Medtronic has announced that the FDA has approved the company’s self-expanding transcatheter aortic valve implantation (TAVI) system CoreValve Evolut for the management of intermediate-risk patients with aortic stenosis. The approval follows the presentation of the SURTAVI study at the 2017 American College of Cardiology Scientific Session (17–19 March, Washington, DC, USA).
The study showed that, at two years, there were no significant differences in the rate of all-cause mortality or disabling stroke between intermediate-risk patients undergoing TAVI with CoreValve/CoreValve Evolut R and those undergoing surgery.
It evaluated intermediate-risk patients and compared 863 TAVI patients treated with the CoreValve/Evolut R systems (STS: 4.4%) with 794 surgical patients (STS: 4.5%). The CoreValve Evolut platform met its primary endpoint of non-inferiority compared to surgery in all-cause mortality or disabling stroke (12.6% for TAVI vs. 14% for surgery). The platform was also associated with significantly better mean aortic valve gradients (7.8mmHg vs. 11.8mmHg; p<0.001) at two years. Surgery was associated with less aortic regurgitation, major vascular complications and need for permanent pacemaker implantation.
Michael Reardon (Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist DeBakey Heart & Vascular Center, Houston, USA), says: “As evidenced by the landmark SURTAVI trial, the CoreValve Evolut platform is well-suited for the intermediate-risk patient population due to its supra-annular design for unsurpassed haemodynamics, low rates of mortality and disabling stroke, earlier improvement in quality of life, fast functional recovery times and short hospital stays. It is important to consider that in the first 30 days, patients treated with TAVI showed functional improvements and lower rates of stroke than the surgical patients in the study.”
The FDA approval means that, like Edwards Lifesciences’ Sapien XT/Sapien 3 devices, the CoreValve Evolut platform can be used to treat intermediate-risk patients both in Europe (it received the CE mark for intermediate-risk patients last year) and in the USA.