ev3 Inc. Announces First Patient Enrollments in DEFINITIVE LE Post-Market Study
Largest Study to Date Will Evaluate SilverHawk Plaque Excision System for Treatment of Lower Extremity Peripheral Arterial Disease
PLYMOUTH, Minn. (April 30, 2009) /PRNewswire/ — ev3 Inc. (NASDAQ: EVVV) today announced that the first patients were recently enrolled in the DEFINITIVE LE post-market study. DEFINITIVE LE is a prospective, multi-center, single-arm study to evaluate the intermediate and long-term effectiveness of stand-alone SilverHawk® Plaque Excision therapy for endovascular treatment of lower extremity peripheral arterial disease (PAD). Stuart Harlin, M.D., of Sacred Heart Hospital in Pensacola, Florida and Prakash Makam, M.D., of Community Hospital in Munster, Indiana enrolled the first two patients.
"The SilverHawk Plaque Excision System offers patients an effective and minimally-invasive treatment option for PAD, and I believe DEFINITIVE LE will validate the utility of plaque excision under real world conditions," said James McKinsey, M.D., Interim Chief of Vascular Surgery of New York Presbyterian Hospital System and the Universities of Columbia and Cornell, New York and co-principal investigator for the DEFINITIVE LE study.
The DEFINITIVE LE study results are expected to add to the growing body of data supporting SilverHawk therapy in patients with PAD. Up to 800 patients are expected to be enrolled from 50 clinical sites throughout the United States and Europe. The study will evaluate one-year patency in patients with leg pain (claudication) and one-year limb salvage in patients with critical leg ischemia (CLI) and include third party review of results by independent core-labs.
"As one of the most robust plaque excision studies to date, DEFINITIVE LE will provide much needed guidance on the treatment of PAD using plaque excision in both above- and below-the-knee applications," said co-principal investigator Lawrence Garcia, M.D., Chief of Interventional Cardiology and Associate Director of Vascular Medicine at St. Elizabeth's Medical Center, Boston. "Furthermore, this study will potentially add new insight on the optimal management of diabetic patients in this very difficult vascular territory."
Robert Palmisano, ev3's president and chief executive officer, stated, "ev3 has committed to advancing the science of peripheral artery disease treatment with a goal of making plaque excision a frontline therapy. We believe that the additional clinical data generated by our DEFINITIVE study series will provide evidence-based guidance to aid physicians in selecting optimal treatments for their patients, facilitate broader procedure adoption and establish SilverHawk plaque excision as an indispensable tool in combating PAD, a relentlessly progressive disease."
The DEFINITIVE Clinical Study Program
The DEFINITIVE LE study represents the second study in the company's DEFINITIVE clinical study program to confirm the value of plaque excision with the SilverHawk System. A U.S. IDE study, called DEFINITIVE Ca++, is currently underway to evaluate the use of the SilverHawk-R LSC (RockHawk) Plaque Excision System and the SpiderFX® Embolic Protection Device in the endovascular treatment of moderate to heavily calcified peripheral artery lesions. For information about the DEFINITIVE LE study and/or to locate physicians participating in the study, contact ev3 clinical affairs by phone at (763) 398-7203 or by email at firstname.lastname@example.org.
About Peripheral Artery Disease
Peripheral arterial disease (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 SilverHawk Plaque Excision System
The SilverHawk Plaque Excision System is a catheter-based technology used primarily by interventional cardiologists, radiologists, and vascular surgeons for the treatment of PAD. The device uses a small rotating blade to shave away plaque from inside the artery. As it is excised, the plaque collects in the tip of the device and then is removed from the patient, thereby restoring blood flow with minimal barotrauma and no permanent implant. Over 200,000 cases using the SilverHawk Plaque Excision System have been performed since the product first became available in 2003.
About ev3 Inc.
Since its founding in 2000, ev3 has been dedicated to developing innovative, breakthrough and clinically proven technologies and solutions for the treatment of peripheral vascular and neurovascular diseases. ev3's products are used by endovascular specialists to treat a wide range of peripheral vascular and neurovascular diseases and disorders. The company offers a comprehensive portfolio of treatment options, including the primary interventional technologies used today - peripheral angioplasty balloons, stents, plaque excision systems, embolic protection devices, liquid embolics, embolization coils, thrombectomy catheters and occlusion balloons. More information about the company and its products can be found at www.ev3.net.
ev3, the ev3 logo, SilverHawk and SpiderFX 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 DEFINITIVE LE and DEFINITIVE Ca++ trials, the efficacy, performance and success of the SilverHawk plaque excision system and SpiderFX embolic protection device, future regulatory submissions and other statements identified by words such as "expect," "anticipate," "will," "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, delays in regulatory approvals 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.