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

penumbra neuro australia pty ltd - 41978 - surgical irrigation/aspiration system - the reperfusion catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. for the aspiration source, the penumbra reperfusion catheter is used in conjunction with the aspiration pump, which is connected using the penumbra aspiration tubing and the penumbra pump/canister tubing. as part of the penumbra system, the reperfusion catheters are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral ? m1 and m2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. the penumbra sterile aspiration tubing is indicated to connect the penumbra reperfusion catheters to the penumbra pump max. patients who are ineligible for intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy are candidates for treatment.

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

penumbra neuro australia pty ltd - 58173 - embolectomy/thrombectomy suction catheter - the reperfusion catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. this device is a variable stiffness catheter with a proximal shaft made of stainless steel and nitinol wire. it is used with an aspiration pump and separator to aspirate and assist with thrombus removal from an occluded vessel. as part of the penumbra system, the reperfusion catheters are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral ? m1 and m2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. patients who are ineligible for intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy are candidates for treatment.

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

penumbra neuro australia pty ltd - 58173 - embolectomy/thrombectomy suction catheter - the reperfusion catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. this device is a variable stiffness catheter with a proximal shaft of stainless steel wire and a distal shaft coiled with nitinol wire. it is used with an aspiration pump and separator to aspirate and assist with thrombus removal from an occluded vessel. as part of the penumbra system, the reperfusion catheters are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral ? m1 and m2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. patients who are ineligible for intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy are candidates for treatment.

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

penumbra neuro australia pty ltd - 58173 - embolectomy/thrombectomy suction catheter - the reperfusion catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. it is a variable stiffness catheter with a diameter that is tapered along its length, a catheter shaft reinforced with a nitinol coil and a radiopaque markerband on the distal end. it is used with an aspiration pump and separator to assist with thrombus removal from an occluded vessel. as part of the penumbra system, the reperfusion catheters are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral ? m1 and m2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. patients who are ineligible for intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy are candidates for treatment.

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

penumbra neuro australia pty ltd - 10691 - intravascular microflow catheter - the penumbra delivery microcatheters are single lumen medical devices designed to aid a physician in accessing distal vasculature when using in conjunction with a guide catheter and a micro guidewire. penumbra delivery microcatheters are supplied with annealed stainless steel mandrels that can be used to shape the distal tip as desired. the penumbra delivery microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils to the peripheral and neuro vasculature.

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

penumbra neuro australia pty ltd - 10691 - intravascular microflow catheter - the penumbra delivery microcatheters are single lumen medical devices designed to aid a physician in accessing distal vasculature when using in conjunction with a guide catheter and a micro guidewire. penumbra delivery microcatheters are supplied with annealed stainless steel mandrels that can be used to shape the distal tip as desired. the penumbra delivery microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils to the peripheral and neuro vasculature.

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

penumbra neuro australia pty ltd - 35449 - prosthesis, internal, embolization, intravascular - the embolization coil functions to selectively embolize aneurysms or targeted segments of the vasculature by packing a sufficient quantity of soft platinum coils to achieve occlusion. the penumbra coil system is indicated for the endovascular embolization of: - intracranial aneurysms. - other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. - arterial and venous embolizations in the peripheral vasculature.

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

penumbra neuro australia pty ltd - 10714 - catheter, embolectomy - once the reperfusion catheter is in place it provides a conduit to remove the thrombus using the penumbra separator (a catheter designed to 'grab' the thrombus). th reperfusion catheter is also attached to the aspiration pump allowing a negative pressure to assist in the removal of the thrombus. the reperfusion catheter is intended to be used with the penumbra separator and the penumbra aspiration tubing to remove thrombus. the reperfusion catheter provides access to the occusion site and then provides a conduit to remove the thrombus. the device is intended for use in the revascularisation of patients with acute ischemic stroke secondary to intracranial large vessel occulusive disease, within 8 hours of onset. patients who are ineligible for intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy are candidates for treatment.

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

penumbra neuro australia pty ltd - 10714 - catheter, embolectomy - intended in the revascularisation of patients. the device is a 'catheter' designed to assist the removal of a thrombus from a vessel. it is passed through the pemumbra reperfusion catheter once in place and dislogdes the thrombus allowing the aspiration of the thrombus. the penumbra separator has a core stainless steel wire. the penumbra seperator is intended to be used with the penumbra reperfusion catheter and penumbra aspiration tubing to remove thrombus. the separator tip is designed to clear the thrombus from the lumen of the reperfusion catheter during aspiration. the device is intended for use in the revascularisation of patients with acute ischemic stroke secondary to intracranial large vessel occulusive disease, within 8 hours of onset. patients who are ineligible for intravenous tissue plasminogen activator (iv t-pa) or who fail iv t-pa therapy are candidates for treatment.

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

penumbra neuro australia pty ltd - 43980 - embolization implant kit - the smart coil functions to selectively embolize targeted segments of the vasculature by packing a sufficient quantity of bare-platinum coils to achieve occlusion in an identical fashion to the penumbra coil system and other bare-platinum embolization coils. the smart coil consists of three components: a coil implant, attached to a detachment pusher, and a detachment handle. penumbra smart coil system is indicated for the embolization of: ? intracranial aneurysms ? other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae ? arterial and venous embolizations in the peripheral vasculature