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FzioMed Receives Approval for Dynavisc® in Australia

2013年05月06日 PM07:25
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SAN LUIS OBISPO, Calif.

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.

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.

About FzioMed

FzioMed is a privately held medical device company founded in 1996. The company develops, manufactures and commercializes absorbable surgical biomaterials based on its patented polymer science. FzioMed adhesion barriers are used in many surgical applications including spine, orthopedics, hand, tendon, peripheral nerve, gynecology and general surgery. Its spine gel is the #1 adhesion barrier gel for spine surgery worldwide and is distributed by Medtronic, DePuy and other independent distributors. For more information, please visit www.fziomed.com.

FzioMed®, Dynavisc® and Oxiplex® are registered trademarks of FzioMed, Inc. MediShield™ is a trademark of Medtronic Sofamor Danek USA, Inc.

CONTACT

FzioMed, Inc.
John Krelle, 805-546-0610
CEO
and President

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