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.
“We are pleased to bring the latest iteration of Acurate technology to market, offering design improvements that further support procedural performance and optimal outcomes for patients with severe symptomatic aortic stenosis, from those with simple to the most challenging anatomies,” Boston Scientific executive VP & global chief medical officer Dr. Ian Meredith said in the release. “The straightforward implant procedure also enables physicians to reduce the length of time patients need to stay in the hospital, without compromising on safety and clinical results.”