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 programmer, using a compatible microport dedicated programming head for bi-directional telemetry. it is equipped with the rf wireless technology which enables remote monitoring. connector: atrium is-1 bipolar; ventricle df4.the device is 1.5t and 3t mr conditional. 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.

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

microport crm pty ltd - 35852 - defibrillator, implantable, automatic - ulys vr is an implantable single-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: is-1 bipolar, 2 df-1 ulys vr is a dual chamber implantable cardioverter defibrillator (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 vr 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.

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

microport crm pty ltd - 35852 - defibrillator, implantable, automatic - ulys vr is an implantable single-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 can also equipped with the rf wireless technology which enables remote monitoring. connector: ventricle: df4. the device is 1.5t and 3t mr conditional. ulys vr is a dual chamber implantable cardioverter defibrillator (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 vr 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.

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 the cardiac contractility sensor designed to be used with all microport icd's equipped with the sonr function. the sensor, inserted in the lead tip, is contained in a hermaetically sealed cylindrical titanium capsule. it has 2 main parts - a microaccelerometer measures heart muscle acceleration, while its electronic circuit transmits the signals to the compatible device, thus able to measure and record cardiac contractility. the sonrtip lead has cardiac pacing and sensing capabilities.the sonrtip lead is indicated for use with all microport cardiac resynchronisation therapy defibrillators equipped with the sonr function.

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

microport crm pty ltd - 46223 - pacing/defibrillation lead setscrew - sterile, single use screw driver to be used as a tool for attachment of permanent pacing leads to a permanent pacemaker.

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

microport crm pty ltd - 41651 - electrocardiograph, holter analyser, software - the device is a holter analysis software intended to be used to analyze, download and archive holter recordings.

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - platinium sonr crt-d 1844 implantable crt-d for the recognition and treatment of ventricular tachycardia and fibrillation with ventricular resynchronisation in patients with spontaneous or inducible tachyarrhythmias. it has an accelerometer for adaption of pacing to suit patients activity and rf wireless technology which enables remote monitoring of patients who have the smartview monitor & wireless interrogation & device programming by orchestra plus link platinium 4lv sonr crt-d 1844 is an implantable crt-d 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 electrop

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

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - platinium 4lv crt-d 1744 implantable crt-d for the recognition and treatment of ventricular tachycardia and fibrillation with ventricular resynchronisation in patients with spontaneous or inducible tachyarrhythmias. it has an accelerometer for adaption of pacing to suit patients activity and rf wireless technology which enables remote monitoring of patients who have the smartview monitor & wireless interrogation & device programming by orchestra plus link. platinium 4lv crt-d 1744 is an implantable crt-d 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 electrophysio

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

microport crm pty ltd - 47267 - single-chamber pacemaker, rate-responsive - oto sr pacemaker is single-chamber rate responsive pacemaker. it is equipped with a physiological sensor (minute ventilation) and an accelerometer to allow adaptation of pacing to suit the patient?s activity oto sr pacemaker is indicated for symptomatic paroxysmal or permanent second- or third-degree av block; symptomatic bilateral bundle branch block; symptomatic paroxysmal or transient sinus node dysfunctions with or without associated av conduction disorders; bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; vasovagal syndromes or hypersensitive carotid sinus syndromes. rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or activity. the device(s) are mr conditional in the 1.5t and 3t mr environment.

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

microport crm pty ltd - 47265 - dual-chamber pacemaker, rate-responsive - oto dr pacemaker is dddr-type dual-chamber rate responsive pacemaker. it is equipped with a physiological sensor (minute ventilation) and an accelerometer to allow adaptation of pacing to suit the patient?s activity oto dr pacemaker is indicated for symptomatic paroxysmal or permanent second- or third-degree av block; symptomatic bilateral bundle branch block, symptomatic paroxysmal or transient sinus node dysfunctions with or without associated av conduction disorders; bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias, vasovagal syndromes or hypersensitive carotid sinus syndromes. dual-chamber and atrial tracking modes in patients who may benefit from maintenance of av synchrony. dual-chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and av synchrony. the device(s) are mr conditional in the 1.5t and 3t mr environment.