Boston Scientific broadened its reach in the transcatheter aortic valve implantation (TAVI) market with a controlled launch of Acurate Neo 2 in Europe. The Marlborough, MA-based company said the device first received CE mark in April.
The Acurate Neo 2 valve system also has an expanded indication for patients with aortic stenosis – with no specified age or risk level – who are considered appropriate candidates for the therapy by their heart team, including a cardiac surgeon.
"We believe having this differentiated valve with the enhanced sealing technology will further drive favorable market experience and growth," said Joe Fitzgerald, president, Interventional Cardiology, Boston Scientific. "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 Neo 2 valve represents the natural evolution of our complementary dual-valve TAVI toolkit that covers the needs of a wide range of patient cases."
Boston Scientific said data from the Acurate Neo 2 CE-Mark study showed at 30 days and 1 year after implantation, respectively, 97% and 97.5% of patients experienced ≤ no/trace or mild PVL, 3.0% and 2.5% of patients experienced moderate PVL and 0% of patients experienced severe PVL.
The device is not yet approved by FDA and is currently being evaluated in the ACURATE IDE trial in the U.S.
Boston Scientific gained access to Acurate when it closed its $435 million acquisition of Symetis.