EBR Systems has developed a wireless cardiac pacing system, the Wireless Stimulation Endocardially (WiSE), for the treatment of heart failure.
WiSE improves the pumping ability of heart by synchronising the left and right ventricles to distribute blood to the lungs and body more effectively.
It uses a wireless electrode the size of a grain of rice, which is implanted in the left ventricle wall through a minimally invasive procedure, to regulate the accurate pacing from within the heart.
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.
The safety and efficacy of the WiSE CRT System’s pacing technology are being evaluated by the IDE-approved SOLVE CRT clinical trial, a prospective randomized, double-blinded pivotal study.
The study is enrolling 350 patients who have failed to or respond to or are otherwise unable to receive conventional CRT.
The U.S. Food and Drug Administration has granted Breakthrough Device Designation for the system.
Heart failure is a severe, progressive, debilitating disease condition where the heart fails to pump blood in required amounts for the body.
It is often caused due to the disruption of electrical signals within the heart, making its ventricles beat in an uncoordinated or unsynchronized pattern, resulting in an enlarged left ventricle and a weak heart.
Cardiac Resynchronization Therapy (CRT) or biventricular pacing is set to improve heart failure symptoms by electrically stimulating the heart, using wire leads to synchronize the left and the right ventricles, enabling two chambers to beat together.