Device Dossier
VISIONIST CRT-P Model U225 - Biventricular pacemaker
Device Dossier for VISIONIST CRT-P Model U225 - Biventricular pacemaker (Biventricular pacemaker, Class III, sponsor Boston Scientific). ARTG record,…
- GMDN category: Biventricular pacemaker
Intended purpose
Boston Scientic cardiac resynchronization therapy pacemakers (CRT-Ps) are indicated for patients who have symptomatic congestive heart failure including left ventricular dysfunction and wide QRS; and/or one or more of the following conditions: • Symptomatic paroxysmal or permanent second- or third-degree AV block • Symptomatic bilateral bundle branch block • Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [SA] block) • Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias • Neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes Atrial tracking modes are also indicated for patients who may benet from maintenance of AV synchrony. Dual-chamber modes are specically indicated for treatment of the following: • Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block • VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm • Low cardiac output or congestive heart failure secondary to bradycardia Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with increases in minute ventilation and/or physical activity.
Functional description
This pulse generator provides a variety of therapies, including Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation and Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias. Device includes ZIP telemetry. Connector type RA: IS-1, RV: IS-1, LV: IS-1. Case is hermetically sealed titanium. Supplied with a torque wrench.