Fridley, Minn.-based Medtronic said the Perigon trial is slated to enroll as many as 650 patients at up to 40 sites in Europe, the U.S. and Canada. The study will examine Medtronic’s new surgical aortic valve implant, which is made from bovine pericardial tissue, the company said.
The 1st patient in the trial was recently implanted with the unnamed device at Toledo’s ProMedica Toledo Hospital. The trial is designed to evaluate the valve for ease of use, durability and hemodynamic performance, Medtronic said. And the SAVI valve is designed to allow for transcatheter aortic valve-in-valve procedures down the road, according to a press release.
"I am thrilled to be the 1st physician in the U.S. 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," Dr. Michael Moront said in prepared remarks. "We look forward to confirming this through the results from this trial."
"As a global leader in surgical and transcatheter aortic valve technologies, Medtronic looks forward to gathering clinical insights about our newest heart valve," added Medtronic heart valve therapies general manager Rhonda Robb. "We are pleased with the progress of the trial thus far and the overall reception to this next-generation aortic valve."