TALENTIA SonR CRT-D 3811 - Biventricular pacemaker/defibrillator

Intended purpose

TALENTIA SonR CRT-D is an implantable cardiac resynchronization therapy defibrillators (CRT-D) used in combination with pacing and defibrillating leads. The device senses and records the electrical activity of the patient's heart using the electrodes of the implanted atrial and ventricular leads and analyzes the heart rhythm based on selectable detection parameters. The device provides simultaneous or sequential biventricular pacing using a LV electrode, and automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies through the delivery of shocks and electrical impulses. The device also responds to bradycardia by providing atrial and/or ventricular pacing. The device is indicated in: ― Patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible causes. ― Patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable. ― Patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or ventricular fibrillation induced at electrophysiological study. ― Patients with reduced LVEF due to prior myocardial infarction who are at least 40 days post-myocardial infarction and with symptomatic heart failure or LV dysfunction. ― Patients with non-ischemic dilated cardiomyopathy and reduced LVEF with symptomatic heart failure. ― Patients with non-sustained VT due to prior myocardial infarction, reduced LVEF and inducible ventricular fibrillation or sustained VT at electrophysiological study. Biventricular pacing therapy is indicated in patients with symptomatic heart failure despite optimal pharmacological therapy, with reduced LVEF and wide QRS.

Functional description

It is a cardioverter defibrillator for the recognition and treatment of ventricular tachycardia and fibrillation with ventricular resynchronization in patients with spontaneous or inducible tachyarrhythmias. It features Bluetooth® Low Energy wireless technology which enables remote monitoring of patients who have the compatible MicroPort SMARTVIEW CONNECT Monitor and wireless interrogation and device programming by a compatible MicroPort SMARTTOUCH programmer.