Medtronic is set to roll out its newest CoreValve product, a next-generation transcatheter aortic valve replacement (TAVR) system. Named Evolut R, the device has received CE certification in Europe. Initial implants had also been made under a pivotal U.S. clinical trial involving 250 patients across 25 centers.
Evolut R will be one of the most sophisticated technologies in the market, thanks to its two key advantages over other similar products. For one, it is considered a low-profile TAVR system, as a 14 French catheter can be used to deliver the heart valve.
The Evolut R’s diameter is only about 6mm, which is significantly smaller than most devices. It can therefore be used with or without a sheath. The second advantage is that the system can be retrieved and repositioned.
“It’s giving us a free do-over so that if we are not absolutely happy, then we can recapture the device, put it in a better spot or in the unlikely event that it doesn’t work completely for the patient, then you can remove the device altogether, whereas in the past it would have required an open heart procedure,” explained Dr. Matthew Williams, one of the study’s primary investigators and director of Interventional Cardiology and Structural Heart and chief of Adult Cardiac Surgery at NYU Langone Medical Center in New York City.
Plus, the Evolut R is designed to reduce the probability of paravalvular leak, a common complication resulting from TAVR procedures. “There are modifications to the actual stent frame in terms of the mechanics of the force on the device and how hard it pushes against the tissue as well as the skirt which is wrapped around the device,” said Williams. Williams performed the first Evolut R implant in September and called it “really exciting new technology.