Structural Heart > TAVI Portfolio > ACURATE neo2 > Investigator Initiated Studies



 

1st real-world analysis of device success and clinical safety in next-gen TAVI devices: the supra-annular ACURATE neo2 and intra-annular SAPIEN 3 Ultra valves.

STUDY DESIGN: 1:1 propensity-matched multicenter comparison of device success and clinical safety using the ACURATE neo2 (n = 230) and SAPIEN 3 Ultra (n = 492) valves. 178 total patient pairs were treated and tested at two high-volume centers in Europe.

The ACURATE neo2 Valve demonstrated similar rates of PVL and superior hemodynamics when compared to the SAPIEN 3 Ultra Valve.


1. Kim WK., et al. Multicenter comparison of latest generation of self-expanding versus balloon-expandable transcatheter aortic valves. TCT Congress. 2021.

1st real-world analysis of patient-specific implantation techniques using different devices. The study demonstrated that neo-commissural alignment and optimized valve design can improve procedural success.

STUDY DESIGN: Single-center analysis of commissural alignment results using patient-specific implantation techniques of self-expanding TAVI valves: the ACURATE neo2 (n = 20), Evolut R/PRO™ (n = 20), and Portico™ (n = 20) valves.

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

Results chart
1. Bieliauskas, G, De Backer, O, Sondergaard, L, et al. Patient-Specific Implantation Technique to Obtain Neo-Commissural Alignment with Self-Expanding Transcatheter Aortic Valves. J Am Coll Cardiol 2021.

1st large, real-world clinical data on the ACURATE neo2™ Aortic Valve System*: The Early neo2 Registry

STUDY DESIGN: Core-lab adjudicated, single arm, multicenter registry that assessed the ACURATE neo2 Valve’s performance. 85% of the original patient population (N = 554) were analyzed by an echocardiographic core-lab analysis.

Low overall complication rates and demonstrated PVL improvement: study confirms the enhanced ability of the ACURATE neo2 Valve’s new Active PVseal™ sealing skirt to minimize paravalvular leak.

PVL Icon
Hemodynamic
Coronary Access
2.1%   Stroke Rate      1.3%   Mortality

​* Postoperative echo, core-lab assessed; † In-Hospital; ‡ 30-Days
1. Rück A. Early neo2 Registry. Full Core-Lab Adjudicated Results of TAVI With the New ACURATE neo2 valve. TVT Congress. 2021

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1st systematically-evaluated analysis of coronary access before and after TAVR in an all-comers’ population.

STUDY DESIGN: Comparison of the ACURATE neo (n = 72; 24%), Evolut RTM/PROTM (n = 123; 41%)​ , SAPIEN 3TM/SAPIEN UltraTM (n = 96 patients; 32%), ​and PORTICO (n = 9 patients; 3.2%) valves​. All patients underwent coronary angiography before and after TAVI (N = 300).

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

 

ACURATE neo valve platform

Evolut R/PRO
 

SAPIEN
 

1. Barbanti M, et al.,Reobtain Coronary Ostia Beyond Transcatheter Aortic Valve Stent (RE-ACCESS): J Am Coll Cardiol Intv 2020.
 

 

1st and largest real-world comparison of the ACURATE neo™ self-expanding and SAPIEN 3TM balloon expandable valves.

STUDY DESIGN: 1:2 propensity-matched multicenter comparison of the ACURATE neo (n = 311) and SAPIEN 3 (n = 622) valves 
from three high-volume centers in Germany

60% Risk of PPI icon
-62% Mean Gradient icon
 

 

1st comparison of the ACURATE neoTM self-expanding valve and SAPIEN 3TM balloon expandable valve in patients with small aortic annuli. 

STUDY DESIGN: 1:1 propensity-matched multicenter comparison of the ACURATE neo (n = 92) and SAPIEN 3 (n = 92) valves 
from five high-volume centers in Germany.

-62% Mean Gradient icon
-86% Severe PPM icon
 

 

STUDY DESIGN: Analysis of 249 patients with the ACURATE neoTM (n = 146) and SAPIEN 3TM (n = 103) valves treated with TF TAVI using the minimalist approach at Helsinki University Central Hospital to assess the success rate and safety of NDD at 90 days
and 1 year post-implantation.

 

60% next day discharge success icon
9.2% Device Failure, compared to 6.2% SAPIEN icon
60% Risk of PPI icon
 

 

STUDY DESIGN: Analysis of 296 patients with pre-existing complete RBBB treated with the ACURATE neoTM and SAPIEN 3TM valves (N =296) in a propensity-matched population: ACURATE neo (n = 65) and SAPIEN 3 (n = 65).

 

 

 

 

 


 

Outcomes of two next-generation self-expanding TAVI valves in real-world patients.

STUDY DESIGN: 1:1 propensity-matched multicenter comparison of the ACURATE neo (n = 251) and Evolut PRO (n = 251) valves from 24 international centers

 

9.2% Device Failure, compared to 6.2% SAPIEN icon
safety composite endpoint

 

 

 


 

STUDY DESIGN: Single-center study from Oxford, Great Britain, evaluating the impact of valve selection on procedural outcomes, length of stay (LoS), and 30-day mortality in 231 patients treated with either the ACURATE neo (n = 143) or Evolut R (n = 88) valves.

 

-86% Severe PPM icon
early discharge icon
 

 
 

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