ACURATE neo™ Aortic Valve System shows safety & efficacy results comparable to SAPIEN 3

Sponsored by Boston Scientific

Multi-centre propensity-matched comparison study1 between ACURATE neo Aortic Valve System and Edwards SAPIEN 3 Transcatheter Heart Valve, published in October’s edition of the Journal of the American College of Cardiology (JACC) shows comparable procedural outcomes.

List of outcomes:

  • Observational, propensity-matched multicenter comparison of ACURATE neo and SAPIEN 3 from 3 high volume centers in Germany (DHZ Munich, UK Regensburg, Kerckhoff Klinikum Bad Nauheim)
  • 1,121 consecutive patients between Jan. 2014 and Jan. 2016 with symptomatic, severe stenosis of the native aortic valve treated with transfemoral TAVI using ACURATE neo (n = 311) or SAPIEN 3 (n = 810)
  • To increase statistical power, a 1-to-2 nearest neighbor matching was used to identify 2 control cases treated with SAPIEN 3 (n = 622) for each case treated with ACURATE neo (n = 311)
  • Endpoints: device failure and early safety composite endpoint at 30 days according to VARC-2 criteria

View full JACC publication

Key facts highlighted in the study:

Comparable performance for ACURATE neo and SAPIEN 3 with no significant differences at 30 days in safety outcomes, including the VARC-2 early safety and device failure composite endpoints.*

Morena - Publication summary: ACURATE neo vs. SAPIEN 3

Download publication summary

Key facts highlighted in the study


See interview with Won-Keun Kim, Germany - Learnings from MORENA comparitive analysis - PCR London Valves 2017

© Europa Group – Original recording at PCR London Valves 2017


* Comparable VARC-2 device failure composite endpoint with ACURATE neo versus SAPIEN 3 (10.9% vs. 9.6%, p=n.s.) and early safety composite endpoint (15.8% vs. 15.6%, p=n.s.).
** According to VARC-2, elevated gradients >20 mmHg are defined as mild stenosis, are assessed as Device Failure and may indicate prosthetic valve dysfunction.

  1. Husser O, et al. Multicenter comparison of novel self-expanding versus balloon-expandable transcatheter heart valves. JACC Cardiovasc Interv. 2017 Oct 23;10(20):2078-2087.

SH-512201-AA NOV2017

Page published on December 2017


With an unrestricted educational grant from Boston Scientific


This case report does not reflect the opinion of PCR or PCRonline, nor does it engage their responsibility.