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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/