First Patient Implanted in UNITE Pivotal Study of LeMaitre Vascular's Unifit Abdominal Stent Graft
June 12 2007 - 1:18PM
PR Newswire (US)
BURLINGTON, Mass., June 12 /PRNewswire-FirstCall/ -- LeMaitre
Vascular, Inc. (NASDAQ:LMAT) today announced the first implant in
the UNITE Clinical Trial of its UniFit(TM) Abdominal Stent Graft.
The procedure was conducted at Emory University in Atlanta,
Georgia. The UNITE 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 intends to enroll 90 patients in up to 14 centers in
connection with the UNITE trial. These patients will be followed
for at least one year prior to LeMaitre Vascular's submission to
the FDA of an application for premarket approval (PMA), which is
prerequisite to commercial sale of the device in the United States.
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 this use. "We believe that surgeons need a
single-body aorto-uni-iliac stent graft to help combat aneurysmal
disease and we are pleased to have this first implant under our
belt," said George W. LeMaitre, the company's Chairman, President,
and CEO. 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 minimizes
the extent to which its stents contact the blood stream or the
vessel wall. This design also 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. 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. These statements include, but are not limited
to, those concerning enrollment in the UNITE study, the results of
the UNITE study, the possibility of receiving approval for the sale
of the UniFit Abdominal Stent Graft in the United 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.
There can be no assurance that the results of the UNITE trial will
support a PMA or that the FDA will approve the UniFit Abdominal
Stent Graft for sale the United States. 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.,
+1-781-221-2266 Web site: http://www.lemaitre.com/
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