St. Jude Medical Completes European Enrollment in its Trifecta Stented Tissue Valve Trial

July 23, 2009 – St. Jude Medical Inc. this week said it completed enrollment in its European clinical trial to evaluate Trifecta, a stented pericardial tissue aortic valve.

The Trifecta clinical trial is a multicenter, prospective study, which enrolled 120 patients at six centers throughout Europe. The trial will evaluate the safety and efficacy of the Trifecta stented tissue valve. Efficacy will be determined by the valve’s hemodynamic performance at 12 months.

An estimated 500,000 people worldwide suffer from severe, symptomatic aortic stenosis, while approximately 170,000 patients worldwide undergo aortic tissue heart valve replacements annually. Aortic valve replacement is typically indicated for patients with aortic stenosis, a narrowing of the aortic valve, or aortic regurgitation, a condition in which the valve does not close properly, allowing blood to flow back into the left ventricle.

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