July 20, 2011 — IDEV Technologies Inc. announced the completion of enrollment in the SUPERB trial, a U.S. Food and Drug Administration (FDA)-approved IDE trial evaluating the use of IDEV's Supera stent system for treatment of peripheral artery disease (PAD) 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 United States sites. It is 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.
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 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."
The Supera Veritas transhepatic biliary system currently has 510(k) clearance in the United States 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.
For more information: www.idevmd.com