Cobalt? XT HF Quad CRT-D MRI SureScan? DTPA2QQ - Biventricular pacemaker/defibrillator

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Medtronic Australasia Pty Ltd

Class:

AIMD

Manufactured by:

Medtronic Inc 710 Medtronic Parkway, Minneapolis, MN, 55432 United States Of America

Therapeutic area:

47270 - Biventricular pacemaker/defibrillator

Therapeutic indications:

The devices in this application are dual chamber, implantable cardioverter defibrillators with cardiac resynchronization therapy (CRT-D). These multiprogrammable cardiac devices monitor and regulate the patient?s heart rate by providing single or dual chamber, rate-responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies. The devices feature Bluetooth wireless technology. Lead Connector: IS4/DF4 Cobalt? XT HF Quad CRT-D MRI SureScan? device is indicated for use in patients who are at significant risk of developing atrial and/or life-threatening ventricular arrhythmias and who have heart failure with ventricular arrhythmias. Heart failure patients must have experienced one or more of the following conditions: ? Ventricular dyssynchrony ? Reduced ejection fraction, regardless of New York Heart Association (NYHA) class, who are indicated for ventricular pacing and have high degree AV block ? Reduced ejection fraction and all the following characteristics: ? Have received a conventional pacemaker or an ICD ? Have subsequently developed worsening heart failure despite optimal medical therapy ? Have a high proportion of RV pacing

Authorization status:

A

Authorization date:

2020-08-14