Impulse Dynamics has enrolled the first patient in a post-approval study of the Cardiac Contractility Modulation therapy, which is delivered by the Optimizer system. The move comes a few months after the private firm raised $80.3 million in a series D round.
The MT. Laurel, N.J.-based company said the post-approval study will evaluate the real-world evidence of the therapy’s safety and efficacy for three years. About 620 patients from heart centers across the U.S. will be enrolled in the study.
The first patient was enrolled by Charles Jost, MD, interventional cardiologist and principal investigator at Southwest Cardiovascular Associates in Mesa, AZ.
“Before the Optimizer system was introduced, many of my heart failure patients had few, or no effective options to improve their quality of life available to them,” said Dr. Jost. “The positive clinical outcomes for patients treated with this therapy are impressive and it has given many of my patients a reason to be hopeful again. I am pleased to participate in this study because it seeks to further substantiate the compelling portfolio of clinical evidence that supported the Optimizer system’s FDA approval in actual clinical practice over time.”
The firm’s technology delivers Cardiac Contractility Modulation (CCM). Through CCM an electrical pulse is delivered during the absolute refractory period, which is just after heart contracts. In contrast to a pacemaker or defibrillator, CCM works by modulating the strength of the heart muscle contraction rather than the rhythm.
The Optimizer Smart device received breakthrough device designation in 2015 and eventually won FDA approval in March of 2019. The technology went before the Circulatory System Devices Panel of the Medical Devices Advisory Committee, Dec. 4, 2018, receiving a 12-0 vote on the benefit-to-risk ratio of the device.