VersaWrap nerve protector is an ultrathin, sutureless and bioresorbable hydrogel implant that enables to cover and protect peripheral nerves
The US FDA’s Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Commercial-stage medical device company Alafair Biosciences has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its VersaWrap nerve protector.
The VersaWrap nerve protector, which is similar to the VersaWrap tendon protector, is an ultrathin, sutureless and bioresorbable hydrogel implant that can be used to cover and protect peripheral nerves.
VersaWrap creates a permeable and gelatinous layer on or around the peripheral nerve to provide a non-constricting interface between nerve and surrounding tissues during healing.
It is designed to help in the efficient management of peripheral nerve injuries without significant loss of nerve tissue, said the company.
Alafair to seek approval for expanded applications of its hydrogel technology
Alafair is planning to make additional 510(k) filings to expand the clinical applications of its hydrogel technology.
Alafair Biosciences CEO Greg Brophy said: “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.
“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 organisation.”
Alafair Biosciences is involved in the development of novel clinical products by applying its patented hydrogel technology.
The company’s portfolio of 25 issued and 10 pending patents are said to cover a range of clinical applications.
In July this year, Ethicon, part of the Johnson & Johnson Medical Devices Companies, secured breakthrough device designation from the FDA for its NeuWave microwave ablation technology.
Enabled by the Monarch platform, the NeuWave microwave ablation system offers a minimally invasive option for soft tissue lesions.