MEDTRONIC COMPLETES ENROLLMENT OF VALOR CLINICAL TRIAL
Medtronic has completed patient enrollment for the VALOR (Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms) clinical trial, a study evaluating the safety and efficacy of its Talent thoracic stent graft system for the treatment of thoracic aortic diseases.
VALOR is a large thoracic stent graft study, with three arms and 359 patients at 40 clinical centers in the U.S. The prospective, nonrandomized, multicenter study has a primary endpoint comparing "all cause" mortality at 12 months for open surgical repair against minimally invasive endovascular stent treatment using the Talent stent graft system.
Medtronic will use the results of the VALOR trial for submission to the FDA for approval of the Talent thoracic stent graft system. Final VALOR trial results may be available in 2006. The Talent thoracic stent graft has been available outside the U.S. since 1997.
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