Device Dossier
Rivacor Sky VR-T DX - Defibrillator, implantable, automatic
Device Dossier for Rivacor Sky VR-T DX - Defibrillator, implantable, automatic (Defibrillator, implantable, automatic, Class III, sponsor Biotronik).…
- GMDN category: Defibrillator, implantable, automatic
Intended purpose
Rivacor Sky VR-T DX are implantable cardioverter-defibrillators (ICDs). An ICD is part of an implantable system comprising an implantable ICD along with pacing and ICD leads. The implantation of an ICD device is performed for the following objectives: • Monitoring the intrinsic heart rhythm and rate and detecting ventricular arrhythmias • Termination of ventricular tachycardia (VT) through antitachycardia pacing (ATP) • Termination of atrial tachycardia (AT/AF) through antitachycardia pacing (ATP) • Termination of ventricular fibrillation (VF) or ventricular tachycardia (VT) through shock delivery • Correction of bradycardia through atrial, ventricular or AV sequential pacing
Functional description
Single-chamber, rate-adaptive ICD with Home Monitoring functions. The device's ellipsoid shape facilitates implantation in the pectoral muscle area. The device detects tachyarrhythmias and restores physiological heart rate and rhythm. It also detects bradycardia and establishes physiological heart rate. The device provides sensing in the right atrium. MR conditional.