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World Medical

This article was originally published in The Gray Sheet

Executive Summary

U.S. clinical trials for the Talent endoluminal stent graft system for treatment of thoracic aorta aneurysms begin under an approved investigational device exemption. The firm also is expanding by 150 patients its Phase II IDE study for the Talent for treatment of abdominal aortic aneurysms for patients with low to moderate surgical risk. Enrollment is nearly complete for a Phase II AAA study in the U.S. involving high-risk patients. Both versions of the device recently were CE marked for sale in the European Union. On April 10, the company entered a definitive agreement to be acquired by Arterial Vascular Engineering ("The Gray Sheet" April 20, p. 7)
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