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


Across multiple clinical studies and investigator initiated or sponsored trials, the ACURATE platform demonstrates consistently excellent clinical performance and the potential to improve TAVI program efficiency.

 
 

ACURATE neo2 CE-Mark Study* 1 2

See the data from the 1st clinical review of ACURATE neo2 Aortic Valve System with the new Active PVseal™ sealing technology.

High Procedural Efficiency and Very Low Core Lab Adjudicated PVL Rates That Improve Over Time

(N = 120)

Low device usage time, 3.9 minutes icon

3.9min

Average Device
Usage Time†

High procedural success rates, 97.5 percent icon

97.5%

High Procedural
Success ‡

pvl icon

3.0%

≥ Moderate PVL at 30 Days‡

pvl icon

2.5%

≥ Moderate PVL at 1 Year§

  View the Full Results  

* 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
§ Limited clinical data has shown a numerical decrease in frequency and severity of PVL in ACURATE neo2 as compared to ACURATE neo.
‡ In 2 patients, valve-in-valve implantation of a non-study valve was required (valve embolization, n=1; valve dislodgement/migration, n=1); In 1 patient, post-dilatation resulted in ventricular septal perforation and conversion to open-heart surgery
1. 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.
2. Transcatheter Aortic Valve Replacement With the ACURATE neo2 Valve System: 1 Year Clinical and Hemodynamic Outcomes. Presented by H. Möllmann at TVT Chicago 2019.

 
 

PROGRESS PVL1

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.

Low Core-Lab Adjudicated PVL Rates

(N = 209)

pvl icon

4.3%

≥ Moderate PVL
at Discharge

pvl icon

2.9%

≥ Moderate PVL
at 1-Year

  View the Full Results  

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 Registry1,2

Largest series, all-comers experience of ACURATE neo™ Aortic Valve System .

Strong Safety and Efficacy Data at 30 Days1

(N = 1,000)

High procedural success rates, 97.5 percent icon

98.7%

High Procedural Success 
 

Low device usage time, 3.9 minutes icon

6.34Min

Low Device
Usage Time*

Zero coronary obstruction, 0.0% icon

0.0%

Zero Coronary
Obstruction†

 

Low PPI 8.3%, icon

8.3%

Low
PPI

 

complication rate icon

1.4%

All-Cause
Mortality

Low mean gradient, 4.4 mmHg icon

8.4mmHg

Low Mean
Gradient‡

  View the Full Results  

*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.
2. Kim W, MD, et al. 1-year outcomes of the European post-market registry using the ACURATE neo transcatheter heart valve under real-world conditions in 1,000 patients. JACC: Cardiovasc Interv. 2018;11(14):1368-1374.

 
 
 

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