Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - 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: is-1/df-1 crome? hf 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

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - 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: is-1/df-1 cobalt? hf 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

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - 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? 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

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - 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

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - 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: is-1/df-1 cobalt? xt hf 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

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - 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 type: is4/df4 crome? hf quad crt-d mri surescan? 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

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - the medtronic model dtmb2d1 amplia 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 amplia mri model dtmb2d1 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - the medtronic model dtmb2d4 amplia 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 amplia mri model dtmb2d4 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - the medtronic model dtmb2qq amplia mri quad 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 amplia mri quad model dtmb2qq 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 47270 - biventricular pacemaker/defibrillator - 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.