Tepha Corporate Partner, Aesculap AG, Introduces MonoMax(R) Monofilament Suture at the German Surgical Congress in Munich following Receipt of CE Mark
LEXINGTON, Mass., May 1 /PRNewswire/ -- Tepha, Inc., a developer of medical devices announced today that its corporate partner, Aesculap AG, has received a CE Mark and is launching its MonoMax monofilament absorbable suture for general surgical indications in Europe. The product is made with TephaFLEX(R) fiber, one of Tepha's new class of novel resorbable polyhydroxyalkanoate (PHA) polymers. The Tepha PHA polymer family is a product of the Company's patented recombinant DNA technology, which allows the engineering of resorbable medical devices with mechanical and biologic properties that are matched to specific tissue repair and replacement applications. MonoMax monofilament suture has longer strength retention than currently marketed resorbable sutures, and is more flexible. The product joins a strong portfolio of suture products from B. Braun Aesculap, currently at number two in share of the European suture market.
Miguel Pablo, Vice President Marketing & Sales and Regulatory Affairs Closure Technologies for the Aesculap Division stated, "B. Braun Aesculap is excited to be introducing this new technology into the European market for wound closure. We have been working with Tepha for several years to develop the MonoMax product line and believe Tepha's unique biomaterial will provide benefits to our customers and to their patients".
A clinical trial, the Multi-Center Study to Evaluate the Safety and Efficacy of Aesculap MonoMax for Abdominal Wall Closure or (ISSAAC), was recently concluded with positive results. The trial enrolled approximately 150 patients who were followed for twelve months after surgery. In the trial, the MonoMax suture was used for a continuous all-layer (except skin) suture to close abdominal wall after midline incision
|SOURCE Tepha, Inc.|
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