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New Biopolymer Suture Cleared by FDA
Dr. Simon Williams, President and CEO of Tepha, stated, "We are delighted that the FDA has cleared the TephaFLEX Absorbable Suture, and determined that devices of this type will be regulated as class II (510k) devices. The Company's novel biopolymer technology can now be further applied to the development of a range of medical devices to meet unmet clinical needs."
TephaFLEX polymer is a member of a new class of biopolymers with mechanical and biological properties that are uniquely applicable to implantable medical devices when compared to conventional synthetic and biologically derived polymers. Compared to synthetic polymers such as polylactic acid (PLA) and polyglycolic acid (PGA), TephaFLEX material is tougher and more flexible with an absorption rate and degradation profile that are compatible with human tissue repair and replacement applications. However, unlike other biopolymers such as collagen and hyaluronate, TephaFLEX polymer is a thermoplastic and can be fabricated into virtually any shape or form -- including fibers, films, tubes, foams, textiles, microspheres, and molded constructs -- using a wide range of conventional melt and solvent processing techniques.
The TephaFLEX Absorbable Suture is engineered to be one of the strongest absorbable fibers known, offering up to 50% greater tensile strength than currently marketed monofilament absorbable sutures. In addition to high strength, the TephaFLEX Absorbable Suture also offers surgeons improved flexibility, good knot security, and prolonged strength retention when implanted.
The new class of biopolymers to which the TephaFLEX polymer belongs is a product of Tepha's patented recombinant DNA technology. This technology allows the Company to engineer materials with a range of biological and mechanical properties for specific tissue repair and replacement applications. After the repair process, the biopolymers degrade in the body to natural metabolites in a biocompatible, cell-friendly manner.
Professor Anthony Sinskey of the MIT Department of Biology, and a co- inventor of the recombinant DNA technology, commented: "This breakthrough technology will allow Tepha and its partners to progress beyond the constraints of traditional medical device materials to offer new solutions for the unmet needs of physicians and their patients."
Source: Tepha, Inc.