Medtronic’s Evolut Pro TAVR System Approved in China for Patients With Symptomatic Severe Aortic Stenosis

January 10, 2022—Medtronic announced that China’s National Medical Products Administration (NMPA) has approved the company’s CoreValve Evolut Pro transcatheter aortic valve replacement (TAVR) system for the treatment of severe aortic stenosis in symptomatic patients who are at high or extreme risk for open heart surgery. Full commercial launch in China is anticipated in early calendar year 2022.

According to Medtronic, the Evolut Pro TAVR system is the next generation of the supra-annular CoreValve Evolut R system. 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 company noted that NMPA approval of the Evolut Pro system is based on clinical data from more than 32,000 patients that showed high survival, low rates of stroke, minimal paravalvular leak, and excellent hemodynamics.

“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,” commented Professor Runlin Gao, MD, in Medtronic’s press release. “The Evolut Pro TAVR system has shown impressive clinical outcomes and I look forward to seeing it benefit more patients throughout China.”

Professor Junbo Ge, MD, added, “Given the advantages of a minimally invasive procedure and the potential for a quick recovery, TAVR is rapidly developing in China and has become a suitable option for many elderly patients. Medtronic is a leader in the development of innovative TAVR technology with a strong track record of procedural safety and valve durability.”

Prof. Gao is academician of the Chinese Academy of Engineering, and former president at Fuwai Hospital of Chinese Academy of Medical Science & Peking Union Medical College in Beijing, China. Prof. Ge is academician of the Chinese Academy of Sciences (Beijing) and director of the Department of Cardiology in Zhongshan Hospital affiliated to Fudan University in Shanghai, China.