Device typeLeft-ventricular wireless pacing system transducer/electrode: A device consisting of an endocardial electrode with an ultrasound transducer intended to be implanted within the left ventricle of the heart to receive ultrasound (US) pulses from a parent transmitter and convert these into electrical pacing impulses to pace the left ventricle for cardiac resynchronization therapy (CRT) with a separate co-implanted pacemaker. It consists of a small electrode with a transducer intended to be attached to the endocardium. It is intended as an alternative to left-ventricular pacing using a coronary venous pacing lead. Disposable devices dedicated to implantation (e.g., delivery catheter) may be included.
FDA categoryLeadless Cardiac Resynchronization Therapy (Crt)
Device ID00859244007067
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information