EBR Systems has announced the CE mark approval for its Wise (Wireless stimulation endocardially) technology, which is the world’s only wireless endocardial pacing system for cardiac resynchronisation therapy (CRT).
The Wise 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, according to the company, may potentially be more effective than current epicardial pacing techniques.
EBR Systems has announced that during the next 12 months it will continue working with leading European clinicians to assess different strategies for optimising endocardial pacing location that maximise CRT benefits.
Preliminary results of the recently completed SELECT-LV study, which evaluated the safety and efficacy of the Wise technology, were presented by Vivek Reddy (Mount Sinai Hospital, New York, USA) at the Heart Rhythm Society 2015 Scientific Sessions in Boston, USA.
The study enrolled 35 patients who had failed conventional CRT therapy, of those 97% were implanted successfully with the Wise technology. Twenty-six of them had reached the six-month effectiveness endpoint, with 81% improving their clinical composite score. 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 resynchronisation implants,” says Allan Will, CEO EBR Systems. “We look forward to working with leaders in the European clinical community to further characterise the benefits of wireless endocardial pacing.”
The Wise technology consists of a tiny electrode implanted in the left ventricle. With every heartbeat it receives a synchronised ultrasound signal from a small transmitter placed between two ribs. Those sound waves are converted to electrical energy, providing cardiac pacing.
In June 2015, the technology was awarded Favourite Innovation winner at the EHRA EUROPACE – CARDIOSTIM Congress in Milan, Italy.