FDA Grants Marketing Clearance to ev3 for Protege(R) GPS(TM) Long Stents
22 10월 2004 - 12:47AM
PR Newswire (US)
FDA Grants Marketing Clearance to ev3 for Protege(R) GPS(TM) Long
Stents Longer-Length Stents Can Replace Use of Multiple Shorter
Stents, Reducing Risk of Complications PLYMOUTH, Minn., Oct. 21
/PRNewswire/ -- ev3(R) Inc., a privately held endovascular medical
device company, has received 510(k) marketing clearance from the
U.S. Food and Drug Administration for the use of the company's
Protege(R) GPS(TM) Nitinol Self-Expanding Long Stents to treat
malignant biliary strictures. These stents are used during a
minimally invasive procedure to open strictures and blockages. The
product will be available in the U.S. market in October. The
Protege GPS Long Stents is also expected to receive CE Mark
approval for use in Europe to treat biliary strictures and
peripheral vascular disease, including the iliac artery. "The
Protege GPS Long Stents broaden ev3's self-expanding stent product
line to address additional unmet clinical needs," said Jim Corbett,
ev3 president and chief executive officer. "With the introduction
of longer- length stents, ev3 now offers the widest range of
self-expanding stents." The new Protege GPS Long Stents will be
offered in lengths up to 150mm. Using one stent, rather than
several shorter stents, simplifies the placement procedure and
reduces the risk of complications. All ev3 Protege stents
incorporate proprietary design elements to ensure precise stent
placement and provide optimal visibility on x-rays. The Protege GPS
is made of nitinol, an alloy commonly used in stents. About ev3 ev3
Inc., privately held and based in Plymouth, Minnesota, was founded
in 2001. ev3 Inc. is a global medical device company that is
focused on innovative endovascular technologies for the minimally
invasive treatment of coronary, neurovascular, and peripheral
vascular diseases and disorders. In 2001, ev3 established a
strategic relationship with Micro Therapeutics, Inc. (NASDAQ:MTIX),
a leader in the market for catheter-based neurovascular devices.
ev3 Inc. and Micro Therapeutics, Inc., are majority owned by ev3
LLC, a private equity partnership organized by Warburg Pincus and
the Vertical Group, two of the most successful institutional
investors in the medical device industry. More information about
ev3 and its products can be found at http://www.ev3.net/ . ev3,
Protege, Protege GPS, SPIDER, SpideRX, X-SIZER, PLAATO, IntraCoil,
ParaMount, IntraStent, AqWire, Nitrex and GOOSE NECK are trademarks
of ev3 Inc. Micro Therapeutics, Sapphire, Onyx, and Echelon are
trademarks of Micro Therapeutics, Inc. DATASOURCE: ev3 Inc.
CONTACT: Cheryl Newell, CFO of ev3 Inc., +1-763-398-7000, , or
Nancy A. Johnson, (612) 455-1745, , or Marian Briggs,
+1-612-455-1742, , both of Padilla Speer Beardsley Web site:
http://www.ev3.net/
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