FDA Approves New Device for Treating Heart Failure

According to FDA, about 5.7 million people in the United States have heart failure, a condition in which the heart cannot pump enough blood to meet the body's needs.

The U.S. Food and Drug Administration on March 21 approved Impulse Dynamics' implantable Optimizer® Smart System for delivering CCM™ therapy, for treating patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronization therapy to restore a normal timing pattern of the heartbeat. FDA gave the device a Breakthrough Device designation because it treats a life-threatening disease, heart failure, and addresses an unmet medical need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options.

"Patients with moderate-to-severe chronic heart failure have limited treatment options. And for those who are unable to be treated due to underlying conditions or who have not responded to available treatments, their quality of life may be impacted, with limits on the types of physical activities they can do," said Dr. Bram Zuckerman, director of the Division of Cardiovascular Devices in FDA's Center for Devices and Radiological Health. "The FDA recognized the unmet need for these patients and worked with the manufacturer through our Breakthrough Device Program to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness."

According to FDA, about 5.7 million people in the United States have heart failure, a condition in which the heart cannot pump enough blood to meet the body's needs. The leading causes of heart failure are diseases that damage the heart, such as high blood pressure and diabetes.

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.

"With the FDA's approval of the Optimizer System for the delivery of CCM, we finally have available in the U.S. 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, M.D., 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 U.S. who previously did not have access to this therapy. As such, it represents a real game-changer for these patients."

"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," added 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."

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.

Dr. Simos Kedikoglou, Impulse Dynamics' CEO, said the company will launch the device in the United States later this year.

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