Impulse Dynamics receives FDA approval for the First Ever Optimizer Smart System for Delivering CCM Therapy

Pacemakers are designed to monitor and record the rate and rhythm of the heart.

Image credit: JACC

Pacemakers are designed to monitor and record the rate and rhythm of the heart and make sure the heart rate doesn’t get too slow. An ICD acts as a pacemaker, but it can also detect dangerously fast heart rates, called ventricular tachycardia or ventricular fibrillation, and stop them. However, these devices don’t do anything to improve the heart’s innate ability to contract. Now, Impulse Dynamics’ Optimizer® Smart System for delivering cardiac contractility modulation (CCM) Therapy has received approval from FDA. The system is the first and only CCM device approved by the FDA to improve 6-minute hall walk distance, quality of life and functional status of NYHA Class III heart failure patients.

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“With the FDA’s approval of the Optimizer System for the delivery of CCM, we finally have available in the US an effective device-based therapy for advanced heart failure patients with mildly to moderately reduced left ventricular ejection fractions who are not eligible for CRT,” said Professor William T. Abraham, MD, Professor of Medicine, Physiology, and Cell Biology, and College of Medicine Distinguished Professor at the Ohio State University Wexner Medical Center. “The Optimizer System, along with guideline-directed medical therapies, can improve the lives of many heart failure patients in the US who previously did not have access to this therapy. As such, it represents a real game-changer for these patients.”

CCM is a unique electrical pulse delivered during the absolute refractory period, which is just after the heart contracts. In contrast to a pacemaker or defibrillator, CCM works by modulating the strength of the heart muscle contraction rather than the rhythm, reports Impulse Dynamics.

“FDA approval is the culmination of many years of clinical development for this disruptive technology, addressing a significant unmet need in today’s heart failure treatment paradigm,” commented Dr. Daniel Burkhoff, Impulse Dynamics’ Medical Advisor. “We continue to develop the technology with ongoing clinical trials designed to evaluate CCM therapy in additional heart failure populations.”

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Impulse Dynamics develops electrical therapies for the treatment of chronic heart failure. The company has operations in the United States, Europe, and Asia.

Sam Draper
March 25, 2019

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