Medtronic’s Evolut PRO+ TAVI System Gains CE Mark

Medtronic obtained a CE mark for the Evolut PRO+ TAVI System, the company’s newest-generation TAVI system based on the self-expanding, supra-annular Evolut TAVI platform. Evolut PRO+ includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for the largest annular range (for self-expanding TAVI technology) on the market. The approval follows recent indication expansion for the Evolut platform in Europe for patients with severe aortic stenosis at a low risk of surgical mortality and patients with bicuspid aortic valves at intermediate, high, and extreme risk.
 
“As TAVI expands to a broader patient population, including patients at a low risk of surgical mortality and those with bicuspid valves, having the right valve technology becomes a critically important factor in making treatment decisions,” Haim Danenberg, M.D., Ph.D., professor of medicine and head of Interventional Cardiology at Wolfson Medical Center in Israel told the press. “Heart teams pursue a valve solution that is safe, effective and durable. We need a system that can be delivered through the femoral arteries without losing any feature of efficacy such as reducing paravalvular leak and achieving excellent hemodynamics. Because of its design and long track record of exceptional clinical outcomes, the Evolut TAVI platform is well-suited to meet these needs.”
 
Evolut PRO+ is approved in four valve sizes (the 23, 26, and 29mm systems can access vessels down to 5.0 mm), with the 34mm system able to access vessels down to 6.0 mm. The system has an outer porcine pericardial tissue wrap that adds surface area contact and tissue interaction between the valve and the native aortic annulus. This, combined with an integrated, inline sheath lets physicians to treat patients with a range of anatomical variations with a low delivery profile. The PRO+ valve has a self-expanding nitinol frame that conforms to the native annulus with consistent radial force and advanced sealing.
 
“Anatomical variations can present unique challenges and demand tailored transcatheter valve selection,” said Nicolas Van Mieghem , M.D., Ph.D., professor of interventional cardiology, department of cardiology, Thoraxcenter, Erasmus University Medical Center. “This is the first time European physicians will have access to the large 34mm Evolut PRO+ valve size that contains an external tissue wrap for patients with large aortic root dimensions.”
 
Severe aortic stenosis occurs when the aortic valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body and impacting daily activities. If left untreated, patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years.
 
“We believe that continued iteration of the CoreValve/Evolut family of supra-annular transcatheter aortic valves will result in progressive improvements in patient outcomes,” said Jeffrey J. Popma, M.D., vice president and chief medical officer for the Coronary & Renal Denervation business and the Structural Heart and Aortic business, which are part of the Cardiovascular Portfolio at Medtronic. “The Evolut PRO+ TAVI system will provide heart teams a valve with strong hemodynamic performance, with a lower vascular access profile, thereby allowing more patients to be treated by a transfemoral approach rather than alternative access methods. The additional pericardial wrap in the 34 mm Evolut PRO+ may also reduce the degree of residual perivalvular regurgitation.”