin America, has recently been introduced in Japan and the USA. We report histologic analyses of the effects of the laser on human fat tissue. STUDY DESIGN/MATERIALS AND METHODS: Freshly excised human skin and subcutaneous fat were irradiated with the pulsed Nd:YAG laser (SmartLipo, DEKA, Italy). A 1,064 nm laser at 40 Hz and 150 mJ and 100 microseconds-long pulses were used. Methods of exposure were the same as in the clinical application. In the control group, the specimens were cannulated by the handpiece without irradiation. The tissue was studied by scanning electron microscopy and hematoxylin eosin staining. RESULTS: Scanning electron microscopy after irradiation showed greater destruction of human adipocytes than in the control. Degenerated cell membrane, vaporization, liquefaction, carbonization, and heat-coagulated collagen fibers were observed. CONCLUSIONS: Our study showed that the SmartLipo appeared to be histologically effective for destruction of human fat tissue.

 

 

 

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