CCM® Therapy

Impulse Dynamics is determined to improve the lives of people with heart failure and is the developer of the innovative Optimizer® CCM® Therapy delivery system. CCM Therapy is a breakthrough heart failure treatment proven to improve quality of life for heart failure patients. CCM Therapy is specifically designed to improve systolic contraction in an effort to deliver more oxygen-rich blood to the body. CCM Therapy is a safe and effective, minimally invasive treatment option for millions of heart failure patients who otherwise have few or no effective options available to them. Optimizer® is the first and only FDA-approved device in the U.S. or elsewhere for the delivery of CCM Therapy.

Our mission at Impulse Dynamics is to exceed the expectations of patients, clinicians, and caregivers alike by developing and providing cardiac contractility modulation. The company believes in fostering innovation, transparency, and accountability in our relentless efforts to expand global access to the benefits of CCM Therapy.

www.impulsedynamics.com


 

THT 2022 - The Clinical Story of Cardiac Contractility Modulation: Looking Ahead to the HFpEF Population

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February 16, 2022
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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Heart Failure