ACURATE neo™

Aortic Valve System

ACURATE neo Key Clinical Outcomes

From early studies establishing safety and efficacy to head-to-head studies that show how ACURATE neo performs against other valves, it continues to undergo rigorous testing and demonstrate outstanding clinical outcomes.

Strong safety and efficacy data at 30 days and 1 year in a 1,000-patient real-world, all comers registry1,2

Short implantation
times and very low reported pacemaker rates 1,2,3,4
High, procedural success and very low complication rates and mortality in line with contemporary registries with other available TAVI syystems and comparable to SAPIEN 3 in two propensity-matched studies 1,2,3,4
Superior hemodynamic performance observed in patients with small annuli with larger EOAs, lower transvalvular gradients and lower rates of prosthesis-patient mismatch as compared to SAPIEN 3,4


Published Clinical Trials

Boston Scientific Clinical Trials

SAVI-TF
Post-Market Registry
 
ACURATE neo
Real-world
ACURATE neo experience
ACURATE neo TA 
CE-Mark Study
 
ACURATE neo
Evaluation of ACURATE neo with novel, low-profile transapical delivery system

Investigator Sponsored (ISR) and Initiated (IIT) Trials

NEOPRO Registry
Multicenter Comparison Study
ACURATE neo vs. Evolut PRO
30 Days in hospital before discharge
Outcome in patients with pre-existent Right Bundle Branch Block and impact on pacemaker implantations 
SELECT RBBB Registry
The SELECT RBBB Multicenter Registry

ACURATE neo Key Clinical Outcomes
Outcome of a next-generation self-expandable and balloon-expandable TAVI valve in real-world patients

Investigator Sponsored (ISR) and Initiated (IIT) Trials

Kotronias et al. (IIT)
Single-Centre comparison between
ACURATE neo and Evolut R
30 Days in hospital before discharge
Outcome in patients with pre-existent Right Bundle Branch Block and impact on pacemaker implantations 
Laine et al (IIT) 
Single-Centre comparison between
ACURATE neo and SAPIEN 3
ACURATE neo Key Clinical Outcomes
Outcome of a next-generation self-expandable and balloon-expandable TAVI valve in real-world patients
MORENA
Multicenter Comparison Study
ACURATE neo vs. SAPIEN 3
ACURATE neo Key Clinical Outcomes
Outcomes of next-generation self-expanding vs. balloon-expandable TAVI valves in real world patients.
 
Mauri, et al.
Multicenter Comparison Study in
Small Annuli ACURATE neo vs. SAPIEN 3
ACURATE neo
Outcomes of next-generation self-expanding vs. balloon-expandable TAVI valves in real-world patients with small aortic annuli.

Wrap-up interview - PCR London Valves 2018

"ACURATE neo is a supra-annular working valve, so you can expect low-residual transvalvular gradients."

Nicolas van Mieghem, MD, PhD.
Rotterdam, Netherlands


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