Medtronic 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 tissue that is intended to replace a diseased, damaged or malfunctioning native or prosthetic aortic valve. The PERIGON trial will study up to 650 patients at up to 40 sites in Europe, the U.S. and Canada.
The valve was recently implanted in the first US patient at the ProMedica Toledo Hospital in Toledo, Ohio. The investigational surgical aortic heart valve is currently only available for investigational use in the USA.
Designed with a low profile and interior-mounted leaflets to help lessen the risk of coronary obstruction, the new aortic valve will be evaluated in the trial for its ease of implantation, durability and haemodynamic 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 USA 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,” says Michael Moront, cardiovascular surgeon at the ProMedica Toledo Hospital in Toledo, Ohio. “We look forward to confirming this through the results from this trial.”
Worldwide, approximately 300,000 people have been diagnosed with severe aortic stenosis. The newly-designed heart valve is the latest advancement in Medtronic’s portfolio of surgical aortic valves. “Medtronic looks forward to gathering clinical insights about our newest heart valve,” says 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.”