Medtronic has initiated CoreValve US pivotal clinical trial in the US.
The first CoreValve transcatheter aortic valve implantation (TAVI) procedure was performed by David Adams and Samin Sharma at The Mount Sinai Medical Center in New York City, Medtronic said.
The CoreValve System is designed with self-expandable technology to replace a diseased aortic valve percutaneously (through the skin), usually through the femoral artery, without open-heart surgery or surgical removal of the native valve.
The CoreValve device is delivered through a controlled deployment delivery system.
The Medtronic CoreValve System with the AccuTrak stability layer will be investigated in two independent studies, evaluating patients who have been deemed at high risk for aortic valve surgery, and those who have been deemed at extreme risk for aortic valve surgery (i.e. inoperable)
The CoreValveSystem will be investigated in more than 1,200 patients at up to 40 US clinical trial sites.
Interventional Cardiology at the Beth Israel Deaconess Medical Center in Boston, national co-principal investigator of the Medtronic CoreValve US pivotal trial and director Jeffrey Popma said that they are excited with this first step in bringing this important transformational therapy to patients in the US with life-threatening aortic valve disease, particularly those patients who have limited surgical options.