AeroForm Tissue Expander System FDA Cleared

AeroForm Tissue Expander System FDA Cleared

AirXpanders has received U.S. Food and Drug Administration (FDA) de novo clearance for the AeroForm Tissue Expander System, a Class II medical device used for breast reconstruction following mastectomy. The needle-free device is activated by a handheld wireless controller that administers programmed amounts of CO2 (up to three times a day) to gradually stretch the tissue. Clinical data demonstrated that patients who used the device safely achieved full expansion in weeks (rather than months) and completed their reconstruction faster than with traditional, saline-based expanders.

FDA Issues Guidance on Medical Device Cyber Security

FDA Issues Guidance on Medical Device Cyber Security

The U.S. Food and Drug Administration (FDA) has released a new draft guidance on the post-market management of medical device cyber security, a response to ever-evolving technology, and hence, increased risk of cyber breaches that could affect devices’ functionality throughout their life cycles. It complements an earlier final guidance issued in October 2014.

This new guidance outlines steps the FDA recommends manufacturers take to continually manage cyber security risks, including:

Next-Generation BTL Vanquish ME for Fat Reduction

A study published in the Journal of Drugs in Dermatology (December 2016) found that the BTL Vanquish ME (Maximum Energy) from BTL Aesthetics was effectively redesigned for more efficient and homogenous energy delivery to targeted tissue, reducing 53% more fat versus the BTL Vanquish. The BTL Vanquish ME, which debuted in 2015, is FDA-cleared for the circumferential reduction of the abdomen and thighs.

Cutera Launches PICO Genesis

Cutera has introduced the PICO Genesis, a new nonthermal approach for the treatment of pigmentary skin concerns using the Enlighten picosecond laser system. The procedure uses ultra-short laser pulses that deliver a shockwave effect to selectively shatter pigment, and disrupt and remodel the upper dermis for a brighter, more uniform complexion. It takes about 20 minutes from start to finish, is pain-free and requires very little downtime.

CO2-Based Tissue Expanders Effective in Breast Reconstruction

A study published in Plastic and Reconstructive Surgery (December 2016) compared AeroForm—a remote controlled, needle-free CO2-based expander—to saline tissue expanders.

The researchers randomized 150 women undergoing two-stage breast reconstruction at 17 U.S. sites. Subjects performed expansion in 10cc increments, up to 30cc per day of CO2. Physicians treated the control arm with periodic bolus injections of saline. Safety endpoints, expansion and reconstruction times, pain and satisfaction were assessed.

Energy-Based Treatments Safe After PMMA Injections

Energy-Based Treatments Safe After PMMA Injections

In a recent study, researchers Douglas C. Wu, MD, et al, evaluated the safety and histopathological effects of different laser, light and ultrasound modalities on skin previously injected with a polymethylmethacrylate (PMMA) filler (Bellafill, Suneva Medical).

Bellafill is a soft tissue dermal filler composed of non-resorbable microspheres, suspended in a water-based carrier gel with 3.5% bovine collagen; it is FDA approved for the correction of nasolabial folds and atrophic facial acne scars.

Sciton Halo Wins MyFaceMyBody Americas Award

Laser and light device manufacturer Sciton was presented with the 2016 MyFaceMyBody Award for Best Anti Aging Treatment for its Halo device. The hybrid fractional laser combines an ablative and nonablative wavelength to treat the deep and superficial layers of skin. A single treatment improves a number of aging concerns—including tone, texture, pigment irregularities and pore size—with minimal downtime.

HydraSolve May Increase Fat Graft Viability

Spencer A. Brown, PhD, director of surgical research at Cooper University in Camden, New Jersey, presented the latest results from his research on the characterization of HydraSolve lipoaspirate (fat) during the International Federation for Adipose Therapeutics and Science (IFATS) San Diego 2016 conference. HydraSolve is a liposuction device from Andrew Technologies that uses the company’s proprietary Tissue Liquefaction Technology (TLT), which combines natural saline solution with low levels of temperature and pressure to liquefy only targeted fat tissue.

Selective Ablation

Achieving optimal outcomes with fractional ablative lasers.
Selective Ablation

Fractional laser delivery has expanded the option of ablative laser resurfacing to a much broader base of patients. Providers can prescribe treatments based on specific concerns, skin types and even individual downtime requirements. But in order to achieve the safest and most effective treatments, you need to know your individual devices well and keep a close eye on both clinical endpoints and patient selection. “Perform a physical exam to make sure the patient is healthy and doesn’t have any conditions that would interfere with the healing process,” says Michael H.