Medtronic Begins Trial for Pericardial Surgical Aortic Heart Valve

Minneapolis, Minn.-based Medtronic Inc. has begun an investigational pericardial surgical aortic heart valve trial called Perigon. It’s a global, prospective clinical trial evaluating an investigational surgical aortic heart valve made from bovine pericardial (cow heart) tissue that is intended to replace a diseased, damaged or malfunctioning native or prosthetic aortic valve. The valve was recently implanted in the first U.S. patient at the ProMedica Toledo Hospital in Toledo, Ohio. The investigational surgical aortic heart valve currently is only available for investigational use in the United States.

The new aortic valve, which is designed with a low profile and interior-mounted leaflets (which allow the passage of blood through the heart) to help lessen the risk of coronary obstruction, will be evaluated in the trial for its ease of implantation, durability and hemodynamic performance (blood flow). 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 innovative 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. “We look forward to confirming this through the results from this trial.”

Worldwide, approximately 300,000 people have been diagnosed with severe aortic stenosis or narrowing of the valve, which restricts blood flow to the body. Medtronic’s valve is the latest advancement in Medtronic`s portfolio of surgical aortic valves and represents the company’s continued commitment over more than 20 years to deliver aortic valve technologies to meet the varied needs of patients.

“As a global leader in surgical and transcatheter aortic valve technologies, Medtronic looks forward to gathering clinical insights about our newest heart valve,” said  Rhonda Robb, vice president and general manager of Heart Valve Therapies at Medtronic. “We are pleased with the progress of the trial thus far and the overall reception to this next-generation aortic valve.”

The Perigon Trial will study up to 650 patients at up to 40 sites in Europe, the U.S. and Canada.