EBR Systems, a leading innovator in wireless heart stimulation, has received European CE Mark for its WiSE (Wireless Stimulation Endocardially) Technology.
According to the company, EBR Systems' WiSE Technology is the world's only wireless endocardial pacing system for cardiac resynchronization therapy (CRT).
CE Mark approval gives EBR Systems the ability to train and educate physicians in the European Union on the use of the WiSE System. It will help more patients to benefit from this innovative therapy.
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.
The results were highly positive. "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."
The WiSE Technology is leadless, completely eliminating the want for a pacing wire in the left ventricle. The technology consists of a tiny electrode implanted in the left ventricle. With every heartbeat it gets a synchronized ultrasound signal from a small transmitter placed between two ribs. Those sound waves are converted to electrical energy, providing cardiac pacing.