Australia approves Fziomed’s new viscoelastic gel

FzioMed, a privately held medical device company based in San Luis Obispo, CA., is pleased to announce the inclusion of Dynavisc on the Australian Register of Therapeutic Goods (ARTG). Dynavisc is an absorbable, clear, viscoelastic gel that is applied to tendons and peripheral nerves to reduce fibrosis and the formation of adhesions following surgery.

“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”

Dynavisc received a CE mark in January 2012 and is sold in the EU through independent distributors. Dynavisc, is a sister product to *Oxiplex® and Medishield™ (distributed by Medtronic), which have been marketed for more than ten years in 70 countries to reduce the incidence of adhesions and for the reduction of pain after spine surgery.

"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," said John Krelle, President and CEO of FzioMed.

*Oxiplex is not yet approved in the United States despite having demonstrated safety and effectiveness in clinical studies involving more than 500 patients. A Citizen Petition under 21 CFR 10.33 is still under review by FDA. 

Source:

FzioMed

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