EBR Systems has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to start the pivotal trial of wireless stimulation endocardially (WiSE) for cardiac resynchronization therapy (CRT).
WiSE technology is claimed to be the only wireless and endocardial pacing system that can stimulate the left ventricle of the heart.
The IDA approval enables the company to begin the 350-patient stimulation of the left ventricle endocardially–CRT study (SOLVE-CRT).
According to the company, the study will be a prospective and randomized controlled trial using generally-accepted measures of safety and efficacy as primary endpoints at six months.
The firm plans to initiate the clinical trial in mid-2017.
WiSE wireless cardiac pacing system includes a tiny electrode that will be implanted in the left ventricle. With every heart beat, it secures a synchronized ultrasound signal from a small transmitter placed between two ribs.
These sound waves will be converted to electrical energy, which will provide cardiac pacing.
WiSE cardiac pacing system received CE mark approval to treat heart failure in Europe
EBR is also planning to introduce its second generation WiSE technology in Europe in early 2017.
EBR Systems CEO Allan Will said: “A growing body of evidence strongly suggests EBR’s WiSE Technology can benefit patients who have failed conventional cardiac resynchronization implants.
“We look forward to demonstrating the benefits of WiSE Technology for these patients in the first randomized clinical study of wireless endocardial pacing for heart failure.”
Image: The WiSE CRT system uses a tiny implant in the left ventricle to synchronize the heart. Photo: courtesy of Business Wire.