medisourceasia.com logo

Did You Know ?

 

About 
medisourceasia

Magazine
Industry News
Global Trends
Events Calendar
Web Links

Web Gallery

Advertising  Info

Contact

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)

*  *  *  *  *

Archives

more

Back | Back To Top