The new Evolut PRO+ TAVI system is launched in four-valve sizes with an external pericardial tissue wrap


Medtronic operational headquarters in Fridley, Minnesota, US. (Credit: Group29 at English Wikipedia)

Medtronic has secured CE mark approval for its Evolut PRO+ TAVI system to treat symptomatic severe aortic stenosis patients in Europe.

Based on the self-expanding and supra-annular Evolut TAVI platform, the new Evolut PRO+ TAVI system consists of four-valve sizes with an external pericardial tissue wrap that offers advanced sealing for the largest annular range on the market.

The latest approval is said to follow a recent indication expansion for the Evolut platform in Europe for patients with severe aortic stenosis.

The expanded indication covers those who are at a low risk of surgical mortality, as well as patients with bicuspid aortic valves who are at intermediate, high and extreme risk of surgical mortality.

According to Medtronic, Evolut PRO+ TAVI has secured approval for four value sizes, including 23mm, 26mm and 29mm systems that can access vessels down to 5.0mm and the 34mm system that can access vessels down to 6.0mm.

The system comes with an outer porcine pericardial tissue wrap that adds surface area contact and tissue interaction between the valve and the native aortic annulus.

In addition, it consists of an integrated and inline sheath, which will enable physicians to treat patients with a range of anatomical variations with a low delivery profile.

The PRO+ valve, which is in line with the Evolut platform design, is designed with self-expanding nitinol frame that aligns with the native annulus with consistent radial force and advanced sealing.

Medtronic cardiovascular portfolio’s structural heart and aortic business and the coronary and renal denervation business chief medical officer and vice president Dr 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 34 mm Evolut PRO+ may also reduce the degree of residual perivalvular regurgitation.”

The Evolut TAVR platform, which consists of Evolut R, Evolut PRO and Evolut PRO+ TAVI systems, is specified for symptomatic severe native aortic stenosis patients across all surgical risk categories in the US and countries that accept CE mark.

In March this year, Medtronic secured CE mark approval for its SenSight directional lead system for deep brain stimulation (DBS) therapy to treat symptoms associated with movement disorders and epilepsy.