TUESDAY, Feb. 13 (HealthDay News) -- The U.S. Food and Drug Administration has approved a novel suture called the TephaFLEX Absorbable Suture, which is made using DNA technology. Tepha, Inc. of Cambridge, Mass., uses genetically engineered bacteria to make the polymer suture's raw material.
The suture will be regulated as a class II (moderate risk) device. The sutures should not be used in patients who are allergic to the cells or the growth media used to produce TephaFLEX.
In order to gain approval for marketing, the company was required to prove that the material could be manufactured safely and to a consistent standard, and provided data from laboratory and animal studies on the suture's chemical composition, biological safety and mechanical performance.
"The TephaFLEX Absorbable Suture is made from material that uses the latest DNA technology," said Daniel Schultz, M.D., 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."
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