Sunday December 6th: 1:30 – 3:30 pm
Heart failure continues to represent a substantial burden among CV diseases. This has inspired innovation in medical device development for decades. Along with novel mechanisms of action and design, heart failure devices have resulted in innovation in regulatory approval processes.
This session will be chaired by Dr. Nicole Ibrahim, Director of the Division of Circulatory Support, Structural and Vascular Devices at the Center for Devices and Radiological Health, FDA in Maryland, USA, and Dr. JoAnn Lindenfeld, Director of Heart Failure and Transplant at the Vanderbilt University Medical Center in Nashville, TN, USA.
Dr. William Abraham, an expert in heart failure and transplant from the College of Medicine at the Ohio State University, Columbus, Ohio will provide a detailed look at recent controlled trials for heart failure devices. Specifically, he will provide an overview of the design, function, and early clinical experience with 3 novel heart failure devices: baroreflex activation therapy (BAT), interatrial shunts, and phrenic nerve stimulation. He will also discuss the individual regulatory journey of these devices, some of which are on-going, and how they can inform trials for future device development and clinical use.
Dr. Adrian Hernandez from the Duke University School of Medicine in Durham, NC, USA will discuss the role of remote monitoring devices in heart failure. With the COVID-19 pandemic continuing to have a negative impact on general and trial related CV care, remote monitoring is becoming a necessity. Adding to the value of this session are the additional viewpoints from industry (Daniel Burkhoff, HeartWare, USA, Kenneth Stein, Boston Scientific, USA, and Nadim Yared, CVRx, USA), , regulatory (Meir Sinnar, US FDA), and payers (Jason Bennett, CMS, USA).
The moderated multi-stakeholder’s debate titled, “Regulatory, Clinical, And Implementation Challenges for Breakthrough Heart Failure Devices”, will provide a wide range of viewpoints from the expanded panel, and we expect a lot of questions and discussion from participants at this session.
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