Patient Enrollment Completed in DURABILITY II Study of ev3's EverFlex

April 26, 2010—ev3 Inc. (Plymouth, MN) announced the completion of patient enrollment in the DURABILITY II trial, a prospective, multicenter, 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 US Food and Drug Administration to obtain approval of the company's EverFlex self-expanding stent system for use in the SFA.

The DURABILITY II study enrolled a total of 287 patients at 44 centers in the United States 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 postintervention as compared to historical averages for balloon angioplasty.

According to the company, the DURABILITY II study is also the first to evaluate a 200-mm 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 Krishna Rocha-Singh, MD, co-National Principal Investigator of the study. “It's gratifying to offer my patients a therapy that may reduce the need for repeat interventions.”

The EverFlex system is a self-expanding nitinol stent that incorporates the company's EXPRT deployment technology, which secures the stent during delivery and facilitates smooth and consistent stent deployment. The EverFlex system is cleared for palliative treatment of malignant neoplasms in the biliary tree in the United States and is CE Mark-approved for peripheral vascular use in Europe and other countries.