SUNNYVALE, Calif., July 22, 2019 /PRNewswire/ -- EBR Systems, Inc., developer of the world's only wireless cardiac pacing system for heart failure, today announced that the College of the French National Authority for Health (Haute Autorite de Sante, HAS) awarded a Forfait Innovation Package for the company's WiSE™ Cardiac Resynchronization Therapy (CRT) System. The award, worth up to €1 million, will help treat as many as 40 patients and support the SOLVE CRT global clinical study. It has started enrolling heart failure patients in France at CHU Grenoble Alpes, APHM Hôpital de La Timone (Marseille), CHU Rennes - Pontchaillou and Clinique Pasteur (Toulouse). Patients are non-responders to, or unable to receive, conventional CRT.
The Forfait Innovation funding mechanism was established by the Ministry of Social Affairs and Health to fast track the provision of innovative healthcare technologies to French patients, while collecting data to support a longer-term reimbursement decision. This funding is only awarded to select medical technologies that demonstrate breakthrough innovation and hold potential for significant clinical benefits.
The CE Mark-approved WiSE CRT system is the first and only implantable cardiology device to receive this innovation funding in France to date. The provision of this funding will ensure that qualifying heart failure patients within France will receive early access to this promising technology.
"We are excited to have implanted the first SOLVE CRT patient in France and are encouraged by the support of the Ministry of Social Affairs and Health for the use of this approach in our patients," commented Professor Pascal Defaye, MD of Centre Hospitalier Universitaire de Grenoble. "We hope that the current study confirms the results of earlier clinical evaluations of this approach."
"We are thrilled that the Ministry has chosen to provide such an honor to the WiSE CRT System following the assessment of the team at the Haute Autorite de Sante," said Allan Will, Executive Chairman of EBR Systems. "We hope this award will enable many deserving patients in France to receive this life-changing therapy."
The SOLVE CRT Study began in early 2018. It will enroll up to 350 randomized worldwide and is expected to complete enrollment in mid-2020.
About Heart Failure and Cardiac Resynchronization Therapy (CRT) Heart failure is a serious condition in which the heart is unable to pump enough blood to meet the body's demands. A progressive, debilitating disease, heart failure often occurs when electrical signals within the heart are disrupted, causing the heart's ventricles to beat in an uncoordinated or unsynchronized pattern that enlarges the left ventricle and makes the heart less efficient.
Cardiac resynchronization therapy is a proven treatment that improves symptoms and reduces hospitalizations and mortality1,2 by electrically stimulating the heart. Also referred to as biventricular pacing, CRT uses wire leads to synchronize the left and the right ventricles so that the two chambers beat together, thereby improving the heart's efficiency. Approximately 200,000 patients are treated worldwide each year with traditional CRT.3
EBR Systems' WiSE Technology Approximately 30 percent of patients receiving conventional CRT do not respond to the therapy. A major cause of this shortcoming is believed to be the inconsistency of results achieved using wire leads to pace the left ventricle from within the coronary sinus vein on the epicardial (exterior) surface of the heart. Although it is generally accepted that stimulation of the left ventricle is preferable from inside the heart (endocardially), wire leads placed inside the left ventricle can cause clots, heart attacks or strokes. Additionally, wire leads can break, dislodge or otherwise fail, leading to complications in roughly 12 percent of cases.4 The financial impact of these issues is profound. More than $1 billion of $3.5 billion spent annually on CRT devices provides no patient benefit.5
EBR Systems' WiSE CRT System 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.
The WiSE™ CRT System 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 Brandon Capital Partners, M.H. Carnegie & Co., Split Rock Partners, Ascension Ventures and Emergent Medical Partners.
1 McAlister FA, Ezekowitz J, Hooton, N, et al. Cardiac Resynchronization Therapy for Patients with Left Ventricular Systolic Dysfunction: A Systematic Review. JAMA. 2007; 297(22): 2502-14. 2 Abraham WT, Fisher WG, Smith AL, et al. Cardiac Resynchronization in Chronic Heart Failure. N Engl J Med. 2002; 346: 1845-53. 3 JP Morgan, Cardiac Rhythm Management (CRM) Market Model, August, 2017, Michael Weinstein 4 Leon AR, Abraham WT, Curtis AB et.al. Safety of Transvenous Cardiac Resynchronization System Implantation in Patients with Chronic Heart Failure. J Am Coll Cardiol. 2005; 46: 2348-56. 5 Poole JE, Gleva MJ, Mela T, et.al. Complication Rates Associate with Pacemaker or ICD Generator Replacements and Upgrade Procedures. Circulation. 2010;122:1553-1561.)