Claria MRI CRT-D SureScan Model DTMA2D1 - Biventricular pacemaker/defibrillator

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Medtronic Australasia Pty Ltd

Class:

Class III

Manufactured by:

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

Therapeutic area:

47270 - Biventricular pacemaker/defibrillator

Therapeutic indications:

The Medtronic Model DTMA2D1 Claria MRI dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac device that monitors and regulates 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. Medtronic Claria MRI Model DTMA2D1 cardiac resynchronization therapy implantable defibrillators (CRT-Ds) are indicated for use in patients who are at significant risk of developing life-threatening ventricular tachyarrhythmias and who have heart failure with ventricular arrhythmias. Heart failure patients must have experienced one or more of the following conditions: ? Ventricular dyssynchrony with prolonged QRS ? Reduced ejection fraction (EF), regardless of New York Heart Association (NYHA) class, if the patient is indicated for ventricular pacing and has high degree atrioventricular (AV) block ? Reduced EF with all of the following characteristics: ? The patient received a conventional pacemaker or an implantable cardioverter defibrillator (ICD). ? The patient subsequently developed worsening heart failure despite optimal medical therapy. ? The patient has a high proportion of right ventricular (RV) pacing.

Authorization status:

A

Authorization date:

2022-08-03