Boston Scientific is pulling its latest transcatheter aortic heart valve platform from the worldwide market and said it will no longer pursue an approval in the U.S., following recent stumbles in a clinical study.
In a filing with the SEC, the company said its decision to end sales follows new discussions with regulators about its Acurate neo2 implant and its successor, the Acurate Prime, “which resulted in increased clinical and regulatory requirements to maintain regulatory approvals in global markets and to obtain approvals in new regions”—and that the resources needed to satisfy those requirements would ultimately be cost-prohibitive.
It’s yet another setback for the company’s plans to break into the TAVR market, after it shuttered its previous Lotus Edge program in late 2020 following an international voluntary recall tied to the complexity of its delivery system.
Over the past five years, Acurate valves have been available in more than 50 countries and used to treat more than 80,000 patients—with the Acurate Prime obtaining an earlier-than-expected CE Mark approval in Europe last August. Boston Scientific also said last year that the continued commercial growth of Acurate neo2 on the continent had helped to carry its structural heart revenues to double-digit gains.
However, the company did not see the same success in a recent clinical trial. Last October, in a large, pivotal study aimed at clinching FDA approval, the Acurate neo2 failed to measure up to the two main TAVR systems on the market: Edwards Lifesciences’ Sapien 3 and Medtronic’s Evolut family.
Among 1,500 study participants with severe aortic stenosis at all risk levels for open surgery, Acurate neo2 reported a higher composite rate of all-cause deaths, strokes or rehospitalizations after one year—though Boston Scientific attributed the endpoint miss to about one-in-five of the valves not being fully expanded during their procedures.
This incorrect placement led to more turbulent blood flow through the implant, which in turn potentially drove the formation of heart attack- or stroke-causing clots in the months that followed, according to the study’s leaders. That pulled down the one-year results, while 30-day safety data had appeared on track.
The trial results were presented at the annual TCT conference last year as a late-breaking study, and were published earlier this month in The Lancet. Boston Scientific originally acquired the Acurate TAVR systems from its $435 million acquisition of the Swiss valve developer Symetis in 2017.
Boston Scientific said that, despite the financial impact of discontinuing the Acurate program, it expects to achieve its second-quarter and full-year sales goals, although it is not reaffirming its earnings-per-share projections. The company said it plans to provide more information on its next earnings call, which has not yet been scheduled.
Meanwhile, when it comes to the aortic valve’s partner on the left side of the heart, the mitral valve, earlier this year Boston Scientific made an investment in 4C Medical, leading the startup’s $175 million funding round as it pursues a pivotal study of its globe-shaped AltaValve.