Coronary Artery Bypass

FDA approves arterial vascular closure system

Published in Medical Letter on the CDC and FDA, August 15th, 2004

Sub-Q, Inc., a privately held vascular closure company, has received marketing approval from the U.S. Food and Drug Administration (FDA) for its SureStat Arterial Closure System. SureStat is the next generation of closure technology approved in the U.S. for the "extravascular" or outside the vessel closure of femoral arteries following diagnostic or interventional vascular procedures.

The SureStat device provides a unique approach to closing a vessel puncture. It is introduced "over-the-wire" and through the patient's procedural sheath, eliminating many steps in the vascular closure process. SureStat delivers T-Foam, an enhanced, resorbing hemostatic sponge, directly...

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Source: Medical Letter on the CDC and FDA (2004-08-15)

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