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FDA yesterday gave the thumbs up to Cambridge, MA-based Tepha, to market its TephaFLEX Absorbable Suture product in the U.S. TephaFLEX is the first device that the privately held firm developed from a new class of biopolymers derived from a recombinant DNA technology licensed from the Massachusetts Institute of Technology.
Through a number of corporate partnerships already established by Tepha - including ones with Aesculap AG, HemCon Medical Technologies, LifeCell Corporation (LIFC), NMT Medical (NMTI) and Tornier - this technology is being applied to a wide array of products such as sutures, surgical meshes for orthopedic and hernia repair, anti-adhesion films, hemostats, intra-cardiac devices, absorbable stents, ligament and tendon repair and replacement devices, embolization agents, and drug delivery systems.
The TephaFLEX Absorbable Suture boasts up to 50% greater tensile strength than currently marketed monofilament absorbable sutures. In addition to high strength, the product offers surgeons improved flexibility, good knot security, and prolonged strength retention when implanted.
Source: Med Tech Sentinel
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