Medtronic has successfully treated the first patient in its clinical trial, which is designed to evaluate the safety and effectiveness of the new CoreValve Evolut R System.
Around 250 patients with severe symptomatic aortic stenosis who are considered at high or extreme risk for open-heart surgical aortic valve replacement will be enrolled in the trial at up to 25 clinical sites in the US.
The new investigational self-expanding valve and 14FR equivalent delivery system provides new capabilities that are designed to advance deliverability and valve performance.
It also provides an option to recapture and reposition the CoreValve Evolut R valve during deployment, if needed, while performing transcatheter aortic valve replacement (TAVR).
NYU Langone Medical Center chief of Adult Cardiac Surgery, director of Interventional Cardiology and Structural Heart, and co-primary investigator for the trial Mathew Williams said: "In clinical trials and real-world use, patients treated with the current CoreValve System have experienced high rates of survival, low rates of stroke and improved quality of life.
"This study will build on that strong legacy by evaluating the next generation of this successful system, a recapture-enabled valve with the lowest-profile delivery system."
The trial’s primary endpoints are all-cause mortality and disabling stroke at 30 days, as well as device success rate at 24 hours to seven days, while the secondary endpoints include recapture success rate, when attempted, and haemodynamic (blood flow) performance.
The new system is comprises the CoreValve Evolut R transcatheter valve and the EnVeo R Delivery System. The company said that the new valve is anatomically designed to increase conformability at the annulus for optimal annular fit and sealing, as well as maintain supra-annular valve position for improved blood flow and hemodynamic performance.
The EnVeo R delivery system provides a new InLine Sheath which reduces the profile of the catheter shaft to 14 Fr equivalent.
Beth Israel Deaconess Medical Center director of Interventional Cardiology, Harvard Medical School professor of medicine and co-principal investigator of the original CoreValve US Pivotal Trial Dr Jeffrey Popma said: "The Evolut R System is designed to provide physicians with greater confidence throughout the procedure, and a back-up plan in case the valve isn’t positioned correctly at first.
"While the delivery system is designed to enable accurate positioning on the first attempt, the added assurance of recapturability to a commercially proven valve will be a significant advance for TAVR therapy."