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

medtronic australasia pty ltd - 47533 - implantable ventricular circulatory assist system - the heartware ventricular assist system utilizes a centrifugal blood pump which is implanted in the pericardial space with left ventricular apex to ascending aortic cannulation for left ventricular support. the inflow conduit is integrated with the pump and a outflow graft with a strain relief attached to the pump. a percutaneous driveline connects the pump to an external controller. the controller regulates pump function and monitors the system. the heartware hvad? system is intended for use in patients at risk of death from refractory end-stage heart failure. the heartware? system is designed for in-hospital and out-of hospital settings, including transportation via fixed wing aircraft or helicopter.

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

medtronic australasia pty ltd - 32585 - catheter, neurological, ventricular - the innervision ventricular catheter is designed to be used with a compatible medtronic neurosurgery endoscope. direct vision facilitates placement of the catheter tip at a specific intraventricular location. the catheter is designed to be used as the proximal component of a csf-flow control shunt for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity. a flexible tube that is surgically inserted through the skull and brain to access the cerebrospinal fluid-filled cavities of the brain (ventricles). this device is single-use.

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

medtronic australasia pty ltd - 32585 - catheter, neurological, ventricular - the opus catheter is a ventricular catheter fabricated from silicone elastomer tubing, impregnated with barium sulfate to provide radiopacity. a right angle clip is packaged to angulate the catheter at the burr-hole without kinking. each opus ventricular catheter is packaged with an opus stylet designed to facilitate introduction of the catheter. the opus stylet has a hollow shaft, permitting a free flow of csf during catheter placement. a flexible tube that is surgically inserted through the skull and brain to access the cerebrospinal fluid-filled cavities of the brain (ventricles). this device is single-use.

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

integra neurosciences pty ltd - 32585 - catheter, neurological, ventricular - once a burr hole has been drilled into the scalp and the dura punctured, the catheter is advanced into the ventricles until csf flows. after securing the catheter in place it is attached to a separately provided external drainage set to permit collection of csf. intended for use to drain from ventricles for external cerebrospinal drainage, sampling and collection

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

abbott medical australia pty ltd - 35852 - defibrillator, implantable, automatic - the unify assura cd3361-40c is a cardiac resynchronisation therapy device with rf telemetry and it monitors and regulates the patient?s heart rate by providing ventricular tachyarrhythmia therapy and single site pacing. it features an is-1/df-1 device header and parylene coating. the unify assura cd3361-40c is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. cardiac resynchronization therapy devices (crt-ds) are also intended to resynchronize the right and left ventricles in patients with congestive heart failure. also at/af detection algorithm is indicated for detecting atrial tachyarrhythmias which have been found to be associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior history of af.

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

abbott medical australia pty ltd - 35852 - defibrillator, implantable, automatic - the unify assura cd3361-40qc is a cardiac resynchronisation therapy device with rf telemetry and it monitors and regulates the patient?s heart rate by providing ventricular tachyarrhythmia therapy and single site pacing. it features a df4 device header and parylene coating. the unify assura cd3361-40qc is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. cardiac resynchronization therapy devices (crt-ds) are also intended to resynchronize the right and left ventricles in patients with congestive heart failure. also at/af detection algorithm is indicated for detecting atrial tachyarrhythmias which have been found to be associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior history of af.

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

abbott medical australia pty ltd - 61747 - implantable ventricular circulatory assist system outflow cannula, animal-derived - the heartmate 3 sealed outflow graft is a component within the heartmate 3 left ventricular assist system (hm3 lvas) and consists of a sealed woven polyester graft and the hardware necessary to attach the graft to the implanted pump cover. the distal end of the graft is sutured to the ascending aorta. the sealed outflow graft, a component within the heartmate 3 left ventricular assist system (hm3 lvas), is a gelatin-sealed polyester tube that connects the implanted pump to the aorta. the hm3 lvas is intended to provide haemodynamic support in patients with advanced, refractory left ventricular heart failure.

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

medtronic australasia pty ltd - 47263 - biventricular pacemaker - the medtronic serena quad crt-p mri surescan model w4tr05 dual chamber implantable pulse generator with cardiac resynchronization therapy (crt-p) is a multi-programmable cardiac device that monitors and regulates the patient?s heart rate by providing single or dual chamber rate-responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. this device features bluetooth wireless technology. the serena quad crt-p mri surescan system is indicated for any of the following types of heart failure patients: ? patients with ventricular dyssynchrony ? patients with reduced ejection fraction (ef), regardless of new york heart association (nyha) class, who are indicated for ventricular pacing, and have high degree av block ? patients with reduced ef and all of 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 - 47263 - biventricular pacemaker - the medtronic serena crt-p mri surescan model w1tr05 dual chamber implantable pulse generator with cardiac resynchronization therapy (crt-p) is a multi-programmable cardiac device that monitors and regulates the patient?s heart rate by providing single or dual chamber rate-responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. this device features bluetooth wireless technology. the serena crt-p mri surescan system is indicated for any of the following types of heart failure patients: ? patients with ventricular dyssynchrony ? patients with reduced ejection fraction (ef), regardless of new york heart association (nyha) class, who are indicated for ventricular pacing, and have high degree av block ? patients with reduced ef and all of 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 - 47263 - biventricular pacemaker - the medtronic percepta quad crt-p mri surescan model w4tr04 dual chamber implantable pulse generator with cardiac resynchronization therapy (crt-p) is a multi-programmable cardiac device that monitors and regulates the patient?s heart rate by providing single or dual chamber rate-responsive bradycardia pacing,sequential biventricular pacing, and atrial tachyarrhythmia therapies. this device features bluetooth wireless technology. the percepta quad crt-p mri surescan system is indicated for any of the following types of heart failure patients: ? patients with ventricular dyssynchrony ? patients with reduced ejection fraction (ef), regardless of new york heart association (nyha) class, who are indicated for ventricular pacing, and have high degree av block ? patients with reduced ef and all of 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