New Case Report Reveals Opportunity to Become First-Line Therapy for Patients
SUNNYVALE, Calif.–(BUSINESS WIRE)–EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced the publication of a case report demonstrating the WiSE™ CRT System’s ability to successfully deliver leadless Left Bundle Branch Area Pacing (LBBAP). WiSE is the only leadless pacing technology able to achieve LBBAP, a novel form of conduction system pacing which can reverse left bundle branch block and deliver cardiac resynchronization therapy (CRT).
Published last month in the European Heart Journal, the case report details the successful deployment of the WiSE Electrode implanted in the LV septum of an 82-year-old male with tachyarrhythmia-induced cardiomyopathy. The patient exhibited improved electrical resynchronization on ECG and reported significant symptomatic improvement at six-month follow-up. This is the first reported case of LBBAP delivered via the WiSE CRT system, and it is also the first reported case of permanent LBBAP from the LV aspect of the interventricular septum.
“EBR continues to pursue the feasibility of leadless LBBAP and the hope that the WiSE CRT system can benefit even more patients,” said John McCutcheon, President and CEO at EBR Systems. “We are committed to supporting an upcoming physician-initiated study to further investigate WiSE’s potential to deliver first-line therapy for patients.”
LBBAP pacing has been proposed as a strategy to achieve physiological pacing by utilizing the heart’s native conduction system, allowing faster left ventricular activation time.1 LBBAP has potential applications in both traditional bradycardia pacing and as an alternative approach to Cardiac Resynchronization Therapy (CRT).2 Until now, LBBAP has required use of a conventional pacing lead, driven deep into the ventricular septum, which can be technically challenging.3
“We are pleased to confirm WiSE’s ability to deliver leadless left bundle branch pacing in this new report,” said Professor Pascal Defaye, the Head of Rhythmology and Cardiac Stimulation Unit at CHU de Grenoble-Alpes, France, who performed the implant. “WiSE is the first and only leadless pacing system that can deliver physiologic, conduction system pacing without leads. Our initial case demonstrates the exciting potential of EBR’s technology.”
EBR Systems’ WiSE Technology
EBR Systems’ WiSE is the world’s only wireless, endocardial (inside the heart) pacing system in clinical use for stimulating the heart’s left ventricle. This has long been a goal of cardiac pacing companies since internal stimulation of the left ventricle is thought to be a potentially superior, more anatomically correct pacing location. WiSE Technology enables cardiac pacing of the left ventricle with a novel cardiac implant that is roughly the size of a large grain of rice. The need for a pacing wire on the outside of the heart’s left ventricle – and the attendant problems – are potentially eliminated.
WiSE is an investigational device and is not currently available for sale in the United States.
About EBR Systems
Silicon Valley-based EBR Systems is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. The company’s patented proprietary Wireless Stimulation Endocardially (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 company’s initial product is designed to eliminate the need for coronary sinus leads to stimulate the left ventricle in heart failure patients requiring CRT. Future products will address wireless endocardial stimulation for bradycardia and other non-cardiac indications. EBR Systems is backed by respected private equity investors including M.H. Carnegie & Co., Brandon Capital Partners, Split Rock Partners, Ascension Ventures and Emergent Medical Partners.
1 Zhang W, Huang J, Qi Y, et al. Cardiac Resynchronization Therapy by Left Bundle Branch Area Pacing in Patients with Heart Failure and Left Bundle Branch Block. Heart Rhythm. 2019; 16(12):1783-1790.
2 Padala SK and Ellenbogen KA. Left Bundle Branch Pacing is the Best Approach to Physiological Pacing. Heart Rhythm O2. 2020; 1(1):59-67.
3 Li X, Li H, Ma W, et al. Permanent Left Bundle Branch Area Pacing for Atrioventricular Block: Feasibility, Safety, and Acute Effect. Heart Rhythm. 2019;16:1766-1773.
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