CoreValve Evolut R System demonstrates benefits for aortic stenosis treatment- Medtronic

Medtronic has unveiled new clinical data showing that patients treated with the self-expanding CoreValve Evolut R System continued to experience excellent clinical outcomes at one year. As the first-and-only recapturable transcatheter aortic valve replacement (TAVR) technology commercially available in the United States, the Evolut R TAVR system demonstrated high rates of survival, low rates of stroke and excellent hemodynamics in the Evolut R U.S. Investigational Device Exemption (IDE) Study.

Data from the study showed that 241 patients deemed extreme and high risk with symptomatic severe aortic stenosis had high rates of survival (91.4 percent) and low rates of disabling stroke (5.1 percent) at one year. Additionally, initial use of the larger, first-of-its-kind Evolut R 34 mm valve resulted in no deaths, no strokes, no vascular complications and two pacemaker implants (13.3 percent) at 30 days.

Excellent hemodynamic performance was also observed with mean aortic gradients (a common method for measuring the restriction of blood flow through the aortic valve) in the single digits (9.0 � 4.8 mm Hg) at one year. There were no patients with severe paravalvular leak (PVL) and low rates of moderate PVL (3.7 percent, n=188). Importantly, no incidents of embolization or migration, valve dysfunction requiring repeat procedure, endocarditis or valve thrombosis were observed, and the pacemaker rate was 18.3 percent at one year. Data were presented at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting.