US medical device company Boston Scientific announced its withdrawal from the heart valve business worldwide, citing increasing challenges in regulatory approvals in various countries. Boston Scientific's transcatheter aortic valve replacement (TAVR) heart valve ACURATE neo2 was approved in China last year. Industry insiders said that Boston Scientific's TAVR product failed to achieve the main goal of being non-inferior to other TAVR device products on the market. Boston Scientific said that the resources required to meet regulatory approval requirements prevented the company from further investment. With Boston Scientific's withdrawal from the market, the only major foreign companies competing in the TAVR market in China are Edwards Lifesciences and Medtronic; while domestic manufacturers occupy a larger market share.