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

microport crm pty ltd - 31704 - pacemaker system analyser, magnetic - the magnet, a reusable non-implantable accessory of microport crm implantable pacemakers and defibrillators, is intended to switch the implantable device to the preprogrammed magnet mode when positioned on the skin over the device.

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

microport crm pty ltd - 61680 - implantable cardiac device management application software - the smartview connect application is part of the smartview remote monitoring system (rms), which is composed of the software itself installed on a off-the-shelf smartphone-like device and a back-office data management system controlled by microport crm. the purpose of the system is to remotely monitor microport crm implanted bluetooth?-enabled pacemakers in patients? homes. the smartview connect app allows the remote monitoring of patients implanted with a microport crm bluetooth? low energy-enabled pacemaker to treat symptomatic bradycardia. it is thus indicated in patients requiring atrial or ventricular pacing, or synchronous atrioventricular pacing.

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

microport crm pty ltd - 35223 - lead, pacemaker, implantable, endocardial - the sonrtip lead is an atrial endocardial lead equipped with a cardiac contractility sensor designed to be used with all microport implantable cardioverter defibrillators equipped with the sonr? function. inserted into the tip of the lead, the sensor is contained in a hermetically sealed cylindrical titanium capsule. its microaccelerometer measures heart muscle acceleration, while its electronic circuit transmits the signals to the compatible device. the lead is 1.5t and 3t mri conditional. sonrtip leads are right atrial endocardial steroid-eluting pacing leads intended for the

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - an implantable cardioverter defibrillator equipped with an accelerometer to allow adaptation of pacing to suit the patient?s activity. the device can be programmed and interrogated with a compatible microport dedicated programmer, using a compatible microport programming head for bi-directional telemetry. it can be equipped with the rf wireless technology which enables remote monitoring. connector: atrium is-1 bipolar; r ventricle df4; l ventricle is4. the device is 1.5t and 3t mr conditional. gali sonr crt-d and gali crt-d are implantable cardiac resynchronization therapy defibrillators (crt-d) used in combination with pacing and defibrillating leads. the devices sense and record the electrical activity of the patient's heart using the electrodes of the implanted atrial and ventricular leads and analyze the heart rhythm based on selectable detection parameters. the devices provide simultaneous or sequential biventricular pacing using a lv electrode, and automatically detect ventricular tachyarrhythmias (vt/vf) and provide treatment with defibrillation, cardioversion, and antitachycardia pacing therapies through the delivery of shocks and electrical impulses. the devices also respond to bradycardia by providing atrial and/or ventricular pacing. indications for use: - patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained vt after evaluation to define the cause of the event and to exclude any completely reversible causes. - patients with structural heart disease and spontaneous sustained vt, whether hemodynamically stable or unstable. - patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained vt or ventricular fibrillation induced at electrophysiological study. - patients with reduced lvef due to prior myocardial infarction who are at least 40 days post-myocardial infarction and with symptomatic heart failure or lv dysfunction. - patients with non-ischemic dilated cardiomyopathy and reduced lvef with symptomatic heart failure. - patients with non-sustained vt due to prior myocardial infarction, reduced lvef and inducible ventricular fibrillation or sustained vt at electrophysiological study. biventricular pacing therapy is indicated in patients with symptomatic heart failure despite optimal pharmacological therapy, with reduced lvef and wide qrs

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - an implantable cardioverter defibrillator equipped with an accelerometer to allow adaptation of pacing to suit the patient?s activity. the device can be programmed and interrogated with a compatible microport programmer, using a compatible microport programming head for bi-directional telemetry. it can be equipped with the rf wireless technology which enables remote monitoring. connector: atrium sonr; r ventricle df4; l ventricle is4. the device is 1.5t and 3t mr conditional. gali sonr crt-d and gali crt-d are implantable cardiac resynchronization therapy defibrillators (crt-d) used in combination with pacing and defibrillating leads. the devices sense and record the electrical activity of the patient's heart using the electrodes of the implanted atrial and ventricular leads and analyze the heart rhythm based on selectable detection parameters. the devices provide simultaneous or sequential biventricular pacing using a lv electrode, and automatically detect ventricular tachyarrhythmias (vt/vf) and provide treatment with defibrillation, cardioversion, and antitachycardia pacing therapies through the delivery of shocks and electrical impulses. the devices also respond to bradycardia by providing atrial and/or ventricular pacing. indications for use: - patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained vt after evaluation to define the cause of the event and to exclude any completely reversible causes. - patients with structural heart disease and spontaneous sustained vt, whether hemodynamically stable or unstable. - patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained vt or ventricular fibrillation induced at electrophysiological study. - patients with reduced lvef due to prior myocardial infarction who are at least 40 days post-myocardial infarction and with symptomatic heart failure or lv dysfunction. - patients with non-ischemic dilated cardiomyopathy and reduced lvef with symptomatic heart failure. - patients with non-sustained vt due to prior myocardial infarction, reduced lvef and inducible ventricular fibrillation or sustained vt at electrophysiological study. biventricular pacing therapy is indicated in patients with symptomatic heart failure despite optimal pharmacological therapy, with reduced lvef and wide qrs

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - an implantable cardioverter defibrillator equipped with an accelerometer to allow adaptation of pacing to suit the patient?s activity. the device can be programmed and interrogated with a compatible microport dedicated programmer, using a compatible microport dedicated programming head for bi-directional telemetry. it can also be equipped with the rf wireless technology which enables remote monitoring. connector: atrium is-1 bipolar; r ventricle is-1 bipolar, 2 df-1; l ventricle is-1 bipolar. gali sonr crt-d and gali crt-d are implantable cardiac resynchronization therapy defibrillators (crt-d) used in combination with pacing and defibrillating leads. the devices sense and record the electrical activity of the patient's heart using the electrodes of the implanted atrial and ventricular leads and analyze the heart rhythm based on selectable detection parameters. the devices provide simultaneous or sequential biventricular pacing using a lv electrode, and automatically detect ventricular tachyarrhythmias (vt/vf) and provide treatment with defibrillation, cardioversion, and antitachycardia pacing therapies through the delivery of shocks and electrical impulses. the devices also respond to bradycardia by providing atrial and/or ventricular pacing. indications for use: - patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained vt after evaluation to define the cause of the event and to exclude any completely reversible causes. - patients with structural heart disease and spontaneous sustained vt, whether hemodynamically stable or unstable. - patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained vt or ventricular fibrillation induced at electrophysiological study. - patients with reduced lvef due to prior myocardial infarction who are at least 40 days post-myocardial infarction and with symptomatic heart failure or lv dysfunction. - patients with non-ischemic dilated cardiomyopathy and reduced lvef with symptomatic heart failure. - patients with non-sustained vt due to prior myocardial infarction, reduced lvef and inducible ventricular fibrillation or sustained vt at electrophysiological study. biventricular pacing therapy is indicated in patients with symptomatic heart failure despite optimal pharmacological therapy, with reduced lvef and wide qrs.

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - an implantable cardioverter defibrillator equipped with an accelerometer to allow adaptation of pacing to suit the patient?s activity. the device can be programmed and interrogated with a compatible microport dedicated programmer, using a compatible microport dedicated programming head for bi-directional telemetry. it can also be equipped with the rf wireless technology which enables remote monitoring. connector: atrium is-1 bipolar; r ventricle df4; l ventricle is-1 bipolar. gali sonr crt-d and gali crt-d are implantable cardiac resynchronization therapy defibrillators (crt-d) used in combination with pacing and defibrillating leads. the devices sense and record the electrical activity of the patient's heart using the electrodes of the implanted atrial and ventricular leads and analyze the heart rhythm based on selectable detection parameters. the devices provide simultaneous or sequential biventricular pacing using a lv electrode, and automatically detect ventricular tachyarrhythmias (vt/vf) and provide treatment with defibrillation, cardioversion, and antitachycardia pacing therapies through the delivery of shocks and electrical impulses. the devices also respond to bradycardia by providing atrial and/or ventricular pacing. indications for use: - patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained vt after evaluation to define the cause of the event and to exclude any completely reversible causes. - patients with structural heart disease and spontaneous sustained vt, whether hemodynamically stable or unstable. - patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained vt or ventricular fibrillation induced at electrophysiological study. - patients with reduced lvef due to prior myocardial infarction who are at least 40 days post-myocardial infarction and with symptomatic heart failure or lv dysfunction. - patients with non-ischemic dilated cardiomyopathy and reduced lvef with symptomatic heart failure. - patients with non-sustained vt due to prior myocardial infarction, reduced lvef and inducible ventricular fibrillation or sustained vt at electrophysiological study. biventricular pacing therapy is indicated in patients with symptomatic heart failure despite optimal pharmacological therapy, with reduced lvef and wide qrs.

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - an implantable cardioverter defibrillator equipped with an accelerometer to allow adaptation of pacing to suit the patient?s activity. the device can be programmed and interrogated with a compatible microport dedicated programmer, using a compatible microport dedicated programming head for bi-directional telemetry. it can also be equipped with the rf wireless technology which enables remote monitoring. connector: atrium sonr; r ventricle is-1 bipolar; l ventricle is-1 bipolar. gali sonr crt-d and gali crt-d are implantable cardiac resynchronization therapy defibrillators (crt-d) used in combination with pacing and defibrillating leads. the devices sense and record the electrical activity of the patient's heart using the electrodes of the implanted atrial and ventricular leads and analyze the heart rhythm based on selectable detection parameters. the devices provide simultaneous or sequential biventricular pacing using a lv electrode, and automatically detect ventricular tachyarrhythmias (vt/vf) and provide treatment with defibrillation, cardioversion, and antitachycardia pacing therapies through the delivery of shocks and electrical impulses. the devices also respond to bradycardia by providing atrial and/or ventricular pacing. indications for use: - patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained vt after evaluation to define the cause of the event and to exclude any completely reversible causes. - patients with structural heart disease and spontaneous sustained vt, whether hemodynamically stable or unstable. - patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained vt or ventricular fibrillation induced at electrophysiological study. - patients with reduced lvef due to prior myocardial infarction who are at least 40 days post-myocardial infarction and with symptomatic heart failure or lv dysfunction. - patients with non-ischemic dilated cardiomyopathy and reduced lvef with symptomatic heart failure. - patients with non-sustained vt due to prior myocardial infarction, reduced lvef and inducible ventricular fibrillation or sustained vt at electrophysiological study. biventricular pacing therapy is indicated in patients with symptomatic heart failure despite optimal pharmacological therapy, with reduced lvef and wide qrs.

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - an implantable cardioverter defibrillator equipped with an accelerometer to allow adaptation of pacing to suit the patient?s activity. the device can be programmed and interrogated with a compatible microport dedicated programmer, using a compatible microport dedicated programming head for bi-directional telemetry. it can also be equipped with the rf wireless technology which enables remote monitoring. connector: atrium sonr; r ventricle df4; l ventricle is-1 bipolar. gali sonr crt-d and gali crt-d are implantable cardiac resynchronization therapy defibrillators (crt-d) used in combination with pacing and defibrillating leads. the devices sense and record the electrical activity of the patient's heart using the electrodes of the implanted atrial and ventricular leads and analyze the heart rhythm based on selectable detection parameters. the devices provide simultaneous or sequential biventricular pacing using a lv electrode, and automatically detect ventricular tachyarrhythmias (vt/vf) and provide treatment with defibrillation, cardioversion, and antitachycardia pacing therapies through the delivery of shocks and electrical impulses. the devices also respond to bradycardia by providing atrial and/or ventricular pacing. indications for use: - patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained vt after evaluation to define the cause of the event and to exclude any completely reversible causes. - patients with structural heart disease and spontaneous sustained vt, whether hemodynamically stable or unstable. - patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained vt or ventricular fibrillation induced at electrophysiological study. - patients with reduced lvef due to prior myocardial infarction who are at least 40 days post-myocardial infarction and with symptomatic heart failure or lv dysfunction. - patients with non-ischemic dilated cardiomyopathy and reduced lvef with symptomatic heart failure. - patients with non-sustained vt due to prior myocardial infarction, reduced lvef and inducible ventricular fibrillation or sustained vt at electrophysiological study. biventricular pacing therapy is indicated in patients with symptomatic heart failure despite optimal pharmacological therapy, with reduced lvef and wide qrs

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

microport crm pty ltd - 37265 - defibrillator, implantable, automatic, dual-chamber - ulys dr is an implantable dual-chamber cardioverter defibrillator. it is equipped with an accelerometer to allow adaptation of pacing to suit the patient?s activity. it can be programmed and interrogated with a compatible microport dedicated programmer, using a compatible microport dedicated programming head for bi-directional telemetry. it is also equipped with the rf wireless technology which enables remote monitoring. connector: atrium is-1 bipolar; ventricle is-1 bipolar, 2 df-1. ulys dr is a dual chamber implantable cardioverter defibrillators (icd) used in combination with pacing and defibrillating lead(s). the devices sense and record the electrical activity of the patient's heart using the electrodes of the implanted atrial (for dr models only) and right ventricular leads and analyze the heart rhythm based on selectable detection parameters. the devices automatically detect ventricular tachyarrhythmias (vt/vf) and provide treatment with defibrillation, cardioversion, and antitachycardia pacing therapies through the delivery of shocks and electrical impulses. the devices also respond to bradycardia by providing atrial and/or ventricular pacing. ulys dr is indicated in: - patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained vt after evaluation to define the cause of the event and to exclude any completely reversible causes. - patients with structural heart disease and spontaneous sustained vt, whether hemodynamically stable or unstable. - patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained vt or ventricular fibrillation induced at electrophysiological study. - patients with reduced lvef due to prior myocardial infarction who are at least 40 days post-myocardial infarction and with symptomatic heart failure or lv dysfunction. - patients with non-ischemic dilated cardiomyopathy and reduced lvef with symptomatic heart failure. - patients with non-sustained vt due to prior myocardial infarction, reduced lvef and inducible ventricular fibrillation or sustained vt at electrophysiological study.