THT 2022 - The Clinical Story of Cardiac Contractility Modulation: Looking Ahead to the HFpEF Population
By
CCM® Therapy
FEATURING
Javed Butler
By
CCM® Therapy
FEATURING
Javed Butler
In this presentation from a sponsored session at the Technology and Heart Failure Therapeutics meeting on February 2, 2022, Dr. Javed Butler reviews the clinical data that resulted in CCM® therapy receiving Breakthrough Designation as well as subsequent FDA approval in 2019. He further expounds upon the rationale and data that support the use of CCM® therapy in patients with higher EF and describes the recently launched AIM HIGHer trial which addresses the large unmet need for the population of symptomatic heart failure patients with EF 40-60%. AIM HIGHer, with Dr. Butler as the study’s National Primary Investigator, will enroll 1500 patients from 150 US centers in a quadruple-blinded, sham-controlled, randomized trial (the largest such trial of an implantable cardiac therapy device) with endpoints including cardiovascular mortality, heart failure hospitalization, and health status. The first sites were activated in February 2022.
- October 26, 2021 - U.S. Food and Drug Administration approved a modification of labeling for the Optimizer® Smart medical device, allowing the removal of “normal sinus rhythm” (NSR) from the indications for use statement as of 10/26/2021. Please note that this presentation was done prior to this FDA update.
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