A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

VersaWrap Nerve Protector Receives 510(k) Clearance Reports Alafair Biosciences

September 24, 2020

The VersaWrap nerve protector received 510(k) clearance from the FDA. Alafair Biosciences announced the news today. Similar to VersaWrap® Tendon Protector indicated for tendon.

VersaWrap Nerve Protector is an ultrathin, sutureless, bioresorbable hydrogel implant ideally suited for covering and protecting peripheral nerves. By forming a permeable, gelatinous layer on or around the peripheral nerve, VersaWrap® provides a non-constricting interface between nerve and surrounding tissues during healing.

“VersaWrap is an exciting new product. We’ve been searching for something like this, a device that is pliable, that improves gliding, and that bioresorbs, to address adhesions,” stated Dr. Harvey Chim, MD, a plastic surgeon in Gainesville, FL. “Given the presence of hyaluronic acid in VersaWrap, the technology and its mechanism of action in tendon and peripheral nerve procedures makes sense. I’ve seen it work well in a variety of cases where scarring was a concern.” Dr. Chim has been using VersaWrap Tendon Protector for several years. “I use VersaWrap because my patients have better clinical outcomes.”

“We are pleased to have received 510(k) clearance for VersaWrap and believe that we will see rapid surgeon adoption given the unique characteristics of our product,” said Greg Brophy, CEO of Alafair. “Our patented hydrogel technology has diverse applications in the medical device and regenerative medicine segments, and the extension of our product portfolio to include peripheral nerve procedures is a substantial milestone for our organization.”

VersaWrap® is the second product in the VersaWrap® family of products to receive 510(k) clearance and is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue. Alafair anticipates additional 510(k) filings as it seeks to expand the clinical applications for the use of its hydrogel technology.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The Evolut ™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access
The study was an analysis of AstraZeneca’s Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF). The patient data from the trial was processed with Brainomix’s e-Lung tool. The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
“Since the algorithm for matching patients with donors is changing across for all organs, this was a prime time to better understand whether transplant team decisions to accept a donated organ varied by patient race and gender,” she said. “We wanted to understand how the process of receiving a transplant after listing varied by race and gender, and the combination of the two, so that steps can be taken to make that process more equitable," said Khadijah Breathett, MD.
The Mount Sinai study found that primary care physicians’ approach reflects a dearth of evidence-based guidance for lung cancer screening shared decision-making in patients with complex comorbidities
This is the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.

By using this website you agree to accept Medical Device News Magazine Privacy Policy