Medtronic’s Evolut PRO TAVR OK’ed in China

Medtronic gained National Medical Products Administration (NMPA) approval for its CoreValve Evolut PRO TAVR system to treat severe aortic stenosis for symptomatic patients in China at high or extreme risk for open heart surgery. It’s the first Medtronic self-expanding TAVR system approved in China. Commercial launch is anticipated early this year.
 
Evolut PRO TAVR is the next generation of the company’s supra-annular CoreValve Evolut R system. It features a self-expanding nitinol frame with an outer wrap that adds surface area contact between the valve and native aortic annulus, advancing valve sealing.
 
“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,” 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 told the press. “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 CoreValve Evolut TAVR Medtronic-sponsored studies and real-world registries. To date, it has been implanted in over 400,000 patients in 160 countries. It has shown consistently low, single-digit gradients and large effective orifice areas.
 
“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,” said Prof. Junbo Ge, MD, academician of the Chinese Academy of Sciences (Beijing) and director of the Department of Cardiology in Zhongshan Hospital affiliated to Fudan University in Shanghai. “Medtronic is a leader in the development of innovative TAVR technology with a strong track record of procedural safety and valve durability.”
 
Aortic stenosis currently affects over five million patients in China. The number is expected to rise to over seven million by 2030.
 
“We are excited to introduce the Medtronic supra-annular, self-expanding and recapturable TAVR platform to physicians and their patients in China as we look to expand access to our technology in new geographies,” said Nina Goodheart, president of Medtronic’s Structural Heart & Aortic business. “We have a tremendous opportunity to positively impact many patients with severe aortic stenosis in China.”