EBR Systems has secured an Investigational Device Exemption (IDE) for its Wireless Stimulation Endocardially (WiSE) Technology for cardiac resynchronisation therapy (CRT), from the US Food and Drug Administration (FDA).
The IDE will enable EBR Systems to start a major US study to establish safety and effectiveness in support of US approval.
Harvard Medical School Associate Chief of Cardiology and Professor of Medicine, principal investigator for the planned study Jagmeet Singh said: “WiSE is unique, significant technology that’s cleared for use in Europe and has proven very beneficial thus far.
“This important medical advance addresses major shortcomings in current CRT implants and could dramatically improve success rates for heart failure patients around the globe.”
The WiSE Technology is claimed to be the world's only wireless, endocardial (inside the heart) pacing system for stimulating the heart’s left ventricle.
Ohio State University Professor of Medicine and member of the study’s steering committee William Abraham said: “Patients who have failed conventional CRT continue to deteriorate from their heart failure and are repeatedly subjected to costly hospitalisations.
“We have actively sought new treatment alternatives for this large and growing patient population.
“WiSE is easily the most promising solution to this costly problem.
"Its tiny receiver makes endocardial, left ventricular pacing possible for the first time.
"There is nothing like it in cardiology.”
WiSE 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.
With the IDE approval, the company will initiate the 350 patient Stimulation of the Left Ventricle Endocardially–CRT study (SOLVE-CRT).
In order to participate in the trial, the patients must have either failed conventional CRT or they were previously untreatable with conventional CRT systems.
The SOLVE-CRT study will be a prospective, randomised controlled trial using generally-accepted measures of safety and efficacy as primary endpoints at six months. The company expects to start the clinical trial in mid next year.
Image: A diagram of the heart. Photo: courtesy of Business Wire.