Boston Scientific has announced the surprise move to cease sales of its Acurate transcatheter aortic valve implantation (TAVI) systems, including the Acurate neo2 and Acurate Prime devices.
In a statement, the company said that the decision was taken following discussions with regulators and that it would cease all commercial and clinical activities related to the devices.
“Boston Scientific is discontinuing worldwide sales of the Acurate neo2 and Acurate Prime aortic valve systems,” the statement reads. “While data continue to support the performance of the Acurate valve system when the product’s optimised instructions for use are followed, this decision was made based on recent discussions with regulators which resulted in increased clinical and regulatory requirements to maintain approvals in global markets and to obtain approval in new markets.
“Therefore, related commercial, clinical, research and development, and manufacturing activities will cease.”
As was previously reported, Boston Scientific had been seeking US Food and Drug Administration (FDA) approval for the Acurate neo2 platform—which has been available and widely in use in Europe since 2020. The self-expanding, supra-annular Acurate neo2 system features an annular sealing technology designed to conform to irregular, calcified anatomies and minimise paravalvular leaking (PVL). The newer Acurate Prime platform was granted CE mark in August 2024.
The company had encountered an unanticipated setback in its bid for FDA approval for neo2 with results of the ACURATE IDE trial, reported at the 2024 TCT meeting (27–30 October, Washington, DC, USA), showing that the device had failed to meet the prespecified 8% non-inferiority margin across a combined endpoint of all-cause mortality, stroke or rehospitalisation at one year versus the Evolut (Medtronic) and Sapien 3 (Edwards Lifesciences) devices.
Observational data from implanters in Europe had appeared to validate the clinical performance of the neo2 valve, with an analysis presented at the 2025 Cardiovascular Research Technologies (CRT) meeting (8–11 March, Washington DC, USA), which emulated the conditions of the IDE trial, showing non-inferiority of Acurate neo2 against the competitor valves.
Despite the initial setback, investigators had been keen to establish an explanation for the valve’s underperformance in the IDE trial and valve under-expansion—which may have occurred in some instances due to operator inexperience in handling the platform—had been identified as being a key contributor to the negative result.
A post-hoc review of cases from the IDE trial was presented last week at EuroPCR 2025 (20–23 May, Paris, France), and published simultaneously in the Journal of the American College of Cardiology (JACC), and appeared to support this theory, showing that as many as 21.6% of patients in the trial had under-expanded valves which was associated with a higher one-year rate of death, stroke or rehospitalisation.
Presenting the findings, Raj Makkar (Cedars-Sinai, Los Angeles, USA) detailed that valve under-expansion was more common in patients with high leaflet or annular calcification burden, “which is consistent with the valve’s lower radial opening force, and this was associated with higher rates of the primary endpoint”.
“I think it is fair to say that valve design modification to increase radial strength and careful consideration of pre- and post-dilatation may improve valve expansion,” added Makkar. “Whether improvement and optimisation of Acurate neo2 valve expansion translates into better clinical outcomes is something that needs to be further investigated.”
Attendees of EuroPCR also heard the first real-world results of the use of the newer Acurate Prime device, with findings of the Early ACURATE Prime registry presented during a hotline session at the meeting by Andreas Rück (Karolinska University Hospital Stockholm, Stockholm, Sweden).
Rück detailed that the Prime platform included updates from the previous generation which includes the availability of larger sizing and increased radial strength, alongside changes to the delivery system intended to aid deployment and commissural alignment
The results from the registry, which included data from 517 all-comers patients, demonstrated high rates of technical success and 30-day device success, as well as favourable echocardiographic results and a single-digit pacemaker rate.
“At Karolinska we have been among the largest users worldwide of the Acurate,” Rück commented to Cardiovascular News, in response to the news of the withdrawal of both devices from the market. “Clearly Acurate Prime can give excellent results, as we recently showed in the Early ACURATE Prime registry presented at EuroPCR. Also the previous Acurate neo2 generation has equivalent results as competitor valves in Swedish registry data with one year follow-up shown at CRT, and in other European datasets.
“What this shows is that it not just the product design that matters, it is also how it is used and how the company communicates best practice, especially when trying to enter the US market. It just needs a little finesse. That is where the mistakes were made.”
