SUNNYVALE, Calif., Oct. 26, 2023 /PRNewswire/ — EBR Systems, Inc. (ASX:EBR), the medical device company developing wireless cardiac pacing systems, is proud to announce that positive results from the first completely leadless cardiac resynchronization therapy (CRT) in the United States have been published in The Journal of American College of Cardiology (JACC).
The positive results published in JACC are based on a 1-year follow-up of the first-in-human implantation in the US of totally leadless CRT pacing utilizing the Micra™ leadless pacing system in the right ventricle in conjunction with EBR’s investigational WiSE® CRT Electrode in the left ventricle of the heart. At 12-months, the patient showed improved heart failure symptoms (NYHA Class III to II), no recurrent heart failure-related hospitalization, a reduction in QRS duration, and an improvement in left ventricular ejection fraction (LVEF) from 30% to 65%.
This first use in the US of the WiSE CRT System as a first-line therapy is a future market expansion opportunity for EBR. The initial addressable market of $2.6 billion is focused on treating patients who had previously failed CRT and by treating new CRT patients, the addressable market could increase to $6.8 billion.
Based on the patient’s health complications and risks, the implantation of EBR’s investigational WiSE CRT System alongside Medtronic’s Micra received requisite approval from the Institutional Review Board (IRB) and U.S. Food and Drug Administration (FDA) on compassionate grounds.
"Our research findings published in The Journal of the American College of Cardiology demonstrate the first reported application of this uniquely versatile option of CRT use in the United States," said Dr Dinesh Sharma, MD, the implanting physician and Section Head, Cardiac Electrophysiology at Naples Heart Institute, Florida. "The positive results witnessed during the one-year follow-up of the implantation, suggests that a broader cohort of patients can potentially reap the benefits of completely leadless resynchronization as these leadless pacemakers advance."
"There are challenges with conventional CRT devices, such as access issues or the inability to implant the coronary sinus lead in the target branch. In such situations, the leadless WiSE CRT System could be particularly beneficial. For this patient, the combination of Micra and the WiSE CRT System was the best option to achieve positive outcomes," Dr Sharma added.
"It’s great to see these positive results being published in a world-leading cardiology journal, such as The Journal of the American College of Cardiology," said John McCutcheon, President & CEO of EBR Systems. "This case study highlights the potential of totally leadless CRT for patients struggling with traditional CRT, but also beyond these patient groups, the 64 million heart failure patients across the globe."
"Leads are the Achilles heel of the pacing industry. We view a biventricular approach to CRT, demonstrated in this case study as the future of pacing systems and consequently a major growth driver for EBR," McCutcheon added.
The Journal of the American College of Cardiology (JACC) is a prestigious, peer-reviewed medical
journal dedicated to the field of cardiology. As a leading publication in the cardiovascular sciences, JACC provides a platform for the dissemination of research, clinical studies, and breakthroughs in cardiovascular medicine.
The WiSE® CRT System has the potential to offer a new treatment option for patients including the 3 million heart failure patients worldwide who were previously untreatable by conventional CRT, and potentially, the 64 million heart failure patients across the globe.
The full article in The Journal of the American College of Cardiology can be accessed here: https://www.sciencedirect.com/science/article/pii/S2666084923003534?via%3Dihub
About EBR Systems (ASX: EBR)
Silicon Valley-based EBR Systems (ASX: EBR) is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. The patented proprietary Wireless Stimulation Endocardial (WiSE) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications and reliability issues in cardiac rhythm disease management. The initial product is designed to eliminate the need for coronary sinus leads to stimulate the left ventricle in heart failure patients requiring Cardiac Resynchronization Therapy (CRT). Future products potentially address wireless endocardial stimulation for bradycardia and other non-cardiac indications.
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