SAN LUIS OBISPO, Calif.–(BUSINESS WIRE)–FzioMed, Inc. is
pleased to announce that it has received CE Mark approval to market DYNAVISC®
adhesion barrier gel in Europe for tendon and peripheral nerve surgery.
DYNAVISC is a clear, absorbable gel supplied ready-to-use in
a 1mL syringe. It is designed to coat tissues during tendon and peripheral
nerve surgery. DYNAVISC gel acts as a temporary, protective barrier that
separates tissues and reduces fibrosis and the formation of post-surgical
DYNAVISC was developed by FzioMed and is based on the Companys
world-leading anti-adhesion biomaterial technology.
Adhesions are internal bands of scar tissue that can develop
following surgery as the body attempts to heal. Adhesions tether tissues and
surfaces that are normally not connected, later causing pain, nerve compression
and impaired motion. Adhesions are a significant complication of many surgical
procedures and a prevalent cause of post-surgical morbidity.
“Well over a million procedures to repair tendons are
performed in the EU each year and one-third of traumatic injuries involve
damage to tendons and nerves,” said John Krelle, President & CEO of
FzioMed. “Adhesions can impact an otherwise successful procedure, leaving a
patient with pain and diminished quality of life.”
Adhesions in Tendon and Peripheral Nerve Surgery
Adhesions can form following tendon and peripheral nerve surgeries such as in
the hand (for nerve repair, carpal tunnel syndrome and Dupuytrens
contracture), foot, shoulder and knee. Adhesions bind tendons to each other and
to surrounding structures, inhibiting their normal gliding function.
Adhesions following flexor tendon surgery in the hand cause
diminished function and pain. Adhesions that tether nerves produce tension
which can lead to ischemia and further nerve injury. Despite surgical and
rehabilitation techniques to maximize function, postoperative adhesions remain
a serious problem. Use of an adhesion barrier gel such as DYNAVISC can reduce
adhesion formation and improve the outcome of tendon and peripheral nerve
DYNAVISC gel is intended to reduce fibrosis and formation of adhesions
following tendon and/or peripheral nerve surgery. DYNAVISC is applied to coat
tissue surfaces exposed during surgery. The gel remains at the site of
application for a period of time, providing a barrier to adhesion formation
during the healing process. DYNAVISC is bioabsorbable and supplied in a sterile
syringe with a flexible application for easy application.
FzioMed is a privately held medical device company developing
and commercializing absorbable, surgical biomaterials based on the company’s
patented science. FzioMed’s polymer technology is used in a variety of surgical
specialties including orthopedics, spine, tendon, peripheral nerve, gynecology,
aesthetics and general surgery. www.fziomed.com.
Posted by Sean Fenske, Editor-in-Chief, MDT