BURLINGTON, Mass., June 12 /PRNewswire-FirstCall/ -- LeMaitre Vascular, Inc. 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.
LeMaitre Vascular, Inc.
CONTACT: Aaron Grossman, Investor Relations of LeMaitre Vascular Inc.,+1-781-221-2266
Web site: http://www.lemaitre.com/
