Author + information
- aGeisel School of Medicine at Dartmouth, Hanover, New Hampshire
- bSection of Cardiovascular Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
- cDivision of Cardiovascular Medicine, College of Medicine at the Ohio State University, Columbus, Ohio
- ↵∗Address for correspondence:
Dr. Emily P. Zeitler, Cardiac Electrophysiology, Dartmouth-Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, The Dartmouth Institute, 1 Medical Center Drive, Lebanon, New Hampshire 03756.
• Heart failure represents an active area of novel medical device development.
• Baroreflex activation therapy, interatrial shunts, and phrenic nerve stimulation are emerging technologies in heart failure.
• Along with novel mechanisms of action and design, heart failure devices have demonstrated regulatory innovation.
• Lessons learned in development of heart failure devices may apply to other therapeutic areas.
The substantial burden of heart failure has inspired innovation in medical device development for decades, and this development continues to be a touchstone in the success story of combined medical and device therapy. Recently, baroreflex activation therapy, interatrial shunts, and phrenic nerve stimulation have shown promise in treating patients with heart failure. We seek to provide background about the design, function, and early clinical experience with these 3 novel heart failure devices. In addition, an understanding of the individual regulatory journey of these devices, some of which is ongoing, is informative for future device development and clinical use.
Dr. Abraham has served as a consultant to CVRx, Respicardia, and Impulse Dynamics; and serves as Chief Medical Officer of V-Wave Ltd. Dr. Zeitler has reported that she has no relationships relevant to the contents of this paper to disclose.
- Received May 15, 2019.
- Revision received October 28, 2019.
- Accepted November 4, 2019.
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.