Avstralija - angleščina - 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.

Avstralija - angleščina - 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.

Avstralija - angleščina - 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.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 47205 - cardiac pulse generator programmer - smarttouch programmer consists in a tablet and associated portable accessories dedicated to communicate with the imds via inductive telemetry or rf telemetry. the smarttouch programmer embeds software modules dedicated to the communication with the different families of implants (symphony, reply, paradym, paradym rf, platinium and brady wireless) or to the management of these modules (manager). the smarttouch programmer is a microprocessor-based tablet used to program pacemakers and defibrillators. additionally, it provides measurement, ecg display and report printing functions. it is intended to perform the following tasks: - interrogate microport?s pacemakers and icds., - retrieve clinical and technical information collected in the device between two consecutive interrogations, - test the imd performances in order to (re)program device parameters, - upgrade the device software when needed. - generate patient files for storage and potential later review purposes

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 47805 - implantable cardiac monitor patient programmer - the smart spot is a radio frequency wireless monitor that collects clinical information and device parameters. the data is retrieved by the portable external monitor from an implanted cardiac device and routed through the cellular network, converted to a format that can be reported to the physician. the device includes smart spot, user manual, silicon sleeve, power supply and power adaptor the smart spot is indicated for the remote follow up of patients who are implanted with a microport implanted cardiac devices.

Avstralija - angleščina - 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

Avstralija - angleščina - 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.

Avstralija - angleščina - 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.

Avstralija - angleščina - 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

Avstralija - angleščina - 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