One-Year Data Affirm Performance of Medtronic's CoreValve Evolut R System

October 14, 2015—Medtronic plc announced that 1-year data from the Evolut R CE Study of the CoreValve Evolut R recapturable, self-expanding transcatheter aortic valve replacement (TAVR) system were presented by study investigator Ganesh Manoharan, MD, at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco, California. 

The Evolut R CE Study is a prospective, single-arm, multicenter study that enrolled 60 extreme-risk and high-risk patients at six centers in Australia, New Zealand, and the United Kingdom. The study demonstrated a low (6.7%) rate of all-cause mortality in extreme- and high-risk patients at 1-year follow-up; the 1-year stroke rate was also low at 3.4%. 

According to Medtronic, the data presented at TCT demonstrated strong hemodynamic performance, which may be attributed to the valve’s supra-annular design. Mean aortic gradients remained low in the single digits at 7.5 ± 2.7 mm Hg at 1 year. Rates of moderate or severe paravalvular leak remained low (3.4% at 30 days and 4.3% at 1 year). The device’s valve positioning accuracy is optimized by the device’s 1:1 response and controlled deployment. The permanent pacemaker implantation rate was low at 30 days (11.7%) and at 1 year (15.2%).

These data showed no incidents of valve dysfunction, procedural death, annular rupture, coronary occlusion, valve thrombosis, embolization, or conversion to surgery. Transfemoral access was possible in all but one patient in a population that included patients with smaller vessels (down to 5 mm).

In the company’s press release, Dr. Manoharan, commented “These data show that, even in a high- and extreme-risk patient population, the exceptional procedural outcomes experienced with Evolut R were maintained through 1 year, which indicates that this next-generation, recapturable technology delivers on its promise to advance TAVR outcomes for patients. The low rate of paravalvular leak and new pacemaker implantation suggest that the ability to recapture and reposition during deployment will play an important role in the evolution of TAVR technology.” Dr. Manoharan is a consultant cardiologist at the Royal Victoria Hospital in Belfast, Northern Ireland.

Medtronic advised that the 23-mm, 26-mm, and 29-mm sizes of the CoreValve Evolut R transcatheter valve and the CoreValve EnVeo R delivery catheter system are available in Europe and other countries that recognize the CE Mark. In June 2015, the CoreValve Evolut R system was approved by the US Food and Drug Administration for commercial use in the United States.