Device Dossier
Rivacor 7 HF-T - Biventricular pacemaker/defibrillator
Device Dossier for Rivacor 7 HF-T - Biventricular pacemaker/defibrillator (Biventricular pacemaker/defibrillator, Class III, sponsor Biotronik). ARTG…
- GMDN category: Biventricular pacemaker/defibrillator
Intended purpose
Rivacor 7 HF-T belongs to a family of implantable cardioverter-defibrillators (ICDs). The primary objective of the therapy is to prevent sudden cardiac death. Furthermore, the device is capable of treating bradycardia arrhythmias and cardiac resynchronization therapy with multisite ventricular pacing. The implantation of an ICD is a symptomatic therapy with the following objectives: •Termination of spontaneous ventricular fibrillation (VF) through shock delivery •Termination of spontaneous ventricular tachycardia (VT) through antitachycardia pacing (ATP); in case of ineffective ATP or hemodynamically not tolerated VTs, with shock delivery •Cardiac resynchronization through multisite ventricular pacing •Compensation of bradycardia through AV sequential pacing. HF-T devices with DX functionality are only indicated for patients not requiring atrial pacing. Triple-chamber ICDs are indicated for patients with the following risks: •Sudden cardiac death caused by ventricular arrhythmias •Congestive heart failure with ventricular asynchrony
Functional description
A triple chamber, rate adaptive ICD with Home Monitoring functions, max. shock energy 40J and DF4/IS-1 connector. Biocompatible titanium housing is hermetically sealed and serves as a potential antipole during shock delivery or in the case of unipolar lead configuration. The ellipsoid shape facilitates implantation in the pectoral muscle area. The connections for bipolar pacing, sensing, unipolar connections and shock delivery are found in the device header. MR conditional.