Boston Scientific said that the ACURATE neo2 Aortic Valve System delivered a high procedural success rate of 98.4% and low rates of paravalvular leak (PVL) and mortality in a post-market study.

The findings are part of the first results from the ACURATE neo2 post market clinical follow-up (PMCF) study that is assessing the performance of the aortic valve system.

Boston Scientific said that the primary safety endpoint of all-cause mortality stood at 0.8% at 30 days in the single-arm European study.

As per the data, it was shown that none of the patients had greater than moderate PVL, while 1.9% of them experienced moderate paravalvular leak, 18.9% had mild paravalvular leak.

Boston Scientific also revealed that a key finding from the study was demonstrating a low rate of 6.5% of new pacemaker implantation 30 days after procedure, without any events of disabling stroke or acute kidney injury.

Ian Meredith — Boston Scientific global chief medical officer said: “These trial data confirm the success of meaningful and differentiated enhancements included in the design of the ACURATE neo2 valve, from low rates of PVL and first-time pacemaker implantation to excellent hemodynamic performance and high rates of procedural success and safety.

“We look forward to reviewing longer-term results from this trial and bringing this differentiated TAVR technology to more patients and their physicians.”

The ACURATE neo2 PMCF study features 250 patients having severe aortic stenosis. The study is being held across 18 European centres and will evaluate outcomes for five years after the procedure.

The study also has a primary imaging endpoint for evaluating the visually apparent thickening of the prosthetic valve leaflets (HALT).

In 2020, the ACURATE neo2 Aortic Valve System secured CE Mark.

Boston Scientific is assessed the device in the presently enrolling ACURATE IDE trial in the US and Canada.

  ACURATE neo2 Aortic Valve System, Boston Scientific, Europe, Ian Meredith, medical device industry news