WEBSTER, Texas, June 2, 2011 /PRNewswire/ -- IDEV Technologies, Inc. (IDEV) today announced the completion of enrollment in the SUPERB Trial, an FDA-approved IDE trial evaluating the use of IDEV's SUPERA® stent system for treatment of peripheral artery disease in the superficial femoral artery (SFA). Enrollment was completed in May, making SUPERB one of the fastest enrolling SFA trials.
The trial is a prospective, single-arm study of 258 patients at 49 U.S. sites, led by national co-investigators Kenneth Rosenfield, M.D., of Massachusetts General Hospital in Boston and Lawrence Garcia, M.D., of Steward's St. Elizabeth's Medical Center of Boston. The study objective is to demonstrate safety and effectiveness of the SUPERA stent in treating obstructive disease in the SFA.
Dr. Rosenfield summarized, "We are excited to complete enrollment in this important trial, and will now focus our efforts on patient follow-up and analysis. Given the encouraging data we've seen from Europe for the SUPERA stent, and given the stent's outstanding mechanical properties, we are anxious to finalize our results. It has been a pleasure to work with the great team of researchers, coordinators, and support staff on this trial."
"Endovascular treatment of the SFA in particular has been problematic for the millions of patients suffering from PAD in the United States," added Dr. Garcia. "The unique radial strength and flexibility of the SUPERA stent's design may provide what has been needed to successfully treat this challenging vessel."
Dennis Donohoe, M.D., is IDEV's Chief Medical Officer and has served as a key liaison to the clinical site investigators throughout the trial. "Completing enrollment of more than 250 pivotal patients in less than two years is a significant achievement and reflects not only the caliber of our investigator teams but also their confidence in this stent. I congratulate the team and look forward to our continued collaboration."
"Completing enrollment in the SUPERB trial is a significant milestone, and reflects IDEV's ongoing commitment to clinical research," remarked IDEV's President and Chief Executive Officer Christopher M. Owens.
The SUPERA VERITAS Transhepatic Biliary System currently has 510(k) clearance in the U.S. for the palliative treatment of biliary strictures produced by malignant neoplasms. The SUPERB trial results will be used to support IDEV's pre-market approval (PMA) submission for an additional peripheral vascular indication.
About IDEV Technologies, Incorporated
IDEV Technologies, Incorporated (IDEV) is an innovator and developer of next generation medical devices for use in interventional radiology, vascular surgery and cardiology. IDEV's worldwide headquarters is located in Webster, Texas and its European headquarters is located in Beuningen, The Netherlands.
The SUPERB Trial (Comparison of the SUPERA PERipheral System to a Performance Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery) is an FDA-approved IDE trial to evaluate SUPERA in treating patients with obstructive superficial femoral artery (SFA) disease.
The SUPERA stent is currently indicated in the United States for the palliative treatment of biliary strictures produced by malignant neoplasms and in Europe, Canada and Australia for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use following failed percutaneous transluminal angioplasty (PTA).
For more information please visit www.idevmd.com.
Vice President Global Marketing
IDEV Technologies, Incorporated
SOURCE IDEV Technologies, Incorporated