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Medical Specialties > Structural Heart > TVT 2021 Clinical Presentation

Early neo2 Registry Core-Lab Analysis1

 

12 SITES  |  N = 554 PATIENTS

 

The Early neo2 Registry is an investigator-initiated and conducted, single arm, multicenter registry that assessed the ACURATE neo2 Aortic Valve System’s performance.1

Early neo2 Registry
  Watch Replay  
 
Echocardiographic images of 85% of the Early neo2 Registry patients were analyzed by an echocardiographic core-lab analysis and presented by Dr. Andreas Rück from the Karolinska Institute (Stockholm, Sweden) at TVT, 2021. View the presentation.2
 

 

Clinical Outcomes

 

The ACURATE neo2 Valve performed consistently for key patient outcomes:

 
Hemodynamic

2.7%

moderate/severe PVL*

Hemodynamic

8mmHg

mean gradient*

Coronary Access

6.0%

new permanent
pacemaker†

stroke icon

2.1%

stroke rate†

Complication Rates

1.3%

mortality‡

Complication Rates

0.0%

coronary obstruction§

* Post-procedure echo. Core-Lab assessed site-reported; † In-Hospital; ‡ 30-Days; § Procedural
 
 

 

Paravalvular Leak Comparison

 

The independent Early neo2 Registry’s core-lab analysis studied 85% of the original study’s 554 patients.

Post-Procedure PVL

 

Percent of evaluable echocardiograms demonstrating post-procedure PVL rates from the core-lab adjudicated Early neo2 Registry.2

Active PVseal
 
Watch a Replay of the Early neo2 Registry Core-Lab Results Presentation
 
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