Medtronic has treated the first US patient in a global, multicenter clinical trial, designed to compare the accuracy of its CoreValve system with surgical aortic valve replacement in treating patients with severe aortic stenosis and who are at intermediate risk to undergo open-heart surgery.
The CE marked CoreValve device, which is available in three sizes (26mm, 29mm and 31mm), is a transcatheter aortic valve implantation system approved for implantation via the transfemoral, subclavian or direct aortic approaches.
The randomized, controlled 2,500-patient CoreValve Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial has treated the first patient at Pinnacle Health System in Harrisburg, Pennsylvania, US
Based on the composite primary endpoint of all-cause mortality and disabling stroke at 24 months, the trial will evaluate whether the CoreValve system is non-inferior to surgical aortic valve replacement.
The company said all patients will be followed through five years.
The Methodist DeBakey Heart and Vascular Center Weill Cornell cardiothoracic surgery professor and study trial co-principal investigator Michael Reardon said that the trial will provide guidance to physicians who are looking for less invasive options for treating aortic stenosis.
"The Trial may demonstrate that the CoreValve System is beneficial to this broader population of patients who are looking for alternative treatments," Reardon added.