Structural Heart > TAVI Portfolio > ACURATE neo2 > Boston Scientific Clinical Studies


The ACURATE platform has demonstrated consistently strong clinical performance and the potential to help improve TAVI program efficiency across multiple clinical trials and registries.

 
 

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

Low device usage time, 3.9 minutes icon

3.9min

Average Device
Usage Time†,2

High procedural success rates, 97.5 percent icon

97.5%

Procedural
Success2

PVL at 7 Days/Discharge, 30 Days, and 1 year1

CE mark trial
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* 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

 

PVL, Paired Analysis

progress pvl trial chard
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1. PRospective Observation of aortic reGuRgitation aftEr TAVI and progreSS over time (PROGRESS) PVL registry., Presented by W.K. Kim at PCR e-Course June 25-27, 2020

 
 

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

High procedural success rates, 97.5 percent icon

98.7%

Procedural Success 
 

Low device usage time, 3.9 minutes icon

6.34Min

Average Device
Usage Time*

Zero coronary obstruction, 0.0% icon

0.0%

Coronary
Obstruction†

Low PPI 8.3%, icon

8.3%

New Permanent
Pacemaker Rate

complication rate icon

1.4%

All-Cause
Mortality

Low mean gradient, 4.4 mmHg icon

8.4mmHg

Mean
Gradient‡

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*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.

 
 
 

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