First Cardiac Contractility Modulation Device Approved by FDA

Most cardiac implants, such as pacemakers and AICDs, are designed to correct the underlying heart’s rhythm, and synchronize atrial and ventricular contractions. That’s how these devices can improve cardiac performance in people with heart failure. They don’t do anything to boost the intrinsic myocardial contractility of the heart. Now the FDA has just given approval to the first implant that actually uses electrical pulses to improve how hard the heart pushes blood through the body.

The Optimizer Smart system from Impulse Dynamics, a company out of Orangeburg, New York, is implanted like any cardiac implant, but it uses a total of three electrode leads that are attached to the heart. It delivers what the company calls Cardiac Contractility Modulation (CCM), which involves sending non-excitatory pulses during the absolute refractory period of the heart cycle, in turn improving the systolic contraction of the heart muscle.

It is indicated for patients with chronic, moderate-to-severe heart failure that are not candidates for other electrical modulation implants. It can improve the walking distance, quality of life, and functional status of patients for whom this therapy is effective. It is important that the patients have a normal heart rhythm, not be candidates for cardiac resynchronization therapy, and have a left ventricular ejection fraction of 25% to 45%.

“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,” in a statement said Professor William T. Abraham, MD, a 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.”

Here’s some details, according to the FDA, about what led to the approval:

The FDA evaluated data from two randomized, multi-center clinical trials with a total of 389 patients with moderate-to-severe heart failure. All patients received optimal medical therapy and 191 patients also received an Optimizer Smart system implant. Patients receiving the implant showed improvements in the distance they were able to walk in six-minute walking tests and improvements on standard assessments to measure heart failure symptoms, such as how much the symptoms affect a patient’s quality of life and how much the symptoms impede daily physical activities compared to those who received only medical therapy.

More from Impulse Dynamics:

CCM is the brand name for Cardiac Contractility Modulation, the non-excitatory electrical pulses delivered by the implantable Optimizer device during the absolute refractory period of the heart cycle to improve systolic contraction of the heart. The Optimizer System has been implanted in over 3,500 patients and is currently available in Europe, China, Brazil, India, and more than 40 other countries around the world. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials. The results have been published in over 80 papers in leading medical journals.

Here’s a video from Impulse Dynamics explaining the implantation and workings of the system:

Product page: Optimizer System…

Via: FDA and Impulse Dynamics…

JACC: Heart Failure: A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation…