ACURATE neo™

Aortic Valve System

Boston Scientific Clinical Trials

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PROGRESS PVL Registry

The PRospective Observation of aortic reGuRgitation aftEr TAVI and progreSS over time (PROGRESS) PVL registry
- Kim, WK, Presented PCR e-Course June 25-27, 2020
 
An open-label, single arm study of 500 patients enrolled at 22 centers in Germany, Canada, the United Kingdom, and Italy between January 2017 and July 2018.
 

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)

x
 

Hemodynamic Performance

(mmHg/cm2, core-lab adjudicated)

x
 

SAVI-TF Post-Market Registry

Real-world experience using the ACURATE neo prosthesis: 30-day outcomes of 1,000 patients enrolled
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
 
European, single-arm, multicenter, all-comers registry, 1,000 patients from
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

Outcomes¹


Procedural efficiency

 

SAVI-TF RESULTS SUMMARY

(% of patients)

SAVI-TF Results Summary
 

HEMODYNAMIC PERFORMANCE

(mmHg/cm2)

SAVI-TF Results Summary

Clinical data presentation – TCT 2017

"ACURATE neo TF Valve: Review of the Device and the SAVI-TF1000 Data"

Prof. Dr. Helge Möllmann
Dortmund, Germany

 
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