WASHINGTON, Feb. 12 (UPI) -- The U.S. Food and Drug Administration approved the use of sutures made from material isolated from bacteria modified by recombinant DNA technology.
The technology uses living organisms to create chemicals that may be more difficult to produce under standard industrial methods.
"The TephaFLEX Absorbable Suture is made from material that uses the latest DNA technology," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. "This approach could have broader applications for medical devices that use this novel manufacturing technology."
The FDA said it based its decision on the manufacturer's laboratory and animal testing that examined chemical composition, biological safety and mechanical performance of the polymeric suture. The product is produced by Tepha Inc. of Cambridge, Mass.
Doctors use sutures in patients to hold soft tissue together while the tissue heals from a deep cut or surgical incision. Absorbable sutures are made of materials that break down in the body after a short period of time.
The newly developed sutures are contraindicated in patients allergic to the cells or the growth media used to produce the absorbable polymeric material.
