Aortic Valve System
Boston Scientific Clinical Trials
- Kim, WK, Presented PCR e-Course June 25-27, 2020
The PROGRESS PVL Registry:
- Confirms the high procedural success rate, low overall VARC-2 complication rates, and excellent hemodynamic performance of the ACURATE neo Valve Platform seen across multiple studies and registries.
- Shows low core-lab adjudicated paravalvular leakage (PVL) rates (4.3% ≥moderate at discharge, 2.9% (at 1-year) and a significant overall improvement between discharge and 1 year in a paired analysis (P<0.001).
PVL, Paired Analysis
(N = 209, core-lab adjudicated)
(mmHg/cm2, core-lab adjudicated)
in the SAVI-TF registry
- Möllmann H et al.; EuroIntervention 2018;13:e1764-e1770
One-year outcomes of the european post-market registry using the ACURATE neo transcatheter heart valve under real world conditions in 1,000 patients
- Kim et al.; JACC: Cardiovascular Interventions vol. 11, no.1 4, 2 0 1 8; July 23, 2018: 1368–74
25 centers in Europe directly following CE-marking of ACURATE neo between
October 2014 and April 2016.
Confirmed safety and performance:
- Strong safety and effectiveness data
- Very low complication and pacemaker rates
- Low mortality and excellent hemodynamic performance
SAVI-TF RESULTS SUMMARY
(% of patients)
Clinical data presentation – TCT 2017
"ACURATE neo TF Valve: Review of the Device and the SAVI-TF1000 Data"
Prof. Dr. Helge Möllmann