LeMaitre Vascular Receives IDE Approval to Begin the 'Unite' UniFit Abdominal Stent Graft Pivotal Study
May 09 2007 - 3:36PM
PR Newswire (US)
BURLINGTON, Mass., May 9 /PRNewswire-FirstCall/ -- LeMaitre
Vascular, Inc. (NASDAQ:LMAT) today announced that it has received
approval from the United States Food and Drug Administration (FDA)
for an investigational device exemption (IDE) supplement to conduct
its UNITE Aorto-Uni-Iliac Stent Graft Clinical Trial. This pivotal
study will evaluate the safety and effectiveness of the company's
UniFit Abdominal Stent Graft in the treatment of aorto,
aorto-iliac, and/or iliac aneurysms. LeMaitre Vascular had
previously received conditional FDA approval for its IDE
supplement. "Although we had initiated two study sites based upon
conditional approval, many other hospitals, though eager to
participate, have been waiting for the FDA to remove conditions. We
expect that this new approval will help us drive enrollment through
a broad range of study sites," said George W. LeMaitre, the
company's Chairman, President and CEO. "We believe surgeons need a
singled-body aorto-uni-iliac stent graft to help combat aneurysmal
disease and we are excited to begin implanting devices in our
pivotal study." LeMaitre Vascular intends to enroll 90 patients in
up to 14 centers. These patients must be followed for at least one
year prior to LeMaitre Vascular's submission to the FDA of an
application for PMA approval. The primary effectiveness endpoint of
the study is based on aneurysm exclusion as evaluated through
one-year follow-up. The UNITE study compares the safety and
efficacy of the UniFit Abdominal Stent Graft against open surgical
abdominal aorta repair, because there are currently no
aorto-uni-iliac endovascular stent grafts indicated for the primary
treatment of aorto, aorto-iliac, and/or iliac aneurysms. The UniFit
Abdominal Stent Graft is a single-bodied aorto-uni-iliac stent
graft used to treat an aortic aneurysm, a weakening and ballooning
of the aorta, through a minimally invasive endovascular procedure.
The device's encapsulated design prevents its stents from
contacting the blood stream or the vessel wall. This design allows
a wider range of stent graft sizes, including tapered and custom
grafts, to fit a wider range of patient anatomies than many
competing products. The UniFit Abdominal Stent Graft is currently
sold in the European Union and a small number of other foreign
jurisdictions and is not available for sale in the United States.
The FDA's IDE approval applies only to the investigational use of
UniFit Abdominal Stent Grafts that have been sterilized with
ethylene oxide gas, a relatively common means of sterilizing
medical devices. LeMaitre Vascular also sterilizes its UniFit
Abdominal Stent Grafts sold outside the United States with hydrogen
peroxide, a newer and generally faster means of sterilizing medical
devices. Hydrogen peroxide sterilization enables the more rapid
production of customized stent grafts. LeMaitre Vascular intends to
continue to work with the FDA to resolve their questions regarding
this method of sterilization with the intent of ultimately seeking
PMA approval of the hydrogen peroxide-sterilized UniFit Abdominal
Stent Graft. About LeMaitre Vascular LeMaitre Vascular develops,
manufactures and markets medical devices for the treatment of
peripheral vascular disease. The company's principal executive
offices are located at 63 Second Avenue, Burlington, Massachusetts
01803. Certain statements set forth above that are not clearly
historical in nature are forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including, but not limited to the likelihood and timing of
enrollment in the UNITE study, the likelihood that the UNITE study
will successfully meet its endpoints, the possibility of receiving
approval for the sale of the UniFit Abdominal Stent Graft in the
Unites States, and the potential market demand in the United States
for the UniFit Abdominal Stent Graft. Although LeMaitre Vascular
believes that such statements are based on reasonable assumptions
within the bounds of its knowledge of its business and operations,
these forward-looking statements are neither promises nor
guarantees. LeMaitre Vascular's business is subject to significant
risks and uncertainties and there can be no assurance that its
actual results will not differ materially from its expectations.
These risks and uncertainties include, among others: the risk that
the results of LeMaitre Vascular's UNITE study will be unfavorable;
the risk that these results, even if favorable, will not be
accepted by the FDA or other relevant agencies and the device will
not be approved for sale in the relevant timeframe, if at all;
risks associated with LeMaitre Vascular's ability to successfully
commercialize its UniFit Abdominal Stent Graft in the United States
if the device is approved for use in the United States; and other
risk factors that are discussed in LeMaitre Vascular's Annual
Report on Form 10-K filed with the Securities and Exchange
Commission. The forward-looking statements made in this release are
made only as of the date hereof and LeMaitre Vascular disclaims any
intention or responsibility for updating predictions or
expectations contained in this release. DATASOURCE: LeMaitre
Vascular, Inc. CONTACT: Aaron Grossman, Investor Relations of
LeMaitre Vascular, Inc., Office: +1-781-221-2266 Web site:
http://www.lemaitre.com/
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