ev3 completes enrollment in study of EverFlex Self-Expanding Stent System for SFA

ev3 Inc. (Nasdaq:EVVV) today announced the completion of patient enrollment in the DURABILITY II trial, a prospective, multi-center, single-arm study evaluating the EverFlex^® Self-Expanding Stent System for the treatment of superficial femoral artery (SFA) and proximal popliteal lesions. The DURABILITY II study will support a planned Premarket Approval (PMA) filing with the U.S. Food and Drug Administration to obtain approval of the EverFlex Self-Expanding Stent System for use in the SFA.        

"The DURABILITY II study is an important step in validating the performance of the EverFlex Self-Expanding Stent System in treating long, challenging lesions in the SFA," said Dr. Manish Mehta of the Institute for Vascular Health and Disease in Albany, NY and a participant in the trial. "Furthermore, based on its design, DURABILITY II will be a benchmark for device trials to obtain FDA approval." 

The DURABILITY II study enrolled a total of 287 patients at 44 centers in the U.S. and Europe and was the first to employ the Performance Goal developed by the VIVA Physicians, Inc. (VPI) to facilitate more rapid and rigorous evaluation of devices for vascular intervention.  The VPI Performance Goal allows evaluation of primary patency of the EverFlex stent at 12 months post-intervention as compared to historical averages for balloon angioplasty.  

The DURABILITY II study is also the first to evaluate a 200 mm length stent for use in treating peripheral arterial disease (PAD) in the legs.  "The ability to implant a single, long stent may lead to reduced fracture rates and improved durability of the implant," commented Dr. Krishna Rocha-Singh, Medical Director, Prairie Vascular Institute, and Co-National Principal Investigator of the study. "It's gratifying to offer my patients a therapy that may reduce the need for repeat interventions."

"With the high incidence of peripheral artery disease that occurs each year in the U.S., ev3 is committed to developing breakthrough therapies to treat this devastating disease," stated Robert Palmisano, ev3's President and Chief Executive Officer.  "We believe our EverFlex Self-Expanding Stent System will provide excellent and lasting clinical results as well as improved quality of life for individuals who suffer from PAD."