NCHR Testimony at 2016 FDA Meeting on Leadless Cardiac Pacemakers

February 18, 2016. Leadless pacemakers have the potential to improve the care of patients with various cardiac rhythm disorders. However, this will require an understanding of how acute adverse events compare and contrast with those of traditional pacemakers. I encourage you to urge the FDA to require comprehensive data regarding the intermediate and long-term safety and effectiveness of leadless pacemakers. Post approval studies should clearly assess these diverse factors. They should provide context regarding the entire spectrum of safety and effectiveness in a way that enables physicians to make sound decisions, and that allows patients to fully and clearly understand the risks and benefits of this new technology.

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