Impulse Dynamics Announces Successful Implantation of First Patient Since FDA Approval of Optimizer® Smart System
First-in-class device delivers CCM™ therapy to address significant unmet medical need in heart failure
NEW YORK, May 8, 2019 /PRNewswire/ -- Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCM™ therapy, announced today that the first patient to receive the Optimizer Smart System since the device was approved by the U.S. Food and Drug Administration was successfully implanted. The procedure, which occurred on Monday, May 6, at The Ohio State University Wexner Medical Center, took less than an hour to complete and the patient was able to go home the next day.
In addition to conducting the first implant, The Ohio State University Wexner Medical Center played an integral part in the clinical testing of the Optimizer Smart System. William T. Abraham, MD, professor of medicine, physiology, and cell biology, and College of Medicine Distinguished Professor at Ohio State Wexner Medical Center, was the lead investigator on the clinical trial that demonstrated its safety and efficacy in heart failure patients.
The Optimizer Smart 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 who remain symptomatic despite guideline directed medical therapy, who are in normal sinus rhythm, are not indicated for CRT, and have an LVEF ranging from 25% to 45%. Only 30 percent of moderate to severe chronic heart failure patients are candidates for CRT, which historically has left 70 percent of patients with few options to help them manage their disease.
"Previously, we had a gap in care for heart failure patients who were not candidates for CRT and were too sick for drug therapy alone, but were not sick enough to warrant a left ventricular assist device," said Raul Weiss, MD, professor of clinical medicine and director of the electrophysiology fellowship program at Ohio State Wexner Medical Center, who implanted the device. "This is an important advancement in the treatment of these patients."
The patient, a 69-year-old man, was diagnosed with heart failure five years ago. Despite receiving optimal drug therapy, the patient's heart failure progressed and required additional intervention, but he was not a candidate for CRT.
"This was the ideal patient to benefit from assistance in strengthening the heartbeat," said Rami Kahwash, MD, associate professor of internal medicine and director of the Heart and Vascular Research Organization at Ohio State Wexner Medical Center. "Without this device implant, the patient would have eventually become too sick to engage in any day-to-day activities and we would have been forced to consider more invasive and aggressive interventions."
The Optimizer Smart System administers Impulse Dynamic's proprietary CCM therapy to the heart. 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. In the most recent study of the Optimizer Smart System, 81.5 percent of patients experienced at least one full class improvement in their New York Heart Association functional classification after receiving CCM therapy.
"This is a significant milestone for Impulse Dymanics – one the company has been working toward for several years now," said Christopher Baer, Vice President of Commercial Operations, Impulse Dynamics. "This technology has the potential to change the lives of many heart failure patients across the U.S., and we will continue to celebrate every patient who is able to go home feeling better than they did before."
About the Optimizer and CCM Therapy
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.
About Impulse Dynamics
Impulse Dynamics is focused on the development of electrical therapies for the treatment of chronic heart failure. As a global leader in cardiac medical innovation, Impulse Dynamics has operations in the United States, Europe, and Asia. For more information please visit www.impulse-dynamics.com.
SOURCE Impulse Dynamics
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