PLYMOUTH, Minn., April 26, 2010 (GLOBE NEWSWIRE) -- 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."
About Peripheral Arterial Disease
Peripheral arterial disease -- or PAD -- occurs when leg arteries become narrowed or blocked by plaque. These blockages can result in severe pain for patients, limited physical mobility, and life-threatening non-healing leg ulcers. According to the American Heart Association, this condition affects approximately 8 to 12 million Americans. With only about 25 percent of PAD patients undergoing treatment, it is a disease that is largely under-diagnosed and under-treated. If left untreated, PAD can lead to critical leg ischemia, a condition where not enough blood is being delivered to the leg to keep the tissue alive. Total loss of circulation to the legs and feet can cause gangrene and lead to amputation.
About the EverFlex Stent System
The EverFlex System is a self-expanding nitinol stent, which incorporates a proprietary EX.P.R.T.™ Deployment Technology that secures the stent during delivery and facilitates smooth and consistent stent deployment. The EverFlex Stent System is cleared for palliative treatment of malignant neoplasms in the biliary tree in the U.S. and has the CE Mark for peripheral vascular use in Europe and many other countries.
About ev3 Inc.
Since its founding in 2000, ev3 has been dedicated to developing innovative and breakthrough technologies for the endovascular treatment of peripheral vascular and neurovascular diseases. The company offers a comprehensive portfolio of treatment options, including the primary interventional technologies used today -- plaque excision systems, peripheral angioplasty balloons, stents, embolic protection devices, liquid embolics, embolization coils, flow diversion, thrombectomy catheters and occlusion balloons. More information about the company and its products can be found at http://www.ev3.net.
ev3, the ev3 logo, EverFlex and EX.P.R.T. are trademarks of ev3 Inc., registered in the U.S. and other countries. All trademarks and trade names referred to in this press release are the property of their respective owners.
Forward Looking Statements
Statements contained in this press release that are not historical information are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the success, design, expected patient enrollment and other features of ev3's DURABILITY II trial, the efficacy, performance and success of the EverFlex Self-Expanding Stent System, future regulatory submissions and other statements identified by words such as "expect," "anticipate," "will," "plan," "may," "believe," "could," "outlook," "guidance," or words of similar meaning. Such forward-looking statements are based upon the current beliefs and expectations of ev3's management and are inherently subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied. Such potential risks and uncertainties include, but are not limited to, in no particular order: the success of clinical testing and new products, the timing and delays in regulatory submissions and approvals, the effect of other regulatory and legislative actions and introduction of new products and market acceptance of new products. More detailed information on these and additional factors which could affect ev3's operating and financial results is described in ev3's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K. ev3 urges all interested parties to read these reports to gain a better understanding of the many business and other risks that ev3 faces. Additionally, ev3 undertakes no obligation to publicly release the results of any revisions to these forward-looking statements to reflect events or circumstances occurring after the date hereof or to reflect the occurrence of unanticipated events.