PLYMOUTH, Minn., March 9 /PRNewswire-FirstCall/ -- ev3 Inc. today announced U.S. Food and Drug Administration 510(k) clearance to market the PROTEGE EverFlex Self-Expanding Stent System for the palliative treatment of malignant neoplasms in the biliary tree. Additionally, ev3 obtained CE Mark for the PROTEGE EverFlex Self-Expanding Stent System for general use in the peripheral vasculature, including common and external iliac, subclavian and the superficial femoral artery. ev3 has already begun commercial release throughout Europe.
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The PROTEGE EverFlex Self-Expanding Stent System represents advancement in nitinol self-expanding stent technology, designed to provide previously undemonstrated durability in challenging clinical situations. In rigorous simulated fatigue testing, the PROTEGE EverFlex survived more than 5-20 times longer than any competitive stent tested.
"The new PROTEGE EverFlex Stent will be a valuable addition to my treatment options," commented Dr. Bob Smouse, Assistant Professor of Clinical Radiology and Surgery at the University of Illinois College of Medicine, Peoria, Illinois. "The stent design and fatigue data generated to date suggest that ev3 has made significant strides in addressing the clinical challenge of stent fracture."
In addition to providing a balance of strength and flexibility, the PROTEGE EverFlex provides similar delivery and deployment to the current PROTEGE stent family. Available on a 0.035" compatible delivery platform, the PROTEGE EverFlex also remains the longest self-expanding nitinol stent available worldwide, supplied in lengths up to 150mm. All sizes of the PROTEGE EverFlex will be compatible with a 6 French guiding catheter.
"Long stents have the potential to withstand forces better than multiple overlapping stents," said Dr. Dierk Scheinert, University of Leipzig Heart Center, Leipzig, Germany. "Through its combination of length and durability, I believe the PROTEGE EverFlex Stent System will enable treatment of more challenging lesions."
"We are pleased to provide this advance in stent technology to our customers. The PROTEGE EverFlex is an important part of ev3's goal of providing a broad variety of tools for endovascular procedures," stated James Corbett, President and CEO of ev3 Inc.
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, and success of clinical testing. More detailed information on these and additional factors which could affect ev3 Inc.'s operating and financial results are described in the company's filings with the Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q. ev3 Inc. urges all interested parties to read these reports 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 revision 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.
PROTEGE is a registered trademark of ev3 Inc.
EverFlex is a trademark of ev3 Inc.
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