Slide 1: Early neo2 Registry + Quantitative Angiographic Aortic Regurgitation Comparison
Early neo2 Registry + Quantitative Angiographic Aortic Regurgitation Comparison: ACURATE neo to ACURATE neo2 © 2021 Boston Scientific Corporation or its affiliates. All rights reserved. SH- Caution: Investigational Device. Limited by US law to investigational use only. Not available for sale.
Slide 2: Early neo2 Registry data - TVT Late Breaker
Early neo2 Registry data - TVT Late Breaker © 2021 Boston Scientific Corporation or its affiliates. All rights reserved. SH-1014506-AC Caution: Investigational Device. Limited by US law to investigational use only. Not available for sale. 2
Slide 3: Early neo2 Registry – Study summary
Early neo2 Registry – Study summary • Independently core-lab assessed*, Investigator-initiated and conducted, single arm, multicenter and retrospective Design Registry • 12 European centers in Germany, Sweden, Denmark, Austria, Finland, Switzerland and the Netherlands • To document and report the fi
Slide 4: Early neo2 Registry Study Considerations
Early neo2 Registry Study Considerations Early neo2 Registry assessed the performance of ACURATE neo2 +60% Larger Outer Sealing Skirt* Early neo2 Registry SCOPE I & II trial ACURATE IDE *compared to ACURATE neo © 2021 Boston Scientific Corporation or its affiliates. All rights reserved. SH-1014506-A
Slide 5: Early neo2 Registry Sites
Early neo2 Registry Sites Center Site PI n The registry was conducted at 12 European Kerkhoff Klinik, Bad Nauheim Won-Keun Kim 142 centers in Germany (5), Sweden (2), Denmark (1), Austria (1), Finland (1), Karolinska, Stockholm Chris Meduri 86 Switzerland (1) and the Netherlands (1) Herzzentrum Le
Slide 6: Early neo2 Registry – Baseline Characteristics
Early neo2 Registry – Baseline Characteristics 554 consecutive patients implanted with Baseline Characteristics N=554 ACURATE neo2 at 12 centers across Age (yrs) 82 Europe Female % 66 Atrial fibrillation % 38 Prior Pacemaker % 10 EuroSCORE II % 4.5 STS score % 3.7 LVEF % 56 Aortic mean gradient (m
Slide 7: Early neo2 Registry – Procedural Characteristics
Early neo2 Registry – Procedural Characteristics Procedural data N=554 ACURATE neo2 size distribution General anesthesia % 0.2 Femoral access % 99.6 Small (23 mm) Pre-dilatation % 87 21% Post-dilatation % 36 Anulus size mm (average) 23.7 Procedural/In-hospital Complications Large (27 mm) Medium (25
Slide 8: Early neo2 Registry – Primary Outcomes
Early neo2 Registry – Primary Outcomes Primary outcomes Paravalvular Leak Echo Core lab assessed* Paravalvular leak >mild % * 2.7 Post-operative mean gradient (mmHg) * 8.0 New pacemaker implantation (in-hospital) % 6.0 Mortality (30 days) % 1.3 Stroke (in-hospital) % ** 2.1 * By core lab, 85% of 554
Slide 9: Quantitative Angiographic Assessment of Aortic Regurgitation
Quantitative Angiographic Assessment of Aortic Regurgitation Presented at EuroPCR 2021 • Investigator-initiated and conducted retrospective core lab analysis Design • 2 Early neo2 Registry centers (Karolinska University Hospital, Stockholm, Sweden and Kerkhoff Klinik, Bad Nauheim, Germany) • To comp
Slide 10: Cumulative regurgitation
Quantitative Angiographic Assessment of Aortic Regurgitation Presented at EuroPCR 2021 Mean regurgitation fraction Aortic regurgitation severity grade Cumulative frequency P<0.001 100% 1.7% curves of qAR 12 90% P<0.001 13.9% 9.9 80% 10 30.8% Cumulative regurgitation 70% 8 60% 50% 6 40% 50.0% 4.4 4 3
Slide 11: Summary
Summary Early neo2 Registry is the 1st large (n=554) real-world report of clinical experience of ACURATE neo2 including core-lab analysis of echocardiograms. Early neo2 Registry demonstrated a core lab assessed moderate or greater paravalvular leak rate of 2.7%* and new in-hospital pacemaker imp
Slide 12: Study Limitations
Study Limitations The Early neo2 Registry is an investigator-initiated, single-arm, site-conducted retrospective analysis with non-specified enrollment criteria. © 2021 Boston Scientific Corporation or its affiliates. All rights reserved. SH-1014506-AC Caution: Investigational Device. Limited by U
Slide 13: ACURATE neo and neo2 regulatory status notice
In Europe, ACURATE neo and ACURATE neo2 Aortic Valve Systems are CE-marked. In the USA, ACURATE neo2 is an investigational device and restricted under federal law to investigational use only. Not available for sale. Products shown for informational purposes only – not meant as promotion or offer for