SYRACUSE, N.Y. — Dr. Ayman Iskander, an interventional cardiologist with SJH Cardiology Associates, on Aug.12 performed a heart procedure at St. Joseph’s Hospital Health Center that was part of a recently launched nationwide study.
The procedure was part of the Medtronic clinical trial for expanding the use of the CoreValve Evolut R System in low-risk, aortic-stenosis patients, St. Joseph’s said in a news release. Medtronic is a Minneapolis, Minnesota–based medical-technology company.
The Evolut R System is the “first and only,” next-generation, “recapturable, self-expanding” transcatheter aortic-valve replacement (TAVR) system commercially available in the U.S. for patients who are at a “high or extreme risk” for surgery, St. Joseph’s said.
St. Joseph’s is the only hospital in Central New York participating in this study, the organization added.
The procedure is for low-risk patients who require surgery for the treatment of aortic stenosis, which St. Joseph’s describes as a “narrowing of the aortic-valve opening.”
The system is designed to be “minimally invasive” while improving the re-sealing following the procedure, and “improving” blood flow and performance at the same time.
“This is [a U.S. Food and Drug Administration (FDA)]-approved procedure that has previously been limited only to high- and extreme-risk patients, but we are now able to start expanding it to mid- and low-risk patients,” Iskander said in the release. “It is a landmark trial that will be critical in changing the landscape of medical practice. And it is so impressive because these patients are often up and walking around a few hours after the procedure, as opposed to needing to stay in the [intensive-care unit] for several days.”
The valve is delivered through a new catheter-delivery system, which, at less than 1/5 inch, is the “smallest” in the market, St. Joseph’s said. The low profile enables treatment of patients with vessels down to 5 millimeters through the preferred transfemoral-access route, and may “minimize” the risk of major vascular complications in some patients, St. Joseph’s said.
The trial has a two-year endpoint and allows for a one-year analysis for early FDA submission.
Contact Reinhardt at ereinhardt@cnybj.com