Healthcare Industry News: nitinol stent
News Release - June 4, 2007
ev3 Receives Conditional IDE Approval to Study Use of Protege(R) EverFlex(TM) Self-Expanding Stent System in the Treatment of Peripheral Artery Disease
Trial Is First to Explore Single-Stent Treatment of Lesions as Long as 16 Centimeters and Fracture Resistance at Five YearsPLYMOUTH, Minn.--(HSMN NewsFeed)--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 Protege® EverFlex(TM) 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.
DURABILITY II will be the first trial in the treatment of PAD to explore single-stent treatment of lesions as long as 16 centimeters and will include rigorous, five-year follow-up on stent fracture. It also will be the first study to follow the Performance Goal design, which was developed by VIVA Physicians Inc. (VPI) and published in the March 2007 issue of Catheterization and Cardiovascular Interventions. Supported by the FDA, this design facilitates a single-arm study of bare nitinol stents in the superficial femoral and popliteal arteries.
"The management of PAD patients has been challenging and controversial to date, with limited high-quality data to demonstrate optimal treatment strategy," said Krishna Rocha-Singh, M.D., medical director, Prairie Vascular Institute, Springfield, Ill., the lead author of the Performance Goal article and co-principal investigator of DURABILITY II. "I expect that, with its novel approach, this trial will dramatically improve our knowledge and conviction regarding how best to treat this significant and often under-served patient population."
According to the American Heart Association, PAD affects 8 million Americans and is a significant cause of both morbidity and death. The EverFlex was designed specifically for use in the superficial femoral artery (SFA), where PAD is often present. It encompasses a unique spiral cell geometry constructed to withstand the extreme movement of the SFA, and in bench testing has been demonstrated to be five to ten times more durable than competitive stents.
"A significant percentage of SFA disease is diffuse, and therefore it is exciting to be able to study disease up to 16 centimeters with a single, non-overlapped stent such as the EverFlex," said Jon Matsumura, M.D., Northwestern University, Chicago, Ill., co-principal investigator. "This trial will gather important data to better understand the effectiveness of minimally invasive treatments for the many patients with often disabling symptoms of claudication."
The EverFlex stent has been available in the United States since February 2006 for the palliative treatment of malignant neoplasms in the biliary tree. ev3 is conducting its DURABILITY II trial with the objective of expanding the product's U.S. indication to include treatment of PAD.
"We expect that DURABILITY II will not only demonstrate the value of ev3's stent technology, but it will also be a key step in advancing the treatment of PAD," stated Jim Corbett, president and CEO of ev3. "We are very grateful for the collaboration of both the VIVA Physicians Group and FDA, both of whom were instrumental in allowing this groundbreaking trial design to move forward."
About ev3 Inc.
ev3 Inc. is a global medical device company focused on endovascular technologies for the minimally invasive treatment of vascular diseases and disorders.
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 forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied. Such potential risks and uncertainties relate, but are not limited to, in no particular order: product demand and market acceptance; the impact of competitive products and pricing; delays in regulatory approvals and the introduction of new products; and success of clinical testing. More detailed information on these and additional factors which could affect ev3 Inc.'s operating and financial results is described in the company's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K. ev3 Inc. urges all interested parties to read this report to gain a better understanding of the many business and other risks that the company faces. Additionally, ev3 Inc. undertakes no obligation to publicly release the results of any revisions to these forward-looking statements, which may be made to reflect events or circumstances occurring after the date hereof or to reflect the occurrence of unanticipated events.
ev3 and the ev3 logo are trademarks of ev3 Inc., registered in the U.S. and other countries.
All trademarks and tradenames referred to in this press release are the property of their respective owners.
Protege is a registered trademark of ev3 Inc.
EverFlex is a trademark of ev3 Inc.
Source: ev3
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