ev3 Inc. Files PMA Application for FDA Approval of Pipeline Embolization Device
May 18 2010 - 5:00AM
ev3 Inc. (Nasdaq:EVVV), a global endovascular device company, today
announced that it has filed the final module of its Premarket
Approval (PMA) application with the U.S. Food and Drug
Administration (FDA) for the Pipeline™ Embolization Device. This
final module, containing a comprehensive review of the clinical
data, completes the PMA application to the FDA. Upon receipt
of the clinical module, the FDA begins its 45 day filing process as
the first step in the formal review of the PMA. The company
anticipates the FDA could schedule an advisory panel review
sometime later in the year.
"This PMA submission is an important milestone for ev3 and our
commitment to advance innovative technologies to treat
neurovascular disease," said Robert Palmisano, president and chief
executive officer of ev3. "We are very encouraged by the
positive clinical results seen to date outside the United States
for the Pipeline device in treating large, giant and wide-neck
aneurysms and look forward to working with the FDA to facilitate
the review and approval of this breakthrough endovascular
treatment, which we anticipate in
2011."
The PUFS (Pipeline for Uncoilable or Failed AneurysmS) study
enrolled and treated 108 patients at 10 centers in the U.S. and
Europe. PUFS is a single-arm study of large and giant,
wide-neck or fusiform aneurysms typically not coilable, with a
six-month safety and effectiveness endpoints.
Safe and effective treatment of large and giant, wide-neck or
non-saccular aneurysms remains a significant unmet clinical
need. Clinical experience suggests that the Pipeline
Embolization Device may represent a valuable alternative to current
endovascular or surgical treatment options for these types of
aneurysms. ev3 estimates that approximately one fourth of
worldwide aneurysm treatment procedures could be eligible for
treatment with flow diversion devices over the next five years,
translating into a market potential of approximately $350 million
in 2013.
About ev3 Inc.
Since its founding in 2000, ev3 has been dedicated to developing
breakthrough and clinically proven technologies for the
endovascular treatment of peripheral vascular and neurovascular
diseases. The company offers a comprehensive portfolio of
treatment options, including the primary interventional
technologies used today -- plaque excision systems, peripheral
angioplasty balloons, stents, embolic protection devices, liquid
embolics, embolization coils, flow diversion, thrombectomy
catheters and occlusion balloons. More information about the
company and its products can be found at http://www.ev3.net.
ev3, the ev3 logo and Pipeline are trademarks of ev3 Inc. and
its subsidiaries, registered in the U.S. and other
countries.
Forward-Looking Statements
Statements contained in this press release that relate to
future, not past, events are forward-looking statements under the
Private Securities Litigation Reform Act of
1995. Forward-looking statements often can be identified by
words such as "expect," "anticipate," "intend," "will," "may,"
"believe," "could," "continue," "future," "estimate," "outlook,"
"guidance," or the negative of these words, other words of similar
meaning or the use of future dates. Forward-looking statements
in this press release include the date we anticipate FDA approval
of the Pipeline Embolization Device and the estimated market
potential for the Pipeline Embolization
Device. Forward-looking statements by their nature address
matters that are, to different degrees,
uncertain. Uncertainties and risks may cause ev3's actual
results to be materially different than those expressed in or
implied by ev3's forward-looking statements. For ev3,
particular uncertainties and risks include, among others, the
timing of regulatory approvals and introduction of new products,
market acceptance of new products, success of clinical testing,
availability of third party reimbursement, impact of competitive
products and pricing, the effect of regulatory actions and the cost
and effect of changes in tax and other legislation. More
detailed information on these and additional factors that could
affect ev3's actual results are described in ev3's filings with the
Securities and Exchange Commission, including its most recent
annual report on Form 10-K. Except as required by law, ev3
undertakes no obligation to publicly update its forward-looking
statements.
CONTACT: ev3 Inc.
INVESTORS and MEDIA:
Julie Tracy, Sr. Vice President,
Chief Communications Officer
(949) 680-1375
jtracy@ev3.net
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