Thirty-day results from a 120-patient trial backing a bid for CE Mark approval for the transcatheter aortic valve replacement, acquired for $435 million in May 2017, were presented at the annual PCR London Valves conference, Marlborough, Mass.-based Boston Scientific said.
Patients treated in the single-arm study showed a 97% rate of mild or less-than-mild paravalvular leakage and a procedural success rate of 97.5%, the company said. All-cause mortality (the primary safety endpoint) was 3.3% and the rate of disabling stroke was 1.7%. Of the 3% with more than mild PVL, no cases showed greater-than-moderate leakage, Boston said. Mean pressure gradients and effective orifice areas were 7.9 +/- 3.2mmHg and 1.7 cm2, respectively.
“We are very pleased with the initial performance of the Acurate Neo2 valve system and the low paravalvular regurgitation rates, lower than previously reported with Acurate neo, which can be attributed to the new advanced sealing technology,” global chief medical officer Dr. Ian Meredith said in prepared remarks. “Boston Scientific is committed to gathering clinical evidence that advances transcatheter heart valve therapies and expands our reach in patient care, especially in addressing unique patient pathologies and anatomies.”