ev3 Inc. Announces Completion of Patient Enrollment in DURABILITY II Study
April 26 2010 - 5:00AM
ev3 Inc. (Nasdaq:EVVV) today announced the completion of patient
enrollment in the DURABILITY II trial, a prospective, multi-center,
single-arm study evaluating the EverFlex
® Self-Expanding
Stent System for the treatment of superficial femoral artery (SFA)
and proximal popliteal lesions. The DURABILITY II study will
support a planned Premarket Approval (PMA) filing with the U.S.
Food and Drug Administration to obtain approval of the EverFlex
Self-Expanding Stent System for use in the
SFA.
"The DURABILITY II study is an important step in validating the
performance of the EverFlex Self-Expanding Stent System in treating
long, challenging lesions in the SFA," said Dr. Manish Mehta of the
Institute for Vascular Health and Disease in Albany, NY and a
participant in the trial. "Furthermore, based on its design,
DURABILITY II will be a benchmark for device trials to obtain FDA
approval."
The DURABILITY II study enrolled a total of 287 patients at 44
centers in the U.S. and Europe and was the first to employ the
Performance Goal developed by the VIVA Physicians, Inc. (VPI) to
facilitate more rapid and rigorous evaluation of devices for
vascular intervention. The VPI Performance Goal allows
evaluation of primary patency of the EverFlex stent at 12 months
post-intervention as compared to historical averages for balloon
angioplasty.
The DURABILITY II study is also the first to evaluate a 200 mm
length stent for use in treating peripheral arterial disease (PAD)
in the legs. "The ability to implant a single, long stent may
lead to reduced fracture rates and improved durability of the
implant," commented Dr. Krishna Rocha-Singh, Medical Director,
Prairie Vascular Institute, and Co-National Principal Investigator
of the study. "It's gratifying to offer my patients a therapy
that may reduce the need for repeat interventions."
"With the high incidence of peripheral artery disease that
occurs each year in the U.S., ev3 is committed to developing
breakthrough therapies to treat this devastating disease," stated
Robert Palmisano, ev3's President and Chief Executive Officer.
"We believe our EverFlex Self-Expanding Stent System will
provide excellent and lasting clinical results as well as improved
quality of life for individuals who suffer from
PAD."
About Peripheral Arterial Disease
Peripheral arterial disease -- or PAD -- occurs when leg
arteries become narrowed or blocked by plaque. These blockages
can result in severe pain for patients, limited physical mobility,
and life-threatening non-healing leg ulcers. According to the
American Heart Association, this condition affects approximately 8
to 12 million Americans. With only about 25 percent of PAD
patients undergoing treatment, it is a disease that is largely
under-diagnosed and under-treated. If left untreated, PAD can
lead to critical leg ischemia, a condition where not enough blood
is being delivered to the leg to keep the tissue alive. Total
loss of circulation to the legs and feet can cause gangrene and
lead to amputation.
About the EverFlex Stent System
The EverFlex System is a self-expanding nitinol stent, which
incorporates a proprietary EX.P.R.T.™ Deployment Technology
that secures the stent during delivery and facilitates smooth
and consistent stent deployment. The EverFlex Stent System is
cleared for palliative treatment of malignant neoplasms in the
biliary tree in the U.S. and has the CE Mark for peripheral
vascular use in Europe and many other countries.
About ev3 Inc.
Since its founding in 2000, ev3 has been dedicated to developing
innovative and breakthrough 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, EverFlex and EX.P.R.T. are trademarks of ev3
Inc., registered in the U.S. and other countries. All
trademarks and trade names referred to in this press release are
the property of their respective owners.
Forward Looking Statements
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 statements include, but are not limited to, statements
about the success, design, expected patient enrollment and other
features of ev3's DURABILITY II trial, the efficacy, performance
and success of the EverFlex Self-Expanding Stent System, future
regulatory submissions and other statements identified by words
such as "expect," "anticipate," "will," "plan," "may," "believe,"
"could," "outlook," "guidance," or words of similar
meaning. Such forward-looking statements are based upon the
current beliefs and expectations of ev3's management and are
inherently subject to risks and uncertainties that could cause
actual results to differ materially from those projected or
implied. Such potential risks and uncertainties include, but
are not limited to, in no particular order: the success of clinical
testing and new products, the timing and delays in regulatory
submissions and approvals, the effect of other regulatory and
legislative actions and introduction of new products and market
acceptance of new products. More detailed information on these
and additional factors which could affect ev3's operating and
financial results is described in ev3's filings with the Securities
and Exchange Commission, including its most recent annual report on
Form 10-K. ev3 urges all interested parties to read these
reports to gain a better understanding of the many business and
other risks that ev3 faces. Additionally, ev3 undertakes no
obligation to publicly release the results of any revisions to
these forward-looking statements to reflect events or circumstances
occurring after the date hereof or to reflect the occurrence of
unanticipated events.
CONTACT: ev3 Inc.
Investors and Media
Julie Tracy, Sr. Vice President, Chief Communications Officer
(949) 680-1375
jtracy@ev3.net
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