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About First Medical Device
Derived from New Class of Biopolymers : Absorbable Suture product
The TephaFLEX Absorbable Suture is the first medical device
derived from a new class of biopolymers that is the product of
patented recombinant DNA technology.
The 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, it also offers surgeons improved
flexibility, good knot security, and prolonged strength retention
when implanted.
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.
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 material has biological and mechanical properties that are
uniquely suited for implantable medical devices. A wide array of
medical device applications include :
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 FDA has cleared the TephaFLEX Absorbable Suture, and
determined that devices of this type will be regulated as class II
(510k) devices.
The novel biopolymer technology can now be further applied to the
development of a range of medical devices to meet unmet clinical
needs.
(http://compliancehome.com/news/FDA/10436.html)
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