Alafair Biosciences Receives FDA 510(k) Clearance for VersaWrap™ Tendon Protector
Austin, TX USA, June 13, 2016 – Alafair Biosciences Inc, an emerging medical device company, announced today that it received 510(k) clearance from the FDA to market and sell its tendon product, VersaWrap™ Tendon Protector, in the US. VersaWrap™ Tendon Protector is an ultrathin, sutureless, bioresorbable hydrogel that protects tendon gliding by separating injured tendon from surrounding tissues. Alafair will formally introduce the VersaWrap™ Tendon Protector to surgeons at the American Society for Surgery of the Hand meeting in Austin, TX.
The unique properties of VersaWrap™ Tendon Protector include an ultrathin profile allowing for application between tight tissues, a sutureless application eliminating the need for sutures or tissue glue, and device bioresorption following tendon healing.
“This ultrathin product gives surgeons the ability to protect tendon gliding in confined areas such as those found in upper extremity” says Brent Egeland, MD, a hand and plastic surgeon, “and the VersaWrap application procedure is sutureless, which makes it quick and easy to use.”
The VersaWrap™ Tendon Protector is the first product in the VersaWrap™ family of products to receive clearance and is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. “The FDA clearance of VersaWrap Tendon Protector is a significant milestone for Alafair and supports our commitment to develop and launch innovative products that meet the needs of surgeons and their patients,” says Daniel Peterson, MD, Alafair’s Chairman and CEO.
About VersaWrap™ Tendon Protector (VersaWrap™)
VersaWrap™ is an absorbable implant (device), designed to serve as an interface between the tendon or tendon sheath and the surrounding tissues, providing a non-constricting, protective encasement for injured tendons. VersaWrap™ consists of a sheet and a wetting solution. The VersaWrap™ sheet is comprised of non-animal derived hydrophilic polysaccharides. The VersaWrap sheet is easy to handle, can be cut to size, and is designed for placement on or around injured tendon. The sheet can be repositioned onto wet tissues as needed. Once positioned, the aqueous VersaWrap™ solution is applied to the sheet surface causing conformability and tissue adherence to underlying tissues.
VersaWrap™ is a non-inflammatory, non-toxic, non-irritating, terminally-sterilized, implantable hydrogel. It is supplied dry but hydrates immediately and can be implanted wet or dry. VersaWrap™ is designed to be applied to delicate, injured tendon tissue and tendon repairs.
About Alafair Biosciences Inc. (www.alafairbiosciences.com) develops surgical products for soft tissue repair and protection applications. Alafair will be launching VersaWrap™ Tendon Protector directly and through partnerships with some of the world’s major medical device companies.
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