Medtronic (NYSE:MDT) said today that it’s following this month’s CE Mark nod for its CoreValve Evolut R replacement heart valve with a U.S. clinical trial of the device, a transcatheter aortic valve implant.
Fridley, Minn.-based Medtronic said the 1st U.S. patients enrolled in the trial were implanted with the Evolut R device, the latest iteration in the CoreValve TAVI line Medtronic acquired for $700 million plus milestones back in 2009.
The Evolut R version won CE Mark approval in the European Union earlier this month. The repositionable valve is designed to allow implanting physicians to return it to its EnVeo R delivery catheter and adjust its position as needed. The CoreValve Evolut R also uses Medtronic’s InLine sheath, which the company claims has the smallest profile on the market.
The prospective U.S. study is slated to enroll up to 250 patients at up to 25 sites, according to a press release. Primary endpoints are all-cause mortality and disabling stroke after 30 days and device success rate at 24 hours to seven days, with secondary endpoints including recapture success rate and hemodynamic performance, Medtronic 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," co-principal investigator Dr. Mathew Williams, of the NYU Langone Medical Center in New York City, said in prepared remarks.
"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," added Dr. Jeffrey Popma, of the Beth Israel Deaconess Medical Center in Boston, co-principal investigator in the pivotal U.S. trial of the CoreValve device. "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 [TAVI] therapy."