Medtronic's CoreValve Evolut Pro Transcatheter Valve Approved by FDA

March 23, 2017—Medtronic announced US Food and Drug Administration approval and the United States launch of its CoreValve Evolut Pro transcatheter valve system for the treatment of severe aortic stenosis in symptomatic patients who are at high or extreme risk for open heart surgery.

According to Medtronic, the Evolut Pro features an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. The biocompatible porcine pericardial tissue wrap, in addition to other design elements, addresses the occurrence of blood leaking through the sides of the valve.

The Evolut Pro system is indicated for vessels as small as 5.5 mm. It is delivered through the EnVeo R delivery catheter system and features an InLine sheath. The 23-, 26-, and 29-mm sizes of the Evolut Pro system are available for use in the United States. It is not available for use in countries outside of the United States.

The company stated that 30-day clinical data showed high survival, low rates of stroke, minimal paravalvular leak (PVL), and excellent hemodynamics for the self-expanding valve. The data were announced at ACC.17, the American College of Cardiology's 66th annual scientific session, which was held March 17–19 in Washington, DC.

John Forrest, MD, who presented the data at ACC.17, commented in Medtronic's announcement, "The 30-day clinical outcomes presented at ACC demonstrate the Evolut Pro valve to be an outstanding treatment option for patients with severe aortic stenosis who are at a high or extreme risk for surgery." Dr. Forrest is Assistant Professor of Medicine at Yale University School of Medicine in New Haven, Connecticut.

The Evolut Pro clinical study (N = 60) met its primary endpoint at 30 days with high rates of survival (98.3%) and low rates of disabling stroke (1.7%). The Evolut Pro valve also showed strong hemodynamic performance with large aortic valve areas (2.0 ± 0.5 cm²) and mean gradients in the single digits (6.4 ± 2.1 mm Hg) at 30 days. The majority of patients in the study (72.4%) experienced no/trace PVL, and no incidents of moderate or severe PVL were observed at 30 days. Additionally, the rate of new pacemaker implantation was 10%. which improved on the low rates seen in Evolut R clinical studies and real-world TVT and FORWARD registries.

Mathew Williams, MD, also commented in the company's announcement, "Based on my experience implanting the Evolut Pro valve during the clinical study, I've been impressed by the clinical outcomes achieved in our patients. This innovation represents an important advantage over previous generations of this device, as it can help assist with adequate sealing even in complex cases." Dr. Williams is Chief of Adult Cardiac Surgery and Director of Interventional Cardiology and the Heart Valve Program at the NYU Langone Medical Center in New York, New York.