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The first suture material based on recombinant DNA technology has been approved by the Food and Drug Administration (FDA). The TephaFLEX Absorbable Suture is made from material isolated from bacteria via a process that induces living organisms to create chemicals that would be tough to produce with standard industrial methods. The FDA approval was granted under the de novo petition process, which is a less rigorous process designed to help novel, lower-risk products get to market faster.
The new sutures aren't for patients who are allergic to the cells or the growth medium used to produce them. For more information, visit the manufacturer's Web site at http://www.tepha.com.
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