EBR Systems, Inc. Initiates Global Trial of World’s Only Wireless CRT Pacing Technology

Tiny Wireless Electrode Potentially Expands Heart Failure Therapy

SUNNYVALE, Calif.--(BUSINESS WIRE)--EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced enrollment of the first patients in the global SOLVE-CRT (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy) clinical trial.

The first patients were enrolled by Prof. Dr. Christian Butter at Immanuel Klinikum Herzzentrum Brandenburg in Bernau, Germany; Dr. Jeffrey Alison at Monash Heart in Clayton, VIC, Australia; Dr. John Ip at Sparrow Health System in Lansing, Michigan, U.S.A.; and by Dr. Tim Betts at Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, U.K.

SOLVE-CRT is a randomized, double blinded, prospective pivotal trial intended to assess safety and efficacy of the WiSE™ (Wireless Stimulation Endocardially) pacing technology in support of U.S. Food and Drug Administration (FDA) approval. The study will enroll 350 heart failure patients who have failed to respond to, or are otherwise unable to receive, conventional cardiac resynchronization therapy (CRT). The study will take place at up to 45 U.S., European and Australian investigational sites.

The WiSE CRT System is designed to improve the heart’s pumping ability and help overcome symptoms of heart failure. Rather than using pacing leads — decades‐old technology with well‐documented problems — WiSE paces the heart via a tiny wireless electrode, the size of a grain of rice, implanted directly in the heart’s left ventricle. This approach provides the cardiologist greater choice of pacing locations, enabling patient-specific customization of pacing site.

Additionally, endocardial (inside the heart) placement of the electrode is believed to be more physiologic than the traditional epicardial (outside the heart) approach. The combination of endocardial pacing and patient-specific electrode positioning may be more effective than today’s systems. The WiSE system works together with a previously implanted pacemaker or implantable cardioverter defibrillator (ICD) that paces the right side of the heart.

“Wireless pacing promises to address an important unmet need for patients with heart failure. Studies have demonstrated successful cardiac resynchronization therapy improves symptoms and reduces hospitalizations and mortality, but many patients do not respond to traditional CRT devices and have limited therapeutic options,” said Jagmeet P. Singh M.D., Ph.D., of Massachusetts General Hospital in Boston, Mass, who serves as the study’s global principal investigator. “I am excited to lead this important trial to hopefully confirm earlier promising results in a larger population and demonstrate WiSE CRT’s potential as a new option for patients who would otherwise face progressive deterioration of their condition and repeated hospitalizations.”

Cardiac resynchronization therapy offers a proven treatment for heart failure, but as many as 30 percent of heart failure patients receiving conventional CRT do not respond to the treatment. Without CRT, people with heart failure deteriorate and may eventually die of the condition. For many, medicine only helps to a limited degree.

“We believe SOLVE-CRT to be a landmark study that will build on previous positive results of this first-of-its-kind innovation for heart failure patients,” said Allan Will, chairman and CEO of EBR Systems. “We are thrilled to have the participation and enthusiasm from so many world-class sites, who are motivated to expand the benefits of CRT therapy to patients who currently have no promising therapeutic alternatives.”

Results of SELECT-LV, a multicenter European prospective trial involving 39 patients in six hospital centers, demonstrated sustained cardiovascular improvement for complex CRT patients treated with the WiSE CRT System, with the majority of patients experiencing persistent clinical benefits at six months. Clinical benefits included patient freedom from mortality and heart failure hospitalizations and improvement in quality of life and functional capacity.

The WiSE™ CRT System received European CE Mark approval for its second-generation wireless transmitter and has enabled treatment for many patients who had previously failed treatment with conventional CRT devices.

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, which in turn enlarges the left ventricle and makes the heart less efficient.

Without therapy, people with heart failure deteriorate and may eventually die of the condition. Cardiac resynchronization therapy offers a proven treatment that improves symptoms and reduces hospitalizations and mortality2,3 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 and about 155,000 of them are in the U.S.

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.5 The financial impact of these issues is profound. As much as $1 billion of $3.5 billion spent annually on CRT devices provides no patient benefit.

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.