Stents
First patient enrolled in carotid-stent clinical trial
Published in Medical Letter on the CDC and FDA, May 16th, 2004
The trial will team ev3's Protege Nitinol Self-Expanding Stent with the company's SPIDER Embolic Protection Device in a minimally invasive procedure to open blockages in carotid arteries and prevent strokes.
A total of 40 U.S. hospitals will participate in the trial and enroll approximately 420 patients who have blockages within their carotid arteries and are at high risk for an open surgical procedure. ev3 plans to submit trial data in an application to the U.S. Food and Drug Administration...
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