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

abiomed australia pty ltd - 57791 - infusion pump cassette - intended to be used in the abiomed heart pump systems. it is inserted into the abiomed controller and connected to an iv fluid, typically a 5% dextrose with prescribed amounts of heparin to control the flow of fluids (purging) into the specific heart pumps.

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

abiomed australia pty ltd - 60723 - medical image management system - impella connect is intended to be used to enable remote viewing of the automated impella controller (aic) user interface by clinicians and by trained abiomed personnel who assist clinicians with troubleshooting automated impella controller alarms or other issues. impella connect transfers the video stream from the automated impella controller (via the vga output) to a cloud-based remote viewing portal. communication between the aic and impella connect is one-way (aic to impella connect), and the streamed video is limited to impella device operating parameters and alarm messages with no patient identifiable information. impella connect is powered directly by the automated impella controller

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

abiomed australia pty ltd - 56732 - intracardiac circulatory assist axial-pump catheter - the impellacp? pump supports the native heart by directly unloading the left ventricle. it is a circulatory support system for recovery and prophylactic or elective support during high risk percutaneous coronary intervention(pci), post pci, and for patients with reduced left ventricular function; it may also be used during coronary bypass surgery on the beating heart in patients with high risk of postoperative low output syndrome. impellacp? pump is a intracardiac pump for supporting the left ventricle;it is intended for clinical use in cardiology and in cardiac surgery for up to 5 days for supporting the native heart in patients with reduced left ventricular function

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

abiomed australia pty ltd - 56732 - intracardiac circulatory assist axial-pump catheter - the impella 5.0 is an intravascular microaxial blood pump that supports a patient's circulatory system. the impella 5.0 is inserted via femoral or axillary artery cut-down through the artery and into the left ventricle(lv). the impella 5.0 delivers blood from the inlet area,which sits inside the lv,through the cannula,to the outlet opening in the ascending aorta.the impella 5.0 pump reduces the workload of the heart as it continuously draws blood from the lv. the impella 5.0 heart pump is an intracardiac pump for supporting the left ventricle;it is intended for clinical use in cardiology and cardiac surgery for up to 10 days for supporting the heart in patients with reduced left ventricular function.

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

abiomed australia pty ltd - 16449 - clamp, cannula - intended to attach (during insertion) of the haemoshield graft to the introducer sheath for the introducer for impella pumps. the clamp is removed after insertion.

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

abiomed australia pty ltd - 47487 - medical device electrical cable, general purpose - a sterile cable intended to connect the impella heart pumps and the impella controller

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

abiomed australia pty ltd - 56732 - intracardiac circulatory assist axial-pump catheter - the impella rp heart pump is an intracardiac microaxial blood pump that supports a patient's pulmonary circulation. the impella rp is inserted percutaneously through the femoral vein and into the pulmonary artery. the impella rp delivers blood from inferior vena cava, through the cannula to the outlet opening in the pulmonary artery. the impella rp pump reduces the workload of the right heart as it continuously pumps blood from the inferior vena cava into the pulmonary artery the impella rp? system (percutaneous pump for right ventricular support) is intended for clinical use in cardiology, in cardiac surgery, and intensive care unit for up to 14 days for the following indications, as well as others: acute or transient reduction of the right ventricular function (eg, postcardiotomy low output syndrome) cardiogenic shock as a consequence of a posterior myocardial infarction with right ventricular heart failure right heart support during coronary beating heart bypass surgery, especially for patients with a reduced preoperative cardiac output or for patients having a high risk of developing a postoperative low output syndrome for other reasons right ventricular heart failure after implantation of a left ventricular assist device therapy unresponsive arrhythmias with a reduction of right ventricular output heart failure and/or cardiogenic shock as a consequence of refractory ventricular arrhythmias, as well as a consequence of sustained supraventricular arrhythmias, causing haemodynamic compromise.

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

abiomed australia pty ltd - 46852 - vascular occluder, single-use - intended to be placed around the shaft of the catheter to help control bleeding during and after insertion of the impella catheter

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

abiomed australia pty ltd - 56732 - intracardiac circulatory assist axial-pump catheter - the impella? catheter is an intravascular microaxial blood pump that supports a patient?s circulatory system. it is inserted percutaneously through the femoral artery and into the left ventricle.when properly positioned, the device delivers blood from the inlet area, which sits inside the left ventricle, through the cannula, to the outlet opening in the ascending aorta. correct positioning and functioning of the device can be monitored on the display screen of the automated impella? controller. ?the impella? (intracardiac pump for supporting the left ventricle) is intended for clinical use in cardiology and in cardiac surgery for up to 5 days for the following indications, as well as others: the impella? is a circulatory support system for patients with reduced left ventricular function, eg, postcardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction, or for myocardial protection after acute myocardial infarction. the impella? may also be used as a cardiovascular support system during coronary bypass surgery on the beating heart, particularly in patients with limited preoperative ejection fraction with a high risk of postoperative low output syndrome. support during high-risk percutaneous coronary intervention (pci) post-pci?

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

abiomed australia pty ltd - 56732 - intracardiac circulatory assist axial-pump catheter - the impellacp? pump supports the native heart by directly unloading the left ventricle. it is a circulatory support system for recovery and prophylactic or elective support during high risk percutaneous coronary intervention(pci), post pci, and for patients with reduced left ventricular function; it may also be used during coronary bypass surgery on the beating heart in patients with high risk of postoperative low output syndrome impellacp? with smartassist pump is a intracardiac pump for supporting the left ventricle; it is intended for clinical use in cardiology and in cardiac surgery for up to 5 days for supporting the native heart in patients with reduced left ventricular function`