Illustration of the ACURATE neo2 Aortic Valve System in anatomy. Supra-annular TAVI.

Clinical data

Early neo2 Registry core-lab results

First large, real-world clinical data on the ACURATE neo2™ Aortic Valve System*: The Early neo2 Registry

Independently studying 85% of the original study’s 554 patients, the Early neo2 Registry core-lab analysis confirmed minimized paravalvular leak rates with the ACURATE neo2 Valve and its Active PVsealTM  sealing skirt.

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6.0%

new permanent pacemaker

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2.7%

moderate to severe PVL1

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8.0mmHg

mean gradient

1. Möllmann H, Holzhey DM, Hilker M, et al. The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes. Clin Res Cardiol. 2021;110(12):1912–1920.

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COMALIGN Study

First real-world analysis of patient-specific implantation techniques using different devices. The COMALIGN study demonstrated that neo-commissural alignment and optimized valve design can improve procedural success.

Best-in-class commissural alignment: ACURATE neo2 was the only self-expanding valve to 100% avoid commissural misalignment.2

2. Bieliauskas G, Wong I, Bajoras V, et al. Patient-specific implantation technique to obtain neo-commissural alignment with self-expanding transcatheter aortic valves. J Am Coll Cardiol 2021;14(19):2097-2108.
0% moderate or severe commissural misalignment
 ACURATE neo2 Valve

0% moderate or severe commissural misalignment
ACURATE neo2 Valve

20/20 successful consecutive cases

10% moderate or severe commissural misalignment 
Evolut R™/PRO Valve

10% moderate or severe commissural misalignment
Evolut™ R/PRO Valve

17/20 successful consecutive cases; 3 cases with non-optimal rotations

25% moderate or severe commissural misalignment 
PORTICO™ Valve

25% moderate or severe commissural misalignment
PORTICO™ Valve

15/20 successful consecutive cases; 5 cases difficult to assess

RE-ACCESS Study

First systematically evaluated analysis of coronary access before and after TAVI in an all-comers’ population

With 0 incidences of unsuccessful coronary cannulation, ACURATE neo demonstrated an extremely high coronary access success rate.

100%

ACURATE neo™ Valve Platform

100% successful coronary cannulation
n = 723

82%

Evolut™ R/PRO

82% successful coronary cannulation
n = 1233

99%

SAPIEN Platform

99% successful coronary cannulation
n = 963

3. Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS); NCT04026204 J Am Coll Cardiol Intv. 2020.

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1. Möllmann H, Holzhey DM, Hilker M, et al. The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes. Clin Res Cardiol. 2021;110(12):1912–1920.

2. Bieliauskas G, Wong I, Bajoras V, et al. Patient-specific implantation technique to obtain neo-commissural alignment with self-expanding transcatheter aortic valves. J Am Coll Cardiol 2021;14(19):2097-2108.

3. Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS); NCT04026204. J Am Coll Cardiol Intv. 2020.

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