This workshop is intended to bring together the FDA, CMS, Industry, and clinical site partners to discuss how to implement EFS trials. It will provide a half day of presentations delivered by recognized thought leaders in the medical device ecosystem. The agenda will consist of lectures and engage in high level panel discussions focused on EFS in Electrophysiology.

View the Agenda Brochure!

Agenda - Rejuvenating the U.S. Electrophysiology Clinical Trial Ecosystem: EP Early Feasibility Studies Best Practices Workshop

Marquee Room - Omni Hotel at Boston Seaport

1:00 PM Welcome

Pete Weiss, MD and Justin Klein, MD, JD

1:10 PM History of the Early Feasibility Pathway for Novel Medical Devices

Andrew Farb, MD (FDA)

1:15 PM MDIC led Transformation of the Structural Heart Regulatory Pathway: The Return of Early Feasibility Studies to the U.S.

Chip Hance

1:20 PM Session I: The Evolving Regulatory Pathways for Novel EP Devices

Session Leaders

Ken Stein, MD and Vivek Reddy, MD

Speakers

Vivek Reddy, MD – “Trends in Electrophysiology Clinical Studies and the Need for an Effective Clinical Trial Ecosystem”

Kit Schneider – “Farapulse: Clinical and Regulatory Journey”

Ken Coffey – “An EP Startup’s Perspective on the Clinical Pathway”

George VanHare, MD – “FDA Perspectives on Electrophysiology Clinical Studies”

Jerome Kalifa, MD, PhD – “Early

Feasibility Clinical Evidence: Using the US-EU Regulatory Paradigms to Advance Innovative Technologies: The Volta Medical Experience”

1:55 PM | Open Discussion / Q&A

2:30 PM | Break

2:45 Session II: EFS and the Bridge to Pivotal – Clinical Site Experience

Session Leaders: Tony Hong, MD (Biosense Webster) and Devi Nair, MD (Saint Bernards Healthcare)

Speakers:

Site Learnings: Devi Nair, MD (Saint Bernards Healthcare) – “Conducting Early EP Clinical Research in the U.S.: A Clinical Site Success Story”

Samuel Asirvatham, MD (Mayo Clinic) “Promoting Innovation through EFS”

Site Learnings: Moussa Mansour, MD (Mass Gen) – “Ambitions and challenges in conducting early research in the U.S.”

Site Learnings: Amin Al-Ahmad, MD – “Ambitions and challenges in conducting early research in the U.S.”

Aaron Kaplan, MD (Dartmouth/Conformal) – “A Sponsor’s Perspective: Utilizing the EFS Pathway for a Novel Electrophysiology Device”

Avi Fischer, MD (Orchestra BioMed Inc.)– “Considerations as a Study Sponsor Bringing an EFS to the U.S.”

Holger Friedrich, MD (AQUAHeart) – “Quality Enrollment is Essential, But Time is Money”

3:20 PM | Open Discussion / Q&A

3:50 PM | Break

4:05 PM | Session III: Shortening Time to First Patient In: Timely and Effective Contracting

Session Leaders: Jaime Walkowiak, JD (Temporis Consulting)

Speakers:

Jaime Walkowiak, JD (Temporis Consulting) – “Yes We Can Negotiate Contracts in 60 Days!”

Kate Dalton (Columbia) – “Institutional Alignment in a Teaching Hospital for Early Feasibility Studies”

Lynne Goodreau (NMH) – “10 Successful EFS Studies and Counting at a Leading Clinical Site – It can be Done”

Brad Horst (Boston Scientific) – “Tips and Tricks of Contract Negotiation from a Sponsor’s Point of View”

David Hazelwood, PhD (FDA) – ““FDA Categorization of IDE Applications to Assist CMS Coverage Decisions"

4:35 PM | Open Discussion / Q&A

5:05 PM | Wrap Up and Closing Remarks:

Pete Weiss, MD (Banner Health) and Justin Klein, MD, JD (Vensana Capital)

Summary of Next Steps

Eileen Mihas (MDIC)

Contemporary Room - Omni Hotel at Boston Seaport

5:30 PM | Cocktail Networking Reception

6:30-8:30 PM | Dinner

Keynote Speaker

Bram Zuckerman, MD