Sapien 3 TAVR (transcatheter aortic valve replacement) is used in the treatment of patients suffering from severe, symptomatic aortic stenosis (AS) who are at high risk for or unable to undergo open-heart surgery.
According to a news release, the Sapien 3 TAVR valves are the most widely studied transcatheter valves, treating more than 30,000 patients in clinical trials across 65 different countries. The China Sapien 3 study supported the regulatory approval, having provided positive real-world results alongside three randomized controlled “Partner” studies.
Edwards offers the valve in 20mm, 23mm, 26mm and 29mm sizes for high-risk patients in China. The Irvine, Calif.-based company said that 650,000 patients worldwide have benefitted from TAVR to date.
“This approval marks a major milestone for Chinese physicians and their patients living with severe AS in need of alternatives to open-heart surgery,” Edwards corporate VP of TAVR Larry Wood said in the release. “Edwards is proud to introduce this technology, which has demonstrated successful outcomes for patients worldwide, into China. We look forward to partnering with hospitals throughout China to introduce this therapy through our comprehensive, globally proven training program.”