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 compendium

ACURATE neo2™ Aortic Valve System

5-Year outcomes with ACURATE neo2 valve: the ACURATE neo AS CE-mark study

Presented at EuroPCR 2023 congress in Paris, the first report of longer-term (5 years) outcomes with ACURATE neo2 confirms favorable performance and sustained safety in a high risk population of patients with severe aortic stenosis.


POLESTAR Trial – An International Multi-centre Early Discharge TAVI Program

Presented at EuroPCR 2023 congress in Paris, the results of the study demonstrated no statistically significant differences in safety and efficacy endpoints between early discharged and non-early discharged groups. Additionally, rates of moderate aortic regurgitation were low in all patients.


ACURATE neo2 PMCF Study

Presented at PCR London Valves 2022 the results of the 250 patient independent core lab assessed ACURATE neo2 PMCF study demonstrating strong performance with excellent clinical outcomes at discharge and 30 days.


SCOPE I – 3 year data

Released at TCT 2022, the largest report of patient outcomes with the ACURATE platform beyond one year after TAVR demonstrating excellent hemodynamics and promising ACURATE neo durability outcomes to 3 years.


SAPIEN 3 Ultra vs. ACURATE neo2

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


NEOPRO 2 Sub-Study

ACURATE neo2 Valve outcomes presented at TVT 2022


ACURATE neo2 CE-Mark Study (ACURATE neo AS)

High procedural efficiency and low core-lab adjudicated PVL rates that improve over time.


SCOPE II Sub-Study

Assessment of PPI predictors from the SCOPE II clinical trial.


MORENA

The ACURATE neo Valve demonstrated lower permanent pacemaker implantation rates (PPI) and superior hemodynamic performance compared to the SAPIEN 3 Valve.


Mauri, et al. Small Annulus

The ACURATE neo Valve demonstrated superior hemodynamic performance and lower risk of prosthesis-patient mismatch (PPM) in patients with small aortic annuli.


Next-Day Discharge (NDD)

The ACURATE neo Valve demonstrated higher rates of early patient discharge and lower rates of new permanent pacemaker (PPI).


The ACURATE neo Post-Market Registry (SAVI TF)

Strong safety and efficacy data at 30 days.


SELECT RBBB

The ACURATE neo Valve demonstrated lower permanent pacemaker implantation rates (PPI) in patients with pre-existing right bundle branch block (RBBB).


Post-Operative Length of Stay (LoS) Registry: ACURATE neo vs. Evolut R

The ACURATE neo Valve demonstrated reduced pacemaker rates and shorter hospital lengths of stay (LoS).


PROGRESS PVL

Low core-lab adjudicated PVL rates that improve between discharge and 12 months.


NEOPRO Registry: ACURATE neo vs. Evolut PRO

The ACURATE neo Valve demonstrated comparable clinical outcomes at 30 Days.


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