Medtronic announces approval of the Evolut PRO TAVR system in China to treat severe aortic stenosis.

As the first Medtronic self-expanding TAVR system approved in China, the Evolut PRO system approval is based on clinical data from more than 32,000 patients, which showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics (blood flow). Full commercial launch is anticipated in early calendar year 2022.

The Evolut PRO TAVR system is the next generation of the clinically proven supra-annular CoreValve Evolut R system that provides industry-leading hemodynamic performance. The recapturable and repositionable Evolut PRO valve features a self-expanding nitinol frame with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance.

"The clinical demand for treatment of severe aortic stenosis is expected to increase due to growth of the aging population in China, and we anticipate TAVR will soon be widely accepted in clinical practice given the low mortality/stroke rates and fast recovery times," said Prof. Runlin Gao, M.D., academician of the Chinese Academy of Engineering, and former president at Fuwai Hospital of Chinese Academy of Medical Science & Peking Union Medical College. "The Evolut PRO TAVR system has shown impressive clinical outcomes and I look forward to seeing it benefit more patients throughout China."

The approval is based on data from high- and extreme-risk patients across Medtronic-sponsored studies and real-world registries with the CoreValve Evolut TAVR platform. Implanted in more than 400,000 patients in 160 countries worldwide, the CoreValve Evolut TAVR platform has shown consistently low, single-digit gradients and large effective orifice areas that promote valve performance.