Device Dossier
Rivacor 7 VR-T DX - Defibrillator, implantable, automatic
Device Dossier for Rivacor 7 VR-T DX - Defibrillator, implantable, automatic (Defibrillator, implantable, automatic, Class III, sponsor Biotronik). ARTG…
- GMDN category: Defibrillator, implantable, automatic
Intended purpose
Rivacor 7 VR-T DX belongs to a family of implantable cardioverter-defibrillators (ICD). The primary objective of the therapy is to prevent sudden cardiac death. Furthermore, the device is capable of treating bradycardia arrhythmias with 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 •Compensation of bradycardia through AV sequential pacing. VR-T DX devices are only indicated for patients not requiring atrial pacing. Single-chamber are indicated for patients with the following risk: •Sudden cardiac death caused by ventricular arrhythmias
Functional description
A single 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. Ellipsoid shape facilitates implantation in the pectoral muscle area. The connections for bipolar pacing, sensing and shock delivery are in the header. DX functionality also senses in the right atrium. MR conditional.