BURLINGTON, Mass., Nov. 27 /PRNewswire-FirstCall/ -- LeMaitre Vascular, Inc. announced today the enrollment of the 30th and final patient in the EndoFit Thoracic Stent Graft Clinical Study in China. The objective of this study, which commenced in August 2006, is to obtain clinical data in support of approval of the EndoFit Thoracic Stent Graft from the Chinese State Food and Drug Administration (SFDA). This begins a six-month follow-up and observation period after which submission will be filed.
Dr. Weiguo Fu, Director of the Endovascular Department of China Fudan University Zhongshan Hospital stated, “The radial force of the proximal end of the EndoFit Thoracic Stent Graft seems superior, as we have not seen any migration post implantation. Also, the flexibility of the delivery sheath allows for a controllable delivery around the aortic arch.” Dr. Fu works under Dr. Yugi Wang’s leadership and is participating is the study alongside Dr. Wei Guo of Beijing 301 Hospital and Dr. Shangdong Xu of Beijing Anzhen Hospital. George W. LeMaitre, Chairman, President and CEO, stated, “We are pleased to achieve a key regulatory milestone in this rapidly emerging endovascular device market.”
The EndoFit Thoracic Stent Graft is used to treat aortic aneurysms, a weakening and ballooning of the aorta. 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 EndoFit Thoracic 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, including, but not limited to the timing of LeMaitre Vascular’s proposed regulatory submission to the SFDA and the possibility of receiving approval for the sale of the EndoFit Thoracic Stent Graft in China. 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 EndoFit Thoracic Stent Graft Clinical Study in China will be unfavorable; the risk that these results, even if favorable, will not be accepted by the SFDA 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 EndoFit Thoracic Stent Graft in China if the device is approved for use in China; risks associated with doing business in China, including the risk of adverse changes on political, legal and economic policies of the Chinese government, risks associated with the Company’s protection and enforcement of its patents and proprietary rights in China; and other risk factors that are discussed in LeMaitre Vascular’s Final Prospectus 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.
CONTACT: Aaron Grossman Office: 781.221.2266 Investor Relations LeMaitre Vascular, Inc.
LeMaitre Vascular, Inc.
CONTACT: Aaron Grossman, Investor Relations of LeMaitre Vascular, Inc.,+1-781-221-2266
Web site: http://www.lemaitre.com/
