PERIGON Pivotal Trial

Investigator: Michael Reardon, MD

Study Coordinator: Patricia Brinegar

Status: Enrolling Number: NCT02088554

Phone: 713.441.3506

Protocol Number: Pro00011411


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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