PLYMOUTH, Minn.--(BUSINESS WIRE)--ev3 Inc. (NASDAQ:EVVV) today announced it has received conditional IDE (Investigational Device Exemption) approval from the U.S. Food and Drug Administration (FDA) to study the use of its Protégé® EverFlex™ Self-Expanding Stent System (“EverFlex”) in the treatment of peripheral artery disease (PAD). The trial, called DURABILITY II, is designed to demonstrate the stent system’s long-term patency and fracture resistance in symptomatic patients with PAD in the superficial femoral and proximal popliteal arteries of the leg. The study will include 30 clinical trial sites across the United States.
