IDEV Technologies announced patients’ enrolment completition 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.
The trial is a prospective, single-arm study of 258 patients at 49 US sites, led by national co-investigators Kenneth Rosenfield, Massachusetts General Hospital in Boston and Lawrence Garcia, Steward’s St. Elizabeth’s Medical Center of Boston. The objective of the study is to demonstrate safety and effectiveness of the Supera stent in treating obstructive disease in the superficial femoral artery.
“We are excited to complete enrolment in this important trial, and will now focus our efforts on patient follow-up and analysis. Given the encouraging data we have seen from Europe for the Supera stent, and given the stent’s outstanding mechanical properties, we are anxious to finalise our results. It has been a pleasure to work with the great team of researchers, coordinators, and support staff on this trial.” Rosenfield said.
“Endovascular treatment of the superficial femoral artery in particular has been problematic for the millions of patients suffering from peripheral artery disease 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, IDEV’s chief medical officer, has served as a key liaison to the clinical site investigators throughout the trial. “Completing enrolment 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.”