Boston Scientific launches aortic valve system in Europe

Boston Scientific (NYSE:BSX) announced today that it began a controlled launch of its Acurate neo2 aortic valve system in Europe.
Marlborough, Mass.-based Boston Scientific’s next-generation transcatheter aortic valve implantation (TAVI) technology is designed to improve upon the original version of the Acurate neo platform.
Acurate neo2 has expanded indication for patients with aortic stenosis (with no specified age or risk level) who are considered appropriate candidates for the treatment by their heart team. The system restores function and normal blood flow through a severely narrowed aortic valve and includes new annular sealing technology for conforming to irregular, calcified anatomies.
The system’s annular sealing technology also minimizes paravalvular regurgitation or leaking (PVL) and offers access to smaller and more complex vessels at the entry site, allowing for accurate valve positioning while the top-down deployment mechanism further supports stable placement and release, according to a news release.
Acurate neo2 received CE Mark approval for commercialization in Europe in April, but remains unavailable for sale in the U.S. as it is in the midst of an FDA investigational device exemption clinical trial.