Medtronic announced Monday, Jan. 10, that one of its self-expanding transcatheter aortic valve replacement (TAVR) solutions has been approved for the treatment of severe aortic stenosis in high-risk patients in China.
The company gained this approval for its CoreValve Evolut PRO TAVR system thanks to clinical data from more than 32,000 patients. This is Medtronic’s first self-expanding TAVR solution to gain such an approval from the National Medical Products Administration.
“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,” Nina Goodheart, president of Medtronic’s structural heart & aortic business, said in a statement. “We have a tremendous opportunity to positively impact many patients with severe aortic stenosis in China.”
“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,” added Runlin Gao, MD, a specialist from the Chinese Academy of Engineering. “The Evolut PRO TAVR system has shown impressive clinical outcomes and I look forward to seeing it benefit more patients throughout China.”
A full commercial launch is scheduled for the early part of 2022.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.