LipoSonix Not FDA Ready

Streetinsider.com reported recently that the FDA issued a letter to Medicis, the maker of Dysport®, notifying the company that data presented in the 510(k) application to market the LipoSonix system was insufficient. According to the FDA, Medicis must file a new submission with additional information before LipoSonix can be marketed in the U.S.

The FDA's letter to Medicis offered guidance as to the additional information needed to obtain 510(k) clearance. Medicis plans to pursue a meeting with the FDA to present the additional data and to formulate the next steps. The letter from the FDA did not request nor highlight any missing safety data and acknowledged that the agreed primary endpoint of the clinical trial was achieved.

LipoSonix technology uses ultrasound energy to destroy fat cells without harming the skin. The destroyed fat tissue is transported to the liver where it is processed as energy. The treated fat is permanently removed, leaving the patient with a slimmer, more contoured body.

According to Medicis, the LipoSonix system is unlike body contouring technologies because it is highly targeted and has the ability to concentrate energy at specific depths of abdominal fat. By doing so, underlying tissues and non-targeted areas are not damaged.

Results are typically seen in about 8 to 12 weeks. LipoSonix is currently available in Canada, France, Germany, England and Spain.

The Aesthetic Show: Add the Soniceye to upcoming hot list

While in Vegas last weekend I also attended and lectured at The Aesthetic Show, run by Michael Moretti, publisher and editor of the Aesthetic Guide - this is a huge show that included many specialties. I lectured on fractional resurfacing, specifically on Sciton's erbium profractional and the many studies we have performed at SMAC with this device, and on non-surgical fat removal with Ultrashape, Liposonix and Zeltiq.

There were many excellent presentations, including NJ's Dr. Barry Dibernardo and Brazilian plastic surgeon Alberto Goldman on laser liposuction. Diane Duncan gave and excellent update on the Invasix's RFAL - Bodytite machine that i have been working on as well. More to follow from this meeting over the next few days with a guest blog.


The best part of this meeting was the new toys from industry. The coolest thing I found was a device called Soniceye, distributed by Sound Surgical Technologies (who sell the VASER system). This device is a hand held ultrasound transducer developed for the Department of Defense to be used in the battlefield, to help with intravenous access of wounded soldiers. There is a heads up display, and you can see me testing the device in the photo above. Might be great someday for liposuction or vein treatment. More to come!!!!

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center, Boca Raton
Sanctuary Plastic Surgery, Boca Raton

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center, Boca Raton
Skin Laser Surgery Specialists of NY/NJ

A new twist on Latisse, and more from the Annual Cosmetic Dermatology Meeting

I have just returned from co-directing the Annual Cosmetic Dermatology-Santa Monica Meeting. The meeting, directed by me and Dr. Christopher Zachary, Chairperson of Dermatology at the University of California –Irvine, was highlighted by discussions about 1) Dysport – the new competitor to Botox; 2) new techniques for body contouring; 3) novel approaches for the use of wrinkle fillers; 4) the benefits of cosmetic camouflage; 5) nuances of Latisse, the new eyelash enhancer; and 6) a look at the aging process of the face.

Dysport, the newly FDA approved wrinkle relaxer, will be available to US physicians over the next month. Based on the European experience with this product, US physicians are expected to embrace the new Botox competitor. In Europe, Dysport has been very popular for both wrinkles and excess sweating. Of note, the amounts to be injected are different than Botox. Patients will need to be certain injections are undertaken by experts so as to receive the appropriate response while lessening the chance of complications.

Cryolipolysis by Zeltiq, Focused Ultrasound by UltraShape and Liposonix (Medicis) are all expected to have a major impact on non-invasive body contouring. Although the results do not appear as profound as those seen with surgery, the non-surgical nature of these techniques should make them highly popular. What is not at all clear is when the FDA will approve these methods.

Wrinkle fillers are commonly used for smile lines. However the meeting focused on the use of such fillers for creating 1) a more natural lip appearance and 2) gently lifting droopy eyebrows. However, with any technique some bruising is possible. Dr. Howard Steinman, an expert in cosmetic mineral based camouflage techniques, taught attendees how to hide injection induced bruising.

We also learned some of the nuances of Latisse, the newly FDA approved eyeliner enhancer. It seems that although life-long use is required to keep eyelashes thick, the daily applications initially required may not be required with time. Finally, Dr. Val Lampros, a California based plastic surgeon, gave a fascinating lecture on the 3 dimensional changes that occur in all of our faces over the course of our lives. By understanding this, techniques for cosmetic improvement will continue to improve.

The meeting was highly educational. Santa Monica was fun. I will be back there again in a year.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center, Boca Raton
Sanctuary Plastic Surgery, Boca Raton

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center, Boca Raton
Skin Laser Surgery Specialists of NY/NJ

Florida Society of Dermatology and Dermatologist Surgery Meeting Wrap-up

Just attended the Florida Society of Dermatology and Dermatologic Surgery (FSDS) 2009 annual meeting in Boca Raton, Florida at the gorgeous Boca Raton Resort and Club.

Luckily this is only a few miles from our office so none of the usual trauma of getting there! I gave 3 lectures - thefirst on fractional resurfacing, the second on non-invasive fat removal including Ultrashape, Liposonix and Zeltiq), and the third on body skin tightening and cellulite with the Alma's Accent RF device.

Dr. James Spencer, president of the society, ran a wonderful meeting. There were some excellent presentations by local and visiting doctors.

Dr. William Coleman, a dermatologist from from New Orleans and editor of the prestigious Journal of Dermatologic Surgery also presented on the Ultrashape device as well as on injection lipolysis and mesotherapy.

Mark Nestor and Glynis Ablon gave excellent laser lectures on Sciton and Syneron devices.

Joel Cohen of Denver spoke about filler complications and their management and Stephen Mandy of Miami beach (I found out he was a former race car driver!) gave excellent talks on fillers and facial rejuvenation.

All in all - excellent meeting!!!!

Thanks for reading,

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center, Boca Raton
Sanctuary Plastic Surgery, Boca Raton

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center, Boca Raton
Skin Laser Surgery Specialists of NY/NJ

What happened in Vegas at ASAPS...

Greetings after a great meeting of the American Society for Aesthetic Plastic Surgery in Las Vegas.



The Hot Topics seminar was very interesting today. I gave a talk on Ulthera for neck tightening. It generated a lot of interest... see previous posts for more on it, but it looks like they are progressing with their technology. No word yet on FDA approval.

Dr. Michael Kulick from San Francisco presented his Eleme Smoothshapes results for cellulite. Very scientific study with 3-d vectra analysis. and it showed the best cellulite results I have ever seen.

Dr. Mark Jewell presented Liposonix and Jeffrey Kenkel presented Ultrashape data. Very good fat reduction results from both companies. Dr. Sydney Coleman presented some of the latest research on Zeltiq, which as you know from reading this blog, freezes fat to eliminate it. All of these fat reduction technologies are looking good.

Dr. Malcolm Paul presented the latest RF-assisted liposuction results with Invasix Bodytite. Very significant skin tightening! Dr. David Kung presented Bodyjet water assisted liposuction - technology looks good for fat harvest, and it's been in the media a lot for the novelty of the water.

V. Leroy Young presented an update on Juvista update; great early clinical work for this scar reduction technology. We'll be hearing more about it later on.

Dr. Louis Bucky presented on fat grafting to the breast and Dr. Coleman made some excellent comments. It looks like this procedure is getting much more established. I guess I should start doing this in Boca Raton!

Currently I have been using it for correcting some breast augmentation complications but it may be time to start using for augmentation.

Finally, Reloxin is no longer Reloxin, I guess they are going to use the European name of Dysport.

Thanks for reading,

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center
Sanctuary Plastic Surgery

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin Laser Surgery Specialists of NY/NJ

IMCAS Wrap Up: Day 2

Drs. Michael Kane and Mark Jewell presented the initial science behind Liposonix, while Dr. Afschin Fatemi from Germany presented his early clinical experiences. Most interesting were the combined deep and superficial treatments he performed with this ultrasound device. Dr. Goldberg recently talked about ultrasound devices with Self Magazine (PDF).

Dieter Manstein, MD presented his work with the Zeltiq cryolipolysis device, which Dr. Goldberg is also working with for a clinical study. For the uninitiated, Cryolipolysis is a patented method that removes fat via a precise cooling process.

It's going to be an interesting next few years with the war between the fat removal devices. We posted on this a few months ago after the ASPS conference. Dr. Goldberg was a coauthor of an abstract recently presented about the early clinical wok with the Zeltiq device.

Here's Dr. Goldberg sharing a moment with Bob Tyson from Zeltiq at their booth:

On another note, it was standing room only in the lectures about fractional laser resurfacing. Many physicians presented about the different fractional lasers out there, including Dr. Goldberg and myself. I spoke about fractional laser complications as did Dr. Christopher Zachary shown in the photo below sharing a moment with Dr. Michael Kane.

Visit to one of the first med-spas in Toronto

I spent some time over Thanksgiving visiting with Dr. Steve Mulholland, of SpaMedica in Toronto. I toured his facility, which was spectacular and will be even better after an upcoming renovation. SpaMedica was one of the first medi-spas out there and was an inspiration for SMAC in Boca Raton.

Canada has different rules when it comes to testing and approving new devices, so Steve has a bit of an advantage there when it comes to new technology. We're still testing the Ultrashape but he's been using it in his practice for some time, since it's already approved in Canada. He combines it with Velashape to get some more cellulite removal.

Pretty soon he'll be getting the Liposonix device from Medicis. It's similar to what Ultrashape does, but it's more thermal and supposedly has tighter skin contracture, albeit with more pain. I trust Steve's judgment so we'll see what he says about it. Maybe he should do a split body study on love handles, where each side is treated with a different machine.

He gave me the scoop on some other upcoming technologies that I'll be talking about later.

That is all,

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

Back from the ASPS conference...

I'm back to work after the annual meeting of the American Society of Plastic Surgeons in Chicago. The best part is always getting an insider's preview of the upcoming technology that no one else has seen yet.

On Monday, I was on a panel hosted by Dr. Daniel Dubin (Vice Chairman of Leerink Swann, founder of MEDACorp) about non-invasive body contouring technology.

The main focus was on non-surgical fat removal and centered around three devices that are awaiting FDA approval:

The first two are very interesting ultrasound devices. The UltraShape and Liposonix both use ultrasound waves to break up fat deposits, which the body then treats as regular fat and flushes them out via the liver. Liposonix was acquired by Medicis a few months ago, so along with Reloxin they'll have a lot of new products coming out next year.

The third is the Zeltiq. It uses a process called Cryolipolysis, which precisely cools fat to induce it to break down.

FYI: Our practice in Boca is actually one of six sites in the country that are conducting FDA tests for the UltraShape, while Dr. Goldberg is conducting Zeltiq tests at Skin and Lasers in New Jersey.

These are absolutely the newest non-invasive procedures and pending FDA approval, you'll be reading about them in every women's magazine and seeing them done on TV in a couple of years.

Dr. Jason Pozner,
Sanctuary Plastic Surgery