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EBR Systems receives European CE mark approval for wireless cardiac pacing system for heart failure

EBR Systems announced European CE Mark (Conformité Européenne) approval for its WiSE (Wireless Stimulation Endocardially) Technology.

EBR Systems’ WiSE Technology is the world’s only wireless endocardial pacing system for cardiac resynchronization therapy (CRT). CRT is a treatment for heart failure that uses an implantable pacemaker to improve the heart’s pumping efficiency by synchronizing the left and right ventricles.

Studies have demonstrated successful CRT therapy reduces heart failure symptoms, hospitalizations and mortality. WiSE Technology could potentially benefit 1.5 million of these patients worldwide.

CE Mark approval gives EBR Systems the ability to train and educate physicians in the European Union on the use of the WiSE System, enabling more patients to benefit from this innovative therapy.

During the next 12 months, EBR Systems will continue working with leading European clinicians to assess different strategies for optimizing endocardial pacing location that maximize CRT benefits.

Preliminary results of the recently completed SELECT-LV study were presented in mid-May by Mt. Sinai Hospital cardiologist and Professor of Medicine Vivek Reddy, M.D., at the Heart Rhythm Society Scientific Sessions in Boston. In a study of 35 patients who had failed conventional CRT therapy, 97% were implanted successfully with WiSE Technology.

Twenty-six of them had reached the six month effectiveness endpoint, with 81 percent improving their clinical composite score which is a measure of symptom improvement. Nine patients had not yet reached the six month follow up.

"A growing body of evidence strongly suggests EBR’s WiSE Technology can benefit patients who have failed conventional cardiac resynchronization implants," said EBR Systems CEO Allan Will. "We look forward to working with leaders in the European clinical community to further characterize the benefits of wireless endocardial pacing."

CRT devices have been shown to improve left ventricular function and reduce morbidity and mortality in patients with cardiac synchronization problems. However, conventional CRT devices use wired leads to deliver pacing pulses to the left ventricle.

These wires can break or otherwise fail, leading to complications in roughly 5-10 percent of cases. The WiSE Technology is leadless, completely eliminating the need for a pacing wire in the left ventricle.

EBR Systems’ WiSE Technology consists of a tiny electrode implanted in the left ventricle. With every heartbeat it receives a synchronized ultrasound signal from a small transmitter placed between two ribs. Those sound waves are converted to electrical energy, providing cardiac pacing.

This unique technology eliminates the need for a left ventricular lead and is designed to let the physician place the stimulation point at an optimal, patient specific location inside the left ventricle (endocardially) which may potentially be more effective.

Endocardial stimulation is generally considered more like the natural activation pattern of the heart than today’s epicardial pacing techniques. Data from multiple sources strongly suggests this can benefit patients and is a potential major advance in left ventricular stimulation.

WiSE is the world’s first and only wireless cardiac pacing system for heart failure. In June 2015 it was selected Favorite Innovation winner at the annual EUROPACE CARDIOSTIM congress in Milan, Italy.