Medtronic has received CE Mark for its Evolut PRO+ TAVI System in Europe to treat patients with symptomatic severe aortic stenosis.
Based on the company’s self-expanding, supra-annular Evolut TAVI platform, the new system has four valve sizes with an outer pericardial tissue wrap. The wrap is said to offer advanced sealing for the largest annular range available in the market.
The approved valve sizes are 23, 26 and 29mm systems, which are able to access vessels down to 5mm, and a 34mm system, which can access vessels down to 6mm.
Evolut PRO+ TAVI System’s exterior porcine pericardial tissue wrap improves surface area contact and tissue interaction between the valve and native aortic annulus.
It also has an inline sheath that allows treatment of patients with various anatomical differences with a minimal delivery profile.
With a self-expanding nitinol frame, the PRO+ valve adapts to the innate annulus with steady radial force and improved sealing.
The latest approval comes after the Evolut platform obtained expanded indication in Europe for severe aortic stenosis patients with reduced surgical mortality risk and for those with bicuspid aortic valves who are at medium, high and extreme surgical mortality risk.
Medtronic coronary, renal denervation and structural heart business vice-president and chief medical officer Jeffrey Popma said: “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 34mm Evolut PRO+ may also reduce the degree of residual perivalvular regurgitation.”
In March, Medtronic received CE mark for its SenSight directional lead system for deep brain stimulation (DBS) therapy to treat symptoms linked to movement disorders and epilepsy.