IDEV(R) Technologies, Incorporated, (IDEV) an emerging leader in the development and marketing of minimally invasive medical technologies, today announced that the first patient was enrolled in the Company's FDA-approved multi-center clinical trial of its self-expanding SUPERA(R) stent, a novel stent platform designed for the treatment of biliary and peripheral artery disease (PAD) in the superficial femoral artery (SFA). PAD of the lower extremities affects approximately 8 million-12 million people in the U.S. alone, according to the American Heart Association.
The clinical trial, called SUPERB (Comparison of the SUPERA PERipheral System to a Performance Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery), is a prospective, single-arm trial of 258 patients at up to 40 U.S. sites. It is led by national co-principal investigators Kenneth Rosenfield, M.D., Section Head for Vascular Medicine and Intervention at Massachusetts General Hospital, Boston, and Lawrence A. Garcia, M.D. Chief, Section Interventional Cardiology and Associate Director of Vascular Medicine at Boston's Caritas St. Elizabeth Medical Center, where the first patient was treated.
The objective of the trial is to demonstrate the safety and effectiveness of the SUPERA stent in the treatment of obstructive arterial disease in the superficial femoral artery of the lower extremity. The SUPERA Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary system received 510(k) clearance for palliative treatment of biliary strictures produced by malignant neoplasms and the SUPERA Interwoven Self-Expanding Nitinol Stent System received CE Mark approval in Europe for biliary and peripheral vascular indications.
"The SUPERA stent has unique properties that may be demonstrated on patients at facilities throughout the U.S.," Dr. Rosenfield said. "We believe this could prove to offer a significant advance in treating PAD and helping physicians treat the most difficult of blockages in a very large underserved patient population."