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FDA Clearances: BTL Aesthetics, Syneron-Candela

The FDA awarded BTL Aesthetics a new designation for it non-invasive fat reduction treatment, BTL Vanquish ME: the circumferential reduction of the abdomen and thighs. The clearance was secured following several rounds of clinical testing to provide evidence of efficacy and safety—previously documented in two studies published in peer-reviewed journals.

Harnessing the power of high-frequency, selective RF energy, BTL Vanquish ME induces death of fat cells through apoptosis, and the body flushes fat cells out of the body naturally to help slim the abs, belly, love handles, and now thighs. With the largest spot size in the industry, the unique contactless panel allows patients to treat a broad area at once, resulting in more even results with no lines of demarcation, the company says. Similar to treatment of the abdomen, which covers the core from flank-to-flank, the Flex Applicator—specially designed to treat and adjust to the thighs—simultaneously slims both the inner/outer thighs and saddle bags. This allows for enhanced patient outcomes, shorter treatment times and elimination of additional consumable costs for the physician.

In clinical studies, more than 80 percent of subjects experienced a statistically high and significant circumferential reduction with four, 30-minute treatment sessions per leg, delivered once a week over a four-week period.

The FDA also cleared Syneron Medical Ltd.’s PicoWay picosecond laser for a new ultra-short 785nm wavelength. The addition of the new wavelength expands the capabilities of the PicoWay picosecond laser, making it possible to remove all tattoo ink colors including blue and green. It will be available in the fourth quarter of 2016, the company states.

The FDA clearance of the new third wavelength was supported by a 15-patient study, covering 22 tattoos, of which 18 contained blue and green inks. Blinded evaluation of tattoo clearance, by independent board-certified physicians, showed that 83 percent of the treated blue/green tattoos had “good” to “complete” treatment response after two PicoWay treatments with the 785nm wavelength. Moreover, investigator assessments of tattoo clearance showed similar results to blinded evaluation findings.

There were no treatment complications, and PicoWay treatments were generally associated with no discomfort to mild discomfort for the majority of treatments.

Syneron Medical Ltd.’s non-invasive fat destruction device, UltraShape Power, is now FDA cleared for non-invasive reduction of abdominal circumference via fat cell destruction.

UltraShape Power uses focused, pulsed mechanical ultrasound energy to target and destroy fat, offering measurable fat reduction to the abdominal area. UltraShape Power’s USculpt transducer delivers 20 percent more energy than its predecessor. A recent clinical study with UltraShape Power’s USculpt transducer documents a 32 percent reduction in subcutaneous fat thickness.

UltraShape Power’s ultrasound energy is applied to the skin in a proprietary pulse structure to ensure effective fat destruction with no damage to surrounding tissue including blood vessels, nerves and muscles, resulting in a safe and comfortable treatment experience. UltraShape Power’s lighter transducer for high maneuverability enables the customized treatment of large and small fat pockets. The device also incorporates a sophisticated treatment and patient management software package.

Study: Many Lice Now Resistant to Common OTC Treatments

Fully 98 percent of head lice in at least 42 states are resistant to various over-the-counter pyrethrins and pyrethroids including permethrin, which is the active ingredient in popular treatment formulations for pediculosis (Nix (permethrin 1%), according to a study in the Journal of Medical Entomology.

The research, published in March 2016, is now being highlighted by ParaPRO, a specialty pharmaceutical company developing new antiparasitic formulations.

The study was designed to determine the extent and magnitude of the knock-down resistance (kdr)-type mutations responsible for the increasing prevalence of head lice resistant to common treatment formulations. Between July 22, 2013 and May 11, 2015, lice were collected from 138 sites in 48 US states and analyzed by quantitative sequencing. Previously published data were used to compare changes in the frequency of the kdr-type mutations over time. The overall mean percent resistance allele frequency (mean % RAF) (+/-SD) for all analyzed lice was 98.3 +/- 10 percent.

Forty-two states (88 percent) had a mean percent RAF of 100 percent, the study showed. The frequencies of kdr-type mutations did not differ regardless of the human population size. The study correlated the loss of efficacy of the Nix formulation (Prestige Brand, Tarrytown, NY) from 1998 to 2013 to the increase in kdr-type mutations. The results demonstrated a parallel increase of kdr-type mutations in lice over time, which provide a plausible reason for the decrease in the effectiveness of permethrin in Nix.

Specifically, the percent of lice-free patients following treatment by the OTC Nix formulation was essentially 100 percent from 1986 to 1998, but from 1998, the overall effectiveness of the Nix formulation steadily declined and was only 25 percent effective by 2009, a 75 percent decline in overall effectiveness in clinical trials over 10 years, the study showed.

Derm Groups Disagree with New Skin Cancer Screening Recommendation

The US Preventive Service Task Force (USPSTF) has declined to take a stance on the value of preventive skin cancer screenings for the second time in seven years, saying there is insufficient evidence to make a recommendation on whether the benefits of routine screenings by a physician outweigh the harm.

Many dermatology groups are disappointed with the decision of USPSTF. “Dermatologic surgeons—who are the experts in skin disease treatment—do not believe this ‘insufficient evidence’ recommendation is accurate,” said American Society for Dermatologic Surgery (ASDS) President Naomi Lawrence, MD, in a statement. “Screenings often lead to the early detection and treatment, which lead to better outcomes and higher survival rates for patients.”

The Melanoma Research Foundation (MRF) is also urging the USPSTF to reconsider their recent announcement stating that insufficient data exists to support a recommendation for annual skin cancer checks.

“This has the potential to undo years of effort to lower the rate of the fastest growing cancer in the United States,” said Tim Turnham, Executive Director of the MRF, in a statement.

The recommendation that screenings not be considered a preventive health care service was made by a panel of research experts. Dr. Lawrence noted that the task force does recommend that adults who have already had skin cancer, those at high risk (e.g., fair-skinned, light eye color, or history of significant sun exposure) or those with changes to their skin consult with their physician.

“However, even those not at high risk for the disease can benefit from skin cancer screenings,” she said. “Screenings can provide early detection when the disease is most curable as well as educate patients on the importance of skin self-exams and sun-safe behaviors.”

Dr. Lawrence said it’s important for the public to understand the panel’s findings do not advise against skin cancer screenings. “ASDS member dermatologists are worried the public will misinterpret the findings and avoid regular screenings. Instead, the task force is making no recommendation,” she said.

The USPSTF says “insufficient data exists” to support annual skin checks. “Sadly, many will read this to mean that annual skin checks are unimportant. In fact this statement means only that the critical research needed to generate such data has not been done,” Turnham said. “This research is important, but time-consuming and costly. The data to support annual skin checks is not likely to be available for many years—if ever. Meanwhile, people may become casual about self-examinations and annual skin checks because they misunderstand the USPSTF statement.”

The American Society for Dermatologic Surgery Association (ASDSA) noted it has worked extensively to institute reforms at USPSTF. As a member of the Alliance for Specialty Medicine, ASDSA sent representatives to Capitol Hill for the second consecutive year to lobby for the passage of HR 1151, the “USPSTF Transparency and Accountability Act of 2015.”

This legislation would require justification for USPSTF recommendations and publication of research plans as well as allow for public input. n


BEVL Blasts Off: New Mobile Network Seeks to Connect Aesthetic Pros

A new mobile network that connects medical aesthetics professionals, BEVL is now accessible via iOS, Android and the web. Physicians and professionals across the medical aesthetics industry to message, ask questions, contribute what they are learning and share practical ideas for improving both the business and clinical sides of aesthetic practice.

FDA Issues Draft Updated Recommendations on Submitting New 510(k)

The draft recommendations describe how manufacturers should consider the risk presented by the device modifications when determining if they should submit a new 510(k). When finalized, they will replace an earlier guidance issued in 1997.

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