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First Recombinant DNA-Based Suture Approved
TUESDAY, Feb. 13 (HealthDay News) -- The U.S. Food and Drug Administration has approved the TephaFlex absorbable suture, the first suture to use polymer material isolated from genetically modified bacteria.
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Recombinant DNA technology allows scientists to produce chemicals from modified bacteria that would be difficult or impossible to produce using standard industrial methods, the agency said.
Sutures are used to close surgical incisions or large cuts. TephaFlex and other absorbable sutures break down in the body after a period of time, sparing doctors and patients the task of removing the sutures manually.
In granting approval for the device to Cambridge, Mass.-based Tepha Inc., the agency said the company had proven that the sutures could be manufactured in "a consistent and safe manner."
But the agency said the sutures shouldn't be used in people allergic to the bacteria or the media used to grow the bacteria-based material.
-- Scott Roberts
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