The registry evaluates the Acurate Prime aortic valve system, the Marlborough, Massachusetts-based company’s next-generation technology. It enhances the Acurate neo2 transcatheter aortic valve replacement (TAVR) system, including a full-sized matrix. The system treats patients with severe symptomatic aortic stenosis across all surgical risk levels.
Boston Scientific’s study investigates the safety and effectiveness of the larger Acurate Prime aortic valve XL (29mm). It includes 50 nonrandomized patients across 20 centers in the U.S., according to a LinkedIn post. All subjects previously enrolled in the main randomized controlled trial cohort of the ACURATE IDE trial.
In the non-randomized registry, a cohort of subjects receive Acurate Prime. Boston Scientific plans to summarize data from the nested registry separately from the randomized and roll-in cohorts. The randomized cohort includes a 1:1 randomization comparing Acurate against commercially available TAVR systems — Edwards’ Sapien 3 or CoreValve, CoreValve Evolut or the Evolut Pro system from Medtronic. That randomized trial includes 1,500 subjects, according to ClinicalTrials.gov.
For the nested registry, all subjects implanted receive follow-up at baseline, peri- and post-procedure at discharge or seven days post-procedure, 30 days, six months then annually for up to 10 years post-procedure. Enrolled subjects without a device implanted undergo one-year post-procedure assessments for safety/adverse events.
Read next: Boston Scientific targets M&A, AI to reach ‘next level’
