U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies' SUPERA Peripheral Stent Created by News on 3/18/2009 12:16:21 PM
IDEV Technologies Incorporated, (IDEV) an emerging leader in the development and marketing of minimally invasive technologies, announced today 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).
Novel Stent Platform Designed for Radial Strength, Flexibility
HOUSTON, March 18 /PRNewswire/ -- IDEV Technologies Incorporated, (IDEV) an emerging leader in the development and marketing of minimally invasive technologies, announced today 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 Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery), a prospective, single-arm trial of 258 subjects at up to 40 U.S. sites, will be led by national co-principal investigators
Kenneth Rosenfield, M.D., of Massachusetts General Hospital, Boston, MA and Lawrence Garcia, M.D., of Caritas St. Elizabeth's Medical Center, Boston, MA.
"The approval of this IDE marks a significant step forward toward understanding the potential benefits of the unique properties of the SUPERA stent," Dr. Rosenfeld said. "Members of the physician community have already shown a high level of interest in this novel stent platform and IDEV's commitment to generating prospective clinical data will help us demonstrate the promise of this device."
The objective of the trial is to demonstrate the safety and effectiveness of the SUPERA Interwoven Self-Expanding Nitinol Stent in treating subjects with obstructive SFA disease. SUPERA has demonstrated superior properties in engineering tests compared to nitinol laser cut slotted tube stents resulting in greater than four times the radial strength and 360 percent stronger crush resistance. The unprecedented increase in radial strength is due to the product's novel interwoven design, which adds strength without compromising flexibility. SUPERA also withstood more than 10,000,000 cycles of repeated bending - 120 degree flexion and compression loading fatigue testing, without a fracture.
"We believe SUPERA may prove to be a more durable solution and ultimately the gold standard for the treatment of PAD, a serious condition for millions of Americans and others around the world," said
Tom Tully, Chairman and CEO of IDEV Technologies. "We are excited to begin enrolling subjects into the SUPERB trial and look forward to compiling data that will demonstrate the effectiveness of its unique design."
About IDEV Technologies, Incorporated
IDEV Technologies, Incorporated (IDEV) is an innovator and developer of next generation medical devices for use in the interventional radiology, vascular surgery and cardiology device marketplace. IDEV is based in Houston, Texas.
Contact: Thomas M. Tully, Chairman and CEO
Christopher M. Owens, President and COO
John Dame, Director of Finance
IDEV Technologies Inc.
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