DUBLIN – September 23, 2019 – Medtronic plc (NYSE:MDT), a global leader in heart valve therapies, today announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Evolut™ PRO+ TAVR System – a new-generation Medtronic TAVR system that builds off the proven self-expanding, supra-annular Evolut TAVR platform. The Evolut PRO+ TAVR System includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for the largest indicated patient treatment range and the lowest delivery profile currently on the market. The launch comes on the heels of the FDA’s recent indication expansion for the Evolut TAVR platform to treat patients with symptomatic severe aortic stenosis at a low risk of surgical mortality, the final surgical risk category to be approved for TAVR.

“As TAVR becomes a preferred treatment option for more patients with severe aortic stenosis, it’s critically important to have valve technology available that keeps pace with the evolution of the therapy,” said Mathew R. Williams, M.D., director of the Heart Valve Program at the NYU Langone Health in New York City. “Valve technologies that are designed to help minimize paravalvular leak, simplify the valve delivery during the procedure, and for unobstructed blood flow are factors that have made TAVR an excellent choice for many patients.

The Evolut PRO+ TAVR System can treat the broadest annulus range and offers the lowest delivery profile on the market (the 23, 26- and 29-mm valves can treat vessels down to 5.0 mm). It features four valve sizes – including the 34 mm (treats vessels down to 6.0 mm) – with an external tissue wrap and an integrated, inline sheath, allowing physicians to treat patients with a range of anatomical variations. Consistent with the Evolut platform design, the PRO+ valve is designed with a self-expanding nitinol frame that conforms to the native annulus with consistent radial force and advanced sealing. The valve incorporates an outer porcine pericardial tissue wrap that adds surface area contact and tissue interaction between the valve and the native aortic annulus to help potentially reduce incidences of paravalvular leaks.

“Physicians are treating a broader range of patient anatomies than ever before – from large to small, from simple to complex,” said Guilherme Attizzani, M.D., interventional cardiologist and director Valve and Structural Heart Disease Center at University Hospitals in Cleveland. “Adding the external tissue wrap to the large 34mm valve size, which wasn’t previously available, is a major technological improvement that will benefit many patients with larger anatomies.”

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