News | December 11, 2014

Medtronic Begins Global Clinical Study of Investigational Pericardial Surgical Aortic Heart Valve

Low-profile device with interior-mounted leaflets will be implanted in 650 patients

Medtronic, PERIGON Pivotal Trial, pericardial surgical aortic heart valve

December 11, 2014 — Medtronic, Inc. announced it has initiated the PERIGON (PERIcardial SurGical AOrtic Valve ReplacemeNt) Pivotal Trial, a global, prospective clinical trial evaluating an investigational surgical aortic heart valve made from bovine pericardial (cow heart) tissue. The device is intended to replace a diseased, damaged or malfunctioning native or prosthetic aortic valve. It was recently implanted in the first United States patient at the ProMedica Toledo Hospital in Toledo, Ohio.

The new aortic valve is designed with a low profile and interior-mounted leaflets to help lessen the risk of coronary obstruction. It will be evaluated in the trial for its ease of implantation, durability and hemodynamic performance. In addition to replacing a diseased native aortic valve, the next-generation valve also is designed to allow for future transcatheter aortic valve-in-valve interventions.

“I am thrilled to be the first physician in the United States to implant this pericardial heart valve for patients with aortic stenosis. Based on my involvement in the trial, the valve’s new design makes it easy to implant, which may offer important advantages critical to long-term patient outcomes,” said Michael Moront, M.D., FACS, cardiovascular surgeon at the ProMedica Toledo Hospital in Toledo, Ohio. “We look forward to confirming this through the results from this trial.”

The PERIGON Trial will study up to 650 patients at up to 40 sites in Europe, the United States and Canada. The investigational surgical aortic heart valve currently is only available for investigational use in the United States.

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