Discontinuation of the ACURATE transcatheter heart valve platform: loss or reckoning?

The self-expanding ACURATE transcatheter heart valve (Boston Scientific) received European Conformity (CE) mark approval in 2011 and has since progressed to its third-generation iteration, from “neo” to “neo2” to “Prime” (Figure 1). Despite its successful use for over a decade, on 28 May 2025, Boston Scientific announced the discontinuation of the ACURATE platform. This decision is considered a consequential response to disappointing results in the randomised IDE trial with ACURATE neo2 (ClinicalTrials.gov: NCT03735667), which was preceded several years ago by negative outcomes in the SCOPE I (NCT03011346) and SCOPE II (NCT03192813) trials with the first-generation ACURATE neo valve (Figure 1). Hence, critical voices may perceive this withdrawal as scientific reckoning, but this warrants a nuanced interpretation. The SCOPE trials lacked computed tomography core laboratory adjudication and centralised screening and included sites with limited experience using this platform. The outcomes in the IDE trial were largely driven by underexpansion – a procedural issue that was found to be preventable and correctable when adhering to the manufacturer’s procedural recommendations, rather than being a device-inherent flaw1. Even though...