After postponing its U.S. plans at the top of this year, Boston Scientific has now secured an earlier-than-previously-expected European approval for its latest transcatheter aortic valve replacement implant.
The company’s Acurate Prime system is largely built on the same platform as its predecessor—the Acurate neo2, which first launched on the continent in late 2020—but includes an additional valve size to accommodate patients with larger or more challenging anatomy.
The self-expanding TAVR implant’s CE mark covers its use in patients with a severe narrowing of their aortic valve, including those at either low, intermediate or high risk for open heart surgery.
The Prime’s sizes allow for the treatment of people with aortic annulus diameters between 20.5 and 29 millimeters. Like the neo2 before it, it also features an open upper frame that lets clinicians more easily access the coronary arteries during any future catheter-based procedures.
Earlier this year, Boston Scientific reported that the continued commercial growth of Acurate neo2 in Europe helped push its structural heart revenue to double-digit gains year over year. At the same time, the company had previously slated the Acurate Prime’s European approval and launch for the 2025 calendar year.
Now, Boston Scientific said it plans to begin rolling out the implant within the coming weeks.
In January, during the company’s fourth-quarter 2023 earnings call, CEO Michael Mahoney said a planned interim trial analysis had pushed back plans to submit Acurate Prime for a U.S. approval in 2024.
Instead, it would suspend enrollment in a single-arm study and plan to wait for full, one-year data from a randomized trial of 1,500 patients before moving forward at the FDA.
In July’s second-quarter earnings report, Mahoney said the study had completed its enrollment—describing it as “the largest randomized trial that's been done in TAVI”—and that the company expects to present its findings “in the first half of 2025, likely at the annual ACC meeting” scheduled for next March in Chicago.
According to Boston Scientific, nearly 80,000 patients worldwide have been treated with its Acurate valve platforms, though both the neo2 and Prime have yet to be approved in the U.S.