The FDA has approved the TephaFLEX absorbable suture to be marketed in the United States. The suture is manufactured by Tepha Inc, Cambridge, Mass.
The absorbable polymer suture is made from material isolated from bacteria modified by recombinant DNA technology. This technology uses living organisms to create chemicals that may be more difficult to produce by standard industrial methods.
The FDA reviewed safety and effectiveness information for the device under the de novo petition process. De novo petitions were added under the FDA Modernization Act of 1997 to find a way for novel but less risky products to get marketed. As a result of its review, the FDA determined that products of this type will be regulated as class II (moderate-risk) devices.
The device is contraindicated in patients who are allergic to the cells or the growth media used to produce the absorbable polymeric material.
[www.fda.gov, February 12, 2007]