Angiology
U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies' SUPERA Peripheral Stent
Published in Medical Letter on the CDC and FDA, April 5th, 2009
IDEV Technologies Incorporated, (IDEV) an emerging leader in the development and marketing of minimally invasive technologies, announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for a multi-center clinical trial of its SUPERA stent, a novel stent platform designed for the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA). PAD affects more than 8 million people in the U.S. alone and, by the age of 65, 12-20 percent of the population will develop PAD, according to the American Heart Association.
The SUPERB trial (Comparison of the SUPERA PERipheral System to a Performance...
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