Boston Scientific has announced the limited launch of the enhanced ACURATE neo2 aortic valve system in Europe.
The new system uses transcatheter aortic valve implantation (TAVI) technology. It builds on the clinical performance of the original ACURATE neo platform.
Designed to restore function and normal blood flow through a severely narrowed aortic valve, the new valve system features annular sealing technology. It helps the device to conform to irregular, calcified anatomies and further reduce paravalvular regurgitation or leaking (PVL).
Moreover, the delivery system simplifies access to smaller and complex vessels at the entry site and enables highly accurate valve positioning.
Its top-down deployment mechanism enhances stable placement and release, ensuring better patient outcomes.
The ACURATE neo2 aortic valve system has an expanded indication for patients with aortic stenosis.
Patients who are considered suitable candidates for the therapy by their heart team, including a cardiac surgeon, can undergo the treatment using this, despite their age and risk level, the company noted.
Boston Scientific Interventional Cardiology president Joe Fitzgerald said: “We believe having this differentiated valve with the enhanced sealing technology will further drive favorable market experience and growth.
“Combined with the LOTUS Edge Aortic Valve System and SENTINEL Cerebral Protection System to protect the brain against the risk of TAVI-related stroke, the ACURATE neo2 valve represents the natural evolution of our complementary dual-valve TAVI toolkit that covers the needs of a wide range of patient cases.”
ACURATE neo2 CE-Mark study found that PVL rates for the ACURATE neo2 Valve System is lower compared to that of current generation ACURATE neo valve.
Boston Scientific executive vice-president and global chief medical officer Dr Ian Meredith said: “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.
“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.”
The ACURATE neo2 Aortic Valve System received CE Mark in April. The system is currently under ACURATE IDE clinical trial in the US and is not available for sale.
Last week, Boston Scientific signed an investment agreement with privately held medical device company Farapulse with an exclusive option for acquisition.