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.
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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
