May 12, 2022 — Englewood Health is offering suitable patients access to a novel medical device demonstrated to improve heart failure symptoms.
The Optimizer® CCM® is a first-of-its-kind device designed to improve heart contractions, allowing more oxygen-rich blood to reach the body. The device accomplishes this by delivering cardiac contractility modulation (CCM), a kind of therapy that sends precisely-timed electrical impulses to the heart that strengthens the heartbeat.
The device is similar in size to a pacemaker and is implanted just under the skin of the upper chest during a minimally invasive procedure. Electrical leads are also placed in the heart’s right ventricle and, once there, deliver electrical impulses to the heart at regular intervals throughout the day and night.
The Optimizer CCM system was granted “Breakthrough Device” designation by the U.S. Food and Drug Administration (FDA), a label and expedited approval process given to emerging devices that offer significant advantages over existing alternatives or, as in the case for the Optimizer system, where there are no suitable alternatives available for a large population of patients.
“The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review while preserving the statutory standards for premarket approval,” the FDA reports.
The Optimizer CCM received this designation for its ability to cause subsequent heartbeats to be stronger and more forceful with the continued use of the device. Over time, the improvements in contraction have been shown to restore the heart to a more normal condition through a process known as reverse remodeling.
Heart failure affects an estimated 6.5 million Americans and nearly 64 million people worldwide. Patients with heart failure can experience symptoms that make everyday activities challenging, including breathlessness, fatigue, confusion, and swelling of the legs.
In clinical trials, the Optimizer CCM has demonstrated its capacity to enhance the quality of life for heart failure patients who no longer respond to medications meant to manage their symptoms.
“We welcome the opportunity to expand the options available to our cardiac patients and feel confident that the Optimizer CCM system will improve the lives of those who qualify for its use,” said David Y. Feigenblum, MD, medical director of the Implantable Defibrillator Center at Englewood Health.