ACURATE neo™

Aortic Valve System

Design

Clinical Evidence

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Clinical Evidence

Boston Scientific Clinical Trials

Investigator Initiated Trials

Boston Scientific Clinical Trials

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SAVI-TF Post-Market Registry

Real-world experience using the ACURATE neo prosthesis: 30-day outcomes of 1,000 patients enrolled
in the SAVI-TF registry
- Möllmann H et al.; EuroIntervention 2018;13:e1764-e1770

One-year outcomes of the european post-market registry using the ACURATE neo transcatheter heart valve under real world conditions in 1,000 patients
- Kim et al.; JACC: Cardiovascular Interventions vol. 11, no.1 4, 2 0 1 8; July 23, 2018: 1368–74
Study design
 
European, single-arm, multicenter, all-comers registry, 1,000 patients from
25 centers in Europe directly following CE-marking of ACURATE neo between
October 2014 and April 2016.
Download ACURATE neo SAVI-TF Clinical Data Sheet
Results
 

Confirmed safety and performance:

  • Strong safety and effectiveness data
  • Very low complication and pacemaker rates
  • Low mortality and excellent hemodynamic performance

Outcomes¹

Procedural efficiency
 

SAVI-TF RESULTS SUMMARY

(% of patients)

SAVI-TF Results Summary
 

HEMODYNAMIC PERFORMANCE

(mmHg/cm2)

SAVI-TF Results Summary
Prof. Dr. Helge Möllmann video TCT 2017

Clinical data presentation – TCT 2017

"ACURATE neo TF Valve: Review of the Device and the SAVI-TF1000 Data"

Prof. Dr. Helge Möllmann
Dortmund, Germany


 

ACURATE neo TA CE-Mark Study

Prospective multicenter evaluation of a novel, low-profile transapical delivery system for self-expandable transcatheter aortic valve implantation: 6-month outcomes
Conradi L., Hilker M., Kempfert J., Börgermann J., Treede H., Holzhey DM. et al. Eur J Cardiothorac Surg 2018; doi:10.1093/ejcts/ezy097.
Study design
 
The prospective, multi-center evaluation assessed the safety and performance of the ACURATE neo Transapical Aortic Valve System in 60 high-risk patients ineligible for transfemoral access due to high rates of comorbidities at seven German centers.
Download ACURATE neo TA CE-mark Study clinical summary
Results
 

ACURATE neo demonstrated:

  • Safety and efficacy in patients with severe symptomatic aortic stenosis and high surgical risk, ineligible for transfemoral access
  • High device and procedural success, short implantation times and a low rate of access site related complications
 

High device & procedural success

98.3%

Procedural/device success

3:00

Average device usage time

5.9 mmHg

Mean transvalvular gradients at 30 days

 

ACURATE neo TA SAFETY & PERFORMANCE

(% of patients unless otherwise stated)

Safety and Performance
 

ECHOCARDIOGRAPHIC FOLLOW-UP

Echocardiographic follow-up

NYHA CLASSIFICATION

 
NYHA classification
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