Tepha Partner Launches Novel Monofilament Absorbable Suture Utilizing Tepha’s Proprietary Biomaterial
Tepha Corporate Partner, Aesculap AG, Introduces MonoMax(R) Monofilament Suture at the German Surgical Congress in
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 incisions. The primary objective of the trial was to demonstrate that the frequency of wound infection and the frequency of reoperation due to burst-abdomen after primary median laparotomy for elective surgical intervention are equal or lower than in previously reported clinical trials.
About Aesculap AG
Aesculap, a Tepha corporate partner since 2004, introduced the MonoMax product to customers at a symposium held in conjunction with the German Surgical Congress in
About Tepha, Inc.
Tepha, Inc, is a developer of medical devices derived from a new class of resorbable polymers that have been engineered utilizing recombinant DNA technology. The unique biologic and mechanical properties of the Tepha PHA polymers has been recognized by an expanding list of corporate partners that now includes Aesculap AG, ENTrigue Surgical, HemCon Medical Technologies, NMT Medical (Nasdaq: NMTI), and Tornier, Inc. Tepha received its first FDA 510(k) clearance for its TephaFLEX(R) Absorbable Suture in February, 2007 and the Company and its partners have now received six 510(k)’s covering a range of medical devices including sutures, meshes, and films.
For further information about Tepha, please contact
For further information about B. Braun Aesculap, please contact
SOURCE Tepha, Inc.