Device typeLeft-ventricular wireless pacing system sensor/transmitter: A hermetically-sealed device intended to be implanted beneath the skin of the chest in a surgically-created pocket to: 1) sense signals from a separate co-implanted pacemaker; and 2) generate and transmit synchronized ultrasound (US) pulses to a left-ventricular endocardial transducer/electrode (not included). The US pulses will be converted into electrical pacing impulses and synchronized with the co-implanted pacemaker to achieve cardiac resynchronization therapy (CRT). It consists of a small unit with sensing electrodes and an ultrasound generator/transmitter. Disposable devices dedicated to implantation may be included.
FDA categoryLeadless Cardiac Resynchronization Therapy (Crt)
Device ID00859244007005
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional