Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 58865 - vascular introducer kit - safesheath ii is a haemostatic peel-away introducer system for vascular access. it has a low insertion/withdrawal force lubricated valve, ergonomically-designed, easy-splitting hub, extruded score line sheath, infusion side port and snap-fit dilator. the adelante safesheath ii hemostatic introducer system for vascular access is intended for the introduction of various types of pacing leads and catheters. it is a sterile, single use device.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 58865 - vascular introducer kit - the adelante peel away introducer system consists of an introducer sheath and a dilator. some models include accessories: syringe, needle and guidewire (with j shaped distal tip with straightener). the sheath tube has a hydrophobic coating and a tapered tip. the sheath material is manufactured with radiopaque material which allows the visualization under fluoroscopy. the adelante peel away introducer system is intended for the introduction of pacing leads or catheters into the body. it is sterile and single use.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 37265 - defibrillator, implantable, automatic, dual-chamber - an implantable cardioverter defibrillator 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 features bluetooth? low energy (ble) wireless technology which enables remote monitoring, and wireless interrogation and device programming by a compatible microport smarttouch programmer. talentia dr 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. the device 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.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 35852 - defibrillator, implantable, automatic - an implantable cardioverter defibrillator 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 features bluetooth? low energy (ble) wireless technology which enables remote monitoring and wireless interrogation and device programming by a compatible microport smarttouch programmer. talentia vr is a single 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. the device 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.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - it is a cardioverter defibrillator for the recognition and treatment of ventricular tachycardia and fibrillation with ventricular resynchronization in patients with spontaneous or inducible tachyarrhythmias. it device features bluetooth? low energy wireless technology which enables remote monitoring of patients who have compatible microport smartview connect monitor and wireless interrogation and device programming by a compatible microport smarttouch programmer. it is 1.5t and 3t mr conditional talentia 4lv sonr crt-d is an 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. the device 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. biventricular pacing therapy is indicated in patients with symptomatic heart failure despite optimal pharmacological therapy, with reduced lvef and wide qrs.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 37265 - defibrillator, implantable, automatic, dual-chamber - the device is an implantable dual-chamber cardioverter defibrillator. it is equipped with an accelerometer to allow adaptation of pacing to suit the patient's activity. this device features bluetooth? low energy (ble) wireless technology which enables remote monitoring of patients who have compatible microport smartview connect monitor installed at home, and wireless interrogation and device programming by a compatible microport smarttouch programmer. the device is 1.5t and 3t mr conditional. talentia dr is a dual chambers 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. the device 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.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - it is a cardioverter defibrillator for the recognition and treatment of ventricular tachycardia and fibrillation with ventricular resynchronization in patients with spontaneous or inducible tachyarrhythmias. it features bluetooth? low energy wireless technology which enables remote monitoring of patients who have the compatible microport smartview connect monitor and wireless interrogation and device programming by a compatible microport smarttouch programmer. talentia sonr crt-d is an implantable cardiac resynchronization therapy defibrillators (crt-d) used in combination with pacing and defibrillating leads. the device senses and records the electrical activity of the patient's heart using the electrodes of the implanted atrial and ventricular leads and analyzes the heart rhythm based on selectable detection parameters. the device provides simultaneous or sequential biventricular pacing using a lv electrode, and automatically detects ventricular tachyarrhythmias (vt/vf) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies through the delivery of shocks and electrical impulses. the device also responds to bradycardia by providing atrial and/or ventricular pacing. the device 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. biventricular pacing therapy is indicated in patients with symptomatic heart failure despite optimal pharmacological therapy, with reduced lvef and wide qrs.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 47270 - biventricular pacemaker/defibrillator - it is a cardioverter defibrillator for the recognition and treatment of ventricular tachycardia and fibrillation with ventricular resynchronization in patients with spontaneous or inducible tachyarrhythmias. it features bluetooth? low energy wireless technology which enables remote monitoring of patients who have compatible microport smartview connect monitor and wireless interrogation and device programming by a compatible microport smarttouch programmer. talentia sonr crt-d is an 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. the device 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. biventricular pacing therapy is indicated in patients with symptomatic heart failure despite optimal pharmacological therapy, with reduced lvef and wide qrs.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

microport crm pty ltd - 35852 - defibrillator, implantable, automatic - the device is an implantable single-chamber cardioverter defibrillator. it is equipped with an accelerometer to allow adaptation of pacing to suit the patient's activity. this device features bluetooth? low energy (ble) wireless technology which enables remote monitoring of patients who have compatible microport smartview connect monitor installed at home, and wireless interrogation and device programming by a compatible microport smarttouch programmer. the device is 1.5t and 3t mr conditional. talentia vr is a single 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. the device 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.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

microport orthopedics pty ltd - 33175 - metallic femoral head prosthesis - the subject device is a series of cocr femoral head featuring standard polish surface roughness. the implants are designed to be used in combination with any microport orthopedics acetabular cup system. a total hip system component used to replace the femoral head. intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis; 2) femoral neck fracture; 3) revision procedures where other treatments or devices have failed.