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Presentation TCT 2025

TCT 732: Peri-device Leak and Clinical Outcomes After LAAC Using a Fluoropolymer Coated Device in Patients with Paroxysmal vs. Persistent Atrial Fibrillation: HEAL-LAA Post Approval Study Sub-analysis

Presenter: Thomas E. Waggoner

October 28, 2025

Presentation TCT 2025

Electrosurgical Tools in Structural Heart Interventions: How to Drive Best Practices, Device Development, and Regulatory Approval

Presenter: Adam B. Greenbaum

October 28, 2025

Presentation TCT 2025

TCT 704: Outcomes After LAAC Using a Fluoropolymer Coated Device in Patients of Historically Underrepresented Racial and Ethnic Groups: A Sub-analysis of the HEAL-LAA Post Approval Study

Presenter: Seun Alli

October 27, 2025

Presentation TCT 2025

Comparative Outcomes of ICE vs. TEE Guided LACC with Amulet Device: Insights from EMERGE LAA Post-Approval Study

Presenter: Mohamad A. Alkhouli

October 26, 2025

Presentation NY Valves 2025

Outcomes of TEE vs. ICE-guided Left Atrial Appendage Closure Using a Fluoropolymer Coated Device: A Sub-analysis of the HEAL-LAA Post Approval Study

Presenter: Seun Alli

June 26, 2025

Presentation NY Valves 2025

Outcomes in Patients Discharged on OAC vs. DAPT After Left Atrial Appendage Occlusion Using a Fluoropolymer Coated Device: A Sub-analysis of the HEAL-LAA Post Approval Study

Presenter: Seun Alli

June 25, 2025

Presentation NY Valves 2025

Outcomes of Same-day vs. Delayed Discharge After LAAC Using a Fluoropolymer Coated Device: HEAL-LAA Post Approval Study Sub-analysis

Presenter: Jeremiah P. Depta

June 25, 2025

Presentation TCT 2024

Left Atrial Appendage Closure with a Novel Fluoropolymer-Coated Device: The HEAL-LAA Post-Approval Clinical Study

Presenter: Seun Alli

October 30, 2024

Presentation NY Valves 2024

Patient and Device Selection Following Commercial Approval of TTVI Devices: European Perspectives

Presenter: Jörg Hausleiter

June 05, 2024

Presentation TCT 2023

PROs Alone in Non-Blinded Studies Shouldn’t Drive Device Approval

Presenter: Nir Uriel

October 25, 2023

Presentation TCT 2023

Clinician Perspectives

Presenter: Roxana Mehran

October 24, 2023

Presentation TCT 2023

Industry Perspectives

Presenter: Duane Pinto

October 24, 2023

Presentation TCT 2023

FDA Perspectives

Presenter: Katherine Trivedi

October 24, 2023

Presentation TCT 2023

Overcoming the "Credibility Crisis" of Observational Data

Presenter: Robert Yeh

October 24, 2023

Presentation TCT 2023

The FDA Total lifecycle Advisory Program (FDA-TAP)

Presenter: April Marrone

October 24, 2023

Presentation TCT 2023

Understanding the New Technology Add-on Payments Program (NTAP)

Presenter: Dominic Allocco

October 24, 2023

Presentation TCT 2023

Status Update on the Breakthrough Device Transitional Coverage for Emerging Technologies Program (TCET)

Presenter: Steven Farmer

October 24, 2023

Presentation TCT 2023

State of the FDA CDRH: Challenges, Opportunities, and Future Projections for Device Innovation, Approval, and Implementation

Presenter: Bram Zuckerman

October 24, 2023

Presentation TVT 2022

Post-Approval Safety Profile of Amulet vs Watchman FLX Left Atrial Appendage Closure Devices: Analysis from the MAUDE Database (ALERT-MAUDE Study)

Presenter: Poonam Velagapudi

June 10, 2022

Presentation TCT 2020

Regulatory Viewpoints on MCS Device Approval

Presenter: Meir Shinnar

October 16, 2020

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TCT 732: Peri-device Leak and Clinical Outcomes After LAAC Using a Fluoropolymer Coated Device in Patients with Paroxysmal vs. Persistent Atrial Fibrillation: HEAL-LAA Post Approval Study Sub-analysis

Electrosurgical Tools in Structural Heart Interventions: How to Drive Best Practices, Device Development, and Regulatory Approval

TCT 704: Outcomes After LAAC Using a Fluoropolymer Coated Device in Patients of Historically Underrepresented Racial and Ethnic Groups: A Sub-analysis of the HEAL-LAA Post Approval Study

Comparative Outcomes of ICE vs. TEE Guided LACC with Amulet Device: Insights from EMERGE LAA Post-Approval Study

Outcomes of TEE vs. ICE-guided Left Atrial Appendage Closure Using a Fluoropolymer Coated Device: A Sub-analysis of the HEAL-LAA Post Approval Study

Outcomes in Patients Discharged on OAC vs. DAPT After Left Atrial Appendage Occlusion Using a Fluoropolymer Coated Device: A Sub-analysis of the HEAL-LAA Post Approval Study

Outcomes of Same-day vs. Delayed Discharge After LAAC Using a Fluoropolymer Coated Device: HEAL-LAA Post Approval Study Sub-analysis

Left Atrial Appendage Closure with a Novel Fluoropolymer-Coated Device: The HEAL-LAA Post-Approval Clinical Study

Patient and Device Selection Following Commercial Approval of TTVI Devices: European Perspectives

PROs Alone in Non-Blinded Studies Shouldn’t Drive Device Approval

Clinician Perspectives

Industry Perspectives

FDA Perspectives

Overcoming the "Credibility Crisis" of Observational Data

The FDA Total lifecycle Advisory Program (FDA-TAP)

Understanding the New Technology Add-on Payments Program (NTAP)

Status Update on the Breakthrough Device Transitional Coverage for Emerging Technologies Program (TCET)

State of the FDA CDRH: Challenges, Opportunities, and Future Projections for Device Innovation, Approval, and Implementation

Post-Approval Safety Profile of Amulet vs Watchman FLX Left Atrial Appendage Closure Devices: Analysis from the MAUDE Database (ALERT-MAUDE Study)

Regulatory Viewpoints on MCS Device Approval

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