Boston Scientific launches ACURATE neo2 aortic valve system in Europe

Boston Scientific announced Monday that it initiated a controlled launch in Europe of its ACURATE neo2 system, a next-generation transcatheter aortic valve implantation (TAVI) technology with a number of features that it says improve upon the clinical performance of the original platform. Compared to the previous model, the latest-generation system, which received the CE mark in April, also has an expanded indication for use in patients with aortic stenosis, regardless of age or risk level, who are considered appropriate candidates for the therapy.

Global chief medical officer Ian Meredith said ACURATE neo2 offers "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." He also noted that "the straightforward implant procedure enables physicians to reduce the length of time patients need to stay in the hospital, without compromising on safety and clinical results."

Reduced paravalvular leaking

According to Boston Scientific, the ACURATE neo2 valve system features a new annular sealing technology designed to conform to irregular, calcified anatomies and further minimise paravalvular regurgitation or leaking (PVL). Additionally, the delivery system "simplifies access to smaller and complex vessels at the entry site and allows for highly accurate valve positioning," the company said, adding that the "top-down deployment mechanism further supports stable placement and release to ensure the best patient outcomes."

Data from the ACURATE neo2 CE-mark study demonstrated PVL rates for the system to be lower than previously reported with the current generation ACURATE neo valve. At 30 days and one year after implantation, 97% and 97.5% of patients, respectively, experienced no/trace to mild PVL. The remainder experienced moderate PVL and there were no severe cases.

Investigational device in US

Boston Scientific gained the original ACURATE neo device, which was CE-marked in 2014, through its 2017 acquisition of Symetis for $435 million. Meanwhile, in the US, the ACURATE neo2 valve system remains an investigational device being assessed in the ACURATE IDE clinical trial.

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