Innovative Thermoplastic Absorbable Suture

A new absorbable polymer suture is made of a biomaterial similar to plastic that is isolated from bacteria modified by recombinant DNA technology.

The TephaFlex suture is based upon new methods for producing a class of natural materials called polyhydroxyalkanoate (PHA) polymers. However, unlike other naturally occurring biologic polymers, the PHA polymers are thermoplastic, and can be repeatedly softened with heat and hardened with cooling. The PHA polymers are biocompatible and non-inflammatory, and degrade by cell-friendly processes into metabolites that already exist in humans. Once inside the body, degradation rates of the PHA sutures can range from about six weeks to over a year; such prolonged strength retention is useful in sutures used in orthopedic procedures or in materials for ligament repair. The suture is contraindicated in patients allergic to the bacteria or to the growth media used to produce the absorbable polymeric material.

TephaFlex sutures are made by Tepha (Cambridge, MA, USA), and have been approved by the U.S. Food and Drug Administration (FDA). The company is also working on incorporating PHAs into a variety of implantable medical devices, such as artificial cardiac valves and vascular grafts. The monofilament polymer fibers can be processed into surgical textile products, as surgical meshes, non-woven felt, and other braided or knitted configurations.

"The TephaFlex Absorbable Suture is made from material that uses the latest DNA technology,” said Daniel Schultz, M.D., director of the center for devices and radiological health at the FDA. "This approach could have broader applications for medical devices that use this novel manufacturing technology.”

PHA polymers are synthesized in nature by numerous microorganisms, and have been recently recognized as the fifth class of naturally occurring biopolymers (along with the polyamino acids, polynucleic acids, polysaccharides, and polyisoprenoids).


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