Medtronic has secured approval from the US Food and Drug Administration (FDA) for its next-generation Evolut PRO+ TAVR system to treat symptomatic severe aortic stenosis patients.

The company has also commercially launched the new-generation TAVR system, which is developed based on the self-expanding and supra-annular Evolut TAVR platform.

Evolut PRO+ TAVR system details

The Evolut PRO+ TAVR system features four valve sizes with an external pericardial tissue wrap, which offers advanced sealing for the largest indicated patient treatment range.

The launch of the new system is based on the FDA’s recent indication expansion for the Evolut TAVR platform to treat patients with symptomatic severe aortic stenosis at low risk of surgical mortality. It is the final surgical risk category to be approved for TAVR.

Designed to treat the broadest annulus range, the Evolut PRO+ TAVR system is said to offer the lowest delivery profile on the market. Its 23mm, 26mm, and 29mm valves can treat vessels down to 5.0 mm, while the 34mm valve will treat vessels down to 6.0mm.

Evolut’s external tissue wrap and an integrated inline sheath will help physicians to treat patients with a range of anatomical variations.

The PRO+ valve is provided with a self-expanding nitinol frame, which conforms to the native annulus with consistent radial force and advanced sealing.

The valve integrates an outer porcine pericardial tissue wrap, which adds surface area contact and tissue interaction between the valve and the native aortic annulus to minimise incidences of paravalvular leaks.

Evolut TAVR platform, which includes Evolut R, Evolut PRO, and Evolut PRO+ TAVR systems, is used to treat symptomatic severe aortic stenosis patients across all risk categories in the US.

Medtronic cardiac and vascular group’s structural heart and cardiac surgery businesses chief medical officer and vice president Dr Pieter Kappetein said: “We anticipate the Evolut PRO+ TAVR System will help heart teams fine-tune their TAVR procedures, further building on the consistent and reliable outcomes that they have come to expect from the Evolut TAVR platform– including positive hemodynamic outcomes in part, due to its supra-annular valve design – which we continue to see with the Evolut platform across large-scale, randomised clinical trials.”

In August this year, Medtronic secured investigational approval from the FDA to start a pivotal trial for the assessment of new extended wear infusion set.