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

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.

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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