Boston Scientific announced Wednesday it will discontinue global sales of its Acurate family of transcatheter aortic valve replacement (TAVR) systems and abandon pursuit of FDA approval in the United States, marking another significant setback in the company's efforts to compete in the lucrative heart valve market.
The decision follows discussions with regulators that resulted in "increased clinical and regulatory requirements to maintain approvals in global markets and to obtain approval in new markets," according to a company spokesperson. CEO Mike Mahoney called the discontinuation "disappointing" at Bernstein's Annual Strategic Decisions Conference, stating there "wasn't a clear path that made sense in the U.S."
Clinical Trial Results Drive Decision
The withdrawal comes after Boston Scientific's Acurate neo2 device failed to meet non-inferiority criteria in a pivotal clinical trial. The study, published in The Lancet and involving 1,500 patients with symptomatic severe aortic stenosis, showed that participants who underwent the Acurate neo2 procedure experienced "significantly higher" rates of mortality, stroke, and rehospitalization compared to control groups implanted with Edwards Lifesciences' Sapien 3 and Medtronic's Evolut devices.
According to study leaders, approximately one-in-five of the Acurate valves were not fully expanded during procedures, leading to more turbulent blood flow through the implant and potentially driving the formation of heart attack- or stroke-causing clots in subsequent months. While 30-day safety data appeared on track, the incorrect placement pulled down the one-year results.
Financial and Employment Impact
The Acurate business generated approximately $200 million in sales last year, according to Needham analyst Mike Matson. Despite the financial impact of discontinuing the program, Boston Scientific expects to achieve its second-quarter and full-year sales goals, though the company is not reaffirming its earnings-per-share projections.
The discontinuation will lead to job reductions, though the company has not disclosed the number of roles to be eliminated or their locations. Boston Scientific stated it is focused on redeploying team members "to priority programs and manufacturing areas across the company" to reduce the impact.
Second TAVR Setback
This marks Boston Scientific's second major failure in the TAVR market. The company previously cut 106 jobs after announcing in November 2020 it was winding down its Lotus Edge program due to device delivery issues. The Lotus system faced recalls and sales pauses, with engineers, analysts, sales representatives, managers, and others at the company's Maple Grove plant losing their positions.
Boston Scientific originally acquired the Acurate TAVR systems through its $435 million cash acquisition of Swiss valve developer Symetis in 2017. Over the past five years, Acurate valves have been available in more than 50 countries and used to treat more than 80,000 patients.
Market Context
The transcatheter aortic valve replacement market is described by Mahoney as "mature and very large." Unlike traditional heart valves requiring open-chest surgery, transcatheter valves are implanted using thin tubes called catheters that run from a small puncture in the blood vessel to the heart. The market is currently dominated by companies such as Medtronic and Edwards Lifesciences.
J.P. Morgan analyst Robbie Marcus views the decision as the right strategy for Boston Scientific despite short-term impacts, noting the product's "mixed clinical track record and complicated path to US approval." The analyst stated they were "not surprised by Boston's choice to discontinue the product and redirect its time, effort, and dollars elsewhere."
