FzioMed, a US-based privately held medical device company, has included its Dynavisc on the Australian Register of Therapeutic Goods (ARTG).
Dynavisc is an absorbable, viscoelastic gel that is applied to tendons and peripheral nerves to reduce fibrosis and the formation of adhesions following surgery.
Dynaviscis is a sister product to Oxiplex and Medishield (distributed by Medtronic), which have been used to reduce the incidence of adhesions and pain after spine surgery.
FzioMed president and CEO John Krelle said, "Australia has proven to be a strong market for our products and adding a product for use in tendon and peripheral nerve surgery to our already successful spine and gynecology products, provides more protection for patients who suffer the debilitating effect of adhesions after surgery."
Oxiplex is not yet approved in the US despite having demonstrated safety and effectiveness in clinical studies involving more than 500 patients.