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

CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France. Product available in the European Economic Area (EEA) only. Please check availability with your local sales representative or customer service