INTENSIA Models: VR 124, DR 154, CRT-D 174 || Product Usage: || OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). OVATIO CRT 6750, PARADYM CRT-D 8750, PARADYM SonR 8770, PARADYM RF CRT-D 9750, PARADYM RF SonR 9770 and INTENSIA CRT-D 174 are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The devices are also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer.
Model Number: Model number OVATIO family is constituted by the following models: OVATIO VR 6250 OVATIO DR 6550 OVATIO CRT 6750 PARADYM ICD/CRT-D family is constituted by the following models: • PARADYM VR 8250 • PARADYM DR 8550 • PARADYM CRT-D 8750 • PARADYM SonR 8770 • PARADYM SonR TriV 8970 PARADYM 2 ICD/CRT-D family is constituted by the following models: • PARADYM 2 VR 8252 • PARADYM 2 DR 8552 • PARADYM 2 CRT-D 8752 • PARADYM 2 SonR CRT-D 8772 PARADYM RF ICD family is constituted by the following models: • PARADYM RF VR 9250 • PARADYM RF DR 9550 • PARADYM RF CRT-D 9750 • PARADYM RF SonR 9770 INTENSIA ICD family is constituted by the following models: • INTENSIA VR 124 • INTENSIA DR 154 • INTENSIA CRT-D 174 • INTENSIA SonR CRT-D 184 Serial Number: All distributed OVATIO / PARADYM/ PARADYM 2 /PARADYM RF/ INTENSIA devices, of which approximately 67,183 have been distributed as of December 31st, 2016.