FDA designated EBR Systems' wireless cardiac pacing system as a breakthrough device for the treatment of heart failure, the company said Tuesday.
The device, called the WiSE CRT System, features two components that collectively sense the pacing pulse emitted by an existing, conventional pacemaker and use that signal to pace the left ventricle.
EBR said this process synchronizes the left and right ventricles, enabling patients who are poorly served by conventional cardiac resynchronization therapy (CRT) to effectively pump blood.
Physicians typically try to achieve biventricular pacing in heart failure patients by implanting a coronary sinus lead. That lead connects an existing pacemaker that is pacing the right ventricle to the other side of the heart, resulting in cardiac resynchronization.
However, implanting the lead is a complex procedure that can fail or lead to complications. Studies suggest up to 40% of patients do not respond to conventional CRT. A further 10% of patients cannot undergo the procedure due to anatomical constraints. Alternative approaches, such as transseptal endocardial left ventricular pacing, are available but all of the options have limitations.
EBR said the WiSE CRT System can address these limitations. The device has two components. The first component is a pulse generator implanted underneath the skin in the vicinity of the heart. This component picks up the pacing pulse from a conventional pacemaker and sends out a signal to the second element.
The second component is a receiver electrode implanted in the left ventricle. When the electrode receives the ultrasound signal sent out by the pulse generator, it delivers electrical stimulation to the left ventricle. The chain of events, starting with the pacing of the right ventricle and ending with the delivery of electrical stimulation, is intended to resynchronize the two parts of the heart.
EBR has generated clinical data to validate the concept. One trial enrolled 35 heart failure patients who had tried conventional CRT without success or were ineligible for the procedure. The WiSE CRT System was successfully implanted in all but one of the patients.
After one month, 33 of the patients had achieved biventricular pacing, resulting in the trial meeting its primary performance endpoint. After six months, the clinical composite scores of 28 patients had improved. However, three patients suffered serious events related to the procedure or device in the 24 hours after implantation. Eight patients suffered serious events over the following month.
EBR received a CE mark in 2015 and is now working to get the device onto the U.S. market. A global, 350-patient clinical trial designed to generate data to support FDA approval is underway.
Under the terms of the breakthrough designation, EBR stands to receive additional support from FDA as it develops the device and potentially an expedited approval. EBR could also benefit from changes to the reimbursement of breakthrough devices. If EBR makes it that far, it will face competition from companies including Abbott and Medtronic.