ACURATE neo2 CE-Mark Study*,1,2
The 1st clinical review of the ACURATE neo2 Aortic Valve System with new Active PVseal™ sealing technology.
STUDY DESIGN: N=120; European, prospective, single arm, multicenter study
High Procedural Efficiency and Low Core-Lab Adjudicated PVL Rates That Improve Over Time
PVL at 7 Days/Discharge, 30 Days, and 1 year1
* Device in study named ACURATE neo AS. Core-laboratory adjudicated data among patients in whom echocardiography was performed and with follow-up data available for the given time points.
† Average device usage time ± 3.5 min
1. Transcatheter Aortic Valve Replacement With the ACURATE neo2 Valve System: 1 Year Clinical and Hemodynamic Outcomes. Presented by H. Möllmann at TVT Chicago 2019.
2. Transcatheter aortic valve implantation for severe aortic valve stenosis with the ACURATE neo2 valve system: 30-day safety and performance outcomes. Presented by H. Möllmann at PCR London Valves 2018..
PROGRESS PVL1
PRospective Observation of aortic reGuRgitation aftEr TAVI and progreSS over time (PROGRESS) PVL registry.
STUDY DESIGN: N=500; open-label, single arm, multicenter registry at 22 centers in
Germany, Canada, the United Kingdom, and Italy
Low Core-Lab Adjudicated PVL Rates that Improve Between Discharge and 12 Months
SAVI-TF Post-Marked Registry1
Largest series, all-comers experience of ACURATE neo™ Aortic Valve System
STUDY DESIGN: N = 1,000; Real-world, European, prospective, single-arm, multicenter, all-comers registry
Strong Safety and Efficacy Data at 30 Days1
*Average usage time: 6:34±6:18
†Requiring re-intervention.
‡Mean gradient ± 4.0 mmHg at discharge or 7 days.
1. Möllmann H, et al. Real-world experience using the ACURATE neo prosthesis: 30-day outcomes of 1,000 patients enrolled in the SAVI-TF registry. EuroIntervention. 2018;13:e1764-e1770.