PERIGON Pivotal Trial

Investigator: Michael Reardon, MD

Study Coordinator: Amber Jacobs

Status: Enrolling

ClinicalTrials.gov Number: NCT02088554

Phone: 713.441.3905

IRB Number: Pro00011411

Description

To evaluate the safety and effectiveness of the Model 400 bovine pericardial stented aortic bioprosthesis in a patient population undergoing surgical aortic valve replacement. The collected data will be used to support regulatory applications in seeking market approval for the valve in Europe (CE Mark), the United States, Canada and other geographies.
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