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Aneurysm

LeMaitre Vascular Receives IDE Approval to Begin the 'Unite' UniFit Abdominal Stent Graft Pivotal Study

Published in Gastroenterology Week, May 21st, 2007

LeMaitre Vascular, Inc. (NASDAQ:LMAT) 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...

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