FDA Clears Apyx Medical’s Renuvion Handpiece for Improving Lax Skin
The Renuvion APR Handpieces are now indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax skin in the neck and submental region.
The FDA granted 510(k) clearance for the use of Apyx Medical’s Renuvion APR Handpiece for certain skin contraction procedures.
Specifically, the Renuvion APR Handpieces are now indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.
“Apyx Medical is proud to announce the receipt of this FDA 510(k) clearance, as now Renuvion is the only device that is FDA-cleared for improving the appearance of loose skin on the neck and chin,” says Charlie Goodwin, President and Chief Executive Officer. “This represents a watershed moment for our company on our journey to revolutionize the cosmetic surgery market by bringing transformative solutions to our customers. We can now market and sell Renuvion to surgeons and patients for use in the approximately 200,000 neck contouring procedures performed in the US annually. Our clinical and regulatory teams have worked diligently over multiple years to make this achievement possible, and I would like to thank them for positioning us to achieve this clearance.”
BTL Launches EMSCULPT NEO Edge Applicator for the Lateral Abdomen
BTL is launching the new Edge Applicators to treat the entire lateral abdomen. Shipping will begin in September 2022.
Designed to allow for a better contour of the curvy areas of the body, such as the lateral abdomen, the Edge applicator utilizes radiofrequency and HIFEM technology to simultaneously address fat deposits and muscle groups in the lateral abdomen region. Further, the new device extension tones the oblique muscles when treating the lateral abdomen, and many patients experience a significant improvement in their posture, core, and back discomfort.
“With the exciting new addition of the Edge applicator, BTL is continuing to raise the bar in the aesthetics industry and innovate for versatility by extending the sculpting power of the award-winning Emsculpt NEO therapy. The unrivaled device treats more key muscle groups than any other non-invasive treatment,” says Ron Borsheim, Vice President of Product Development.
When launched in 2018, the Emsculpt therapy was the only treatment to use HIFEM technology to build muscle and sculpt the body in a 30-minute session. Emsculpt NEO, launched in 2020, expanded upon its predecessor’s capabilities by simultaneously delivering heat and magnetic energy. The result is more fat reduction and more muscle growth than any single gold standard product. Clinical studies have shown that, on average, patients experience a 30% fat reduction and a 25% increase in muscle in the treated area.
FDA Approves Sientra’s Low Plus Profile Projection Breast Implant
The FDA approved Sientra’s Low Plus Profile Projection Breast Implant for breast augmentation in women at least 22 years old, and for women of all ages undergoing breast reconstruction.
This product will be commercially available for board-certified and board-eligible plastic surgeons in the United States in late July 2022.
“I am excited that I will now have this new FDA-approved Sientra implant option for my patients, as it fills a formerly unmet need between the low profile and moderate profile implants Sientra already offers,” says Bradley M. Calobrace, MD, a KY-based board-certified plastic surgeon, in a news release. “Now when I utilize Sientra’s new Low Plus Profile Projection Breast Implant, my patients will get the natural look with the upper pole fullness they desire.”
Sientra will be the first and only implant maker within the US to offer 80cc and 110cc gel implants. These two new sizes will bring more options to surgeons and their patients.
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A Focus on Regenerative Medicine
At the Aesthetics Innovation Summit, Atta Behfar, MD, PhD, Founder and Chief Executive Officer, Rion, discussed the 20 years of research in regenerative medicine behind the company’s Purified Exosome Product that drives soft tissue healing. Visit ModernAesthetics.com/ais to watch Dr. Behfar discuss the future of regenerative medicine. Plus, watch other speakers share highlights from the meeting.
Cynosure Launches Tempsure eyeEnvi Handpiece with Improved Function and Comfort
Cynosure’s new Tempsure eyeEnvi handpiece features an ergonomic pencil grip design and lighter piston tension required to activate the treatment, making it more comfortable for both patient and provider, heating thinner tissue more effectively and comfortably while minimizing hand fatigue. The electrode glides more smoothly on the face, and the improved tip design provides greater treatment area visibility to target smaller treatment areas around the eye with ease.
The new handpiece is ideal to use with the new, science-backed signature Energy Blends by Cynosure and its Eye Beauty Blended Treatments: Tempsure Envi/Icon MaxG/B.E. Beautiful Energy Skincare. This blend combines proven Cynosure technologies for comprehensive eye enhancements. It blends RF heat treatments to stimulate and remodel collagen and elastin production with intense pulsed light and topicals to treat the reds, browns, and texture of the delicate skin surrounding the eye.
Energy Blends by Cynosure utilize proprietary technologies to offer a comprehensive multi-modal approach to superpowered skin, combining multiple treatment options that are designed to work sequentially to target myriad of skin concerns, all in one protocol and with minimal downtime. Each Energy Blends treatment combines the use of B.E. Beautiful Energy skincare, Cynosure’s line of pre- and post-treatment topicals designed to complement laser and energy-based treatments. Dermatologist-curated and clinically researched, the medical-grade skincare line works synergistically with advanced procedures to deliver professional results at home.
Ice-slurry Injections May Melt Subcutaneous Fat
Cryolipolysis with injectable ice-slurry may soon become an efficient, effective and customizable method of body sculpting, according to new research in Lasers in Surgery and Medicine.
The basic science report, led by Lilit Garibyan, MD, PhD and Peiyun Ni, MD, used modeling to determine the dosimetry for injectable ice-slurry treatments and demonstrated the important role that the physical properties of the slurry and the composition of target adipose tissue can play in treatment outcomes.
“We had already demonstrated that ice-slurry injection is a novel method for efficient and effective subcutaneous adipose tissue reduction,” says Dr. Garibyan. “We did the current study to better understand the heat exchange and phase changes that occur after ice-slurry injection into subcutaneous tissue. This work is important as it helps determine the important parameters of ice-slurry and adipose tissue that influence the amount of fat reduction with this treatment.”
Promising Data for Galderma’s RelabotulinumtoxinA
Galderma’s investigational RelabotulinumtoxinA, a novel liquid formulation botulinum toxin A, improves both glabellar and lateral canthal lines with a rapid onset of action and a long duration up to 6 months, according to top-line Phase 3 data presented at the Vegas Cosmetic Surgery & Aesthetic Dermatology meeting.
RelabotulinumtoxinA is designed as a liquid, avoiding the traditional requirement to reconstitute from powder, eliminating variability, errors and risks associated with reconstitution, which would be expected to improve the consistency of results. The READY (RElabotulinumtoxin Aesthetic Development StudY) phase 3 clinical program is composed of four Phase 3 clinical trials that enrolled more than 1,900 participants. Data presented at VCS came from two of the studies.
Both studies met their primary endpoint, demonstrating a significant ≥2-grade composite improvement (as assessed by subject and investigator) in glabellar line severity and lateral canthal line severity vs. placebo at Month 1, with rapid onset of action and up to 6-month duration of action.
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