PLYMOUTH, Minn., Jan. 24 /PRNewswire-FirstCall/ -- ev3 Inc. (Nasdaq:
EVVV) today announced U.S. Food and Drug Administration approval of the
PROTEGE(R) RX Carotid Stent. This stent, when used in conjunction with the
ev3 embolic protection device, is indicated for the treatment of carotid
artery disease in patients who are at high-risk for adverse events from
carotid artery surgery. ev3's SpideRX(R) Embolic Protection Device was
previously FDA cleared for carotid use in February 2006.
(Logo: http://www.newscom.com/cgi-bin/prnh/20050615/CGEV3LOGO )
The FDA approval was supported by the CREATE (Carotid Revascularization
with ev3, Inc. Arterial Technology Evolution) Trial demonstrating the
safety and effectiveness of the PROTEGE(R) Stent and the SPIDER(TM) Embolic
Protection Device when used together to treat carotid artery disease
patients at risk for stroke and also at high-risk for adverse events from
surgery. The CREATE Trial enrolled 419 patients in 31 centers in a
prospective, non- randomized study. The results of the CREATE trial
compared favorably with performance criteria that were based on the results
of previous carotid stenting trials.
The PROTEGE(R) RX is available in both straight and tapered stent
configurations providing a variety of device options to address a broad
range of patient anatomy present in carotid artery disease. The "rapid
exchange" platform allows for a single physician to operate the device as
compared to "over the wire" designs that require multiple operators. The
SpideRX(R) Embolic Protection Device is the only available distal filter
embolic protection device that permits physicians to use their guidewire of
choice and is cleared by the FDA for use in both carotid arteries and
saphenous vein grafts.
Gary Ansel, M.D., Riverside Hospital, Columbus, Ohio, national co-
principal investigator for the CREATE Trial, stated, "The ev3 products used
in treating carotid disease offer unique features that make these products
ideally suited for carotid artery stenting. The PROTEGE(R) RX Carotid Stent
has an innovative delivery system that allows physicians to place the stent
accurately and also provides great visible confirmation due to its distinct
radiopaque markers. The SpideRX(R) Embolic Protection Device is unique
because it allows physicians to use any guidewire they choose to cross the
lesion just as they would in any other endovascular intervention."
Robert Safian, M.D., William Beaumont Hospital, Royal Oak, Mich.,
national co-principal investigator for the CREATE Trial, stated, "The
results of the CREATE Trial were comparable to other high-risk carotid
registries and provide additional evidence of the efficacy and safety of
carotid stenting to prevent stroke."
Carotid arteries, located on either side of the neck, are the main
blood vessels providing blood flow to the brain. When carotid arteries are
narrowed by atherosclerotic disease, patients are at risk for ischemic
stroke (a blockage of an artery in the brain by embolic particles). Stroke
is the third leading cause of death in the United States, affecting nearly
700,000 Americans each year, with approximately 30 percent of strokes being
caused by embolic debris that originates in diseased carotid arteries.
Traditionally, carotid artery disease has been treated with an open surgery
called endarterectomy. However, for the many patients who are at high risk
for surgery, carotid stenting has evolved as a viable option.
Jim Corbett, ev3's president and CEO, stated, "Obtaining FDA approval
and commencing commercialization of the PROTEGE(R) RX Carotid Stent, which
follows the previous clearance of the SpideRX(R) Embolic Protection Device
for use in treating carotid artery disease, are key milestones and evidence
ev3's continued commitment to the endovascular field. We believe that the
unique attributes of both the PROTEGE(R) RX and SpideRX(R) will permit ev3
to be a strong competitor in the carotid stenting market that we estimate
could reach $250 million worldwide in 2007."
In order to meet the growing requirements of a wide variety of
physician specialties, the PROTEGE(R) RX and the SpideRX(R) devices, which
are sold separately, will be represented by both the ev3 Cardio Peripheral
and Neurovascular sales organizations. In addition to the United States,
the PROTEGE(R) RX and the SpideRX(R) devices are commercially available in
Canada, Europe and several countries in Latin America and Asia.
About ev3 Inc.
ev3 is a global medical device company focused on catheter-based
technologies for the endovascular treatment of vascular diseases and
disorders. For more information, please visit http://www.ev3.net .
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 and annual report on Form 10-K. 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, PROTEGE RX, SPIDER, and SpideRX are
registered trademarks of ev3 Inc.
SOURCE ev3 Inc.
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Related links:
http://www.ev3.net
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20050615/CGEV3LOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
CONTACT:
Investor Relations, Patrick Spangler, CFO of
ev3, +1-763-398-7000, pspangler@ev3.net ; or Media, Laura Nobles
of Nobles Communications, +1-310-795-0497, fax, +1-310-338-8595,
laura@noblescommunications.com
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