Prior to use, please consult device labeling and instructions for use. Warnings/Precautions Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. Possible complications include, but are not limited to, the following: These pages are not intended for patients or for members of the general public. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Precautions The device is intended for single use only. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . In patients with submassive pulmonary embolism with compromised right ventricular function and elevated biomarkers, the Indigo System is an excellent frontline tool offering a safe and effective1 treatment option. The removal of fibrous, adherent or calcified material (e.g. 0 cm from the distal tip. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. The catheters (CAT3, CAT RX*, CAT5, CAT6, CAT8, CATD) vary in diameters from 3.4 to 8 F and lengths of 50 to 150 cm to . left-arrow Available in a selection of sizes, the CAT family can provide access to distal peripheral . Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. The penumbra cat8 indigo system (cat8) was kinked approximately 4. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. PENUMBRA ENGINE Intended Use The CAT family of catheters is the foundation of Penumbra's Indigo System. The atraumatic, low-profile design of CAT RX allowed for ease of deliverability through the freshly placed stent into the PDA when the patient was in critical condition. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. If the cause cannot be determined, withdraw the device or system as a unit. Mechanical clot engagement with proprietary Separator technology, Tip directionality for circumferential aspiration, The Indigo System is an integrated system for use only with other components of the Indigo System including the CAT family of catheters, Separators, Dynamic Aspiration Tubing, Lightning, Penumbra ENGINE, and Penumbra ENGINE Canister, Lightning Computer-Aided Aspiration comes packaged with CAT7 or CAT12, Live feedback during the procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. 3. The newest indication for the Indigo System is the treatment of pulmonary embolism; this indication comes on the heels of the promising results of the EXTRACT-PE trial. The Indigo System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. The Indigo System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. Vascular Thrombectomy. The INDIGO Aspiration System is intended to serve as a conduit to assist in thrombus removal and restoration of blood flow in the peripheral vasculature and for the treatment of pulmonary embolism. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Lightning comes packaged with the Indigo CAT7 or CAT12. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. 2017;377:2240-2252. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Do not resterilize or reuse. function gtag(){dataLayer.push(arguments);} After one pass with CAT RX, the initial occlusion was removed. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). Maintain a constant infusion of appropriate flush solution. The Indigo Separator is advanced and retracted through the corresponding size Indigo catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip. gtag('js', new Date()); Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Flow through left circumflex artery post-CAT RX. If the cause cannot be determined, withdraw the device or system as a unit. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. 8: Add BMK6F95M-NE . As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 (Penumbra, Inc.) are indicated for the removal of fresh soft emboli and thrombi from vessels in the coronary and peripheral vasculature. Additional Details. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. The means of mains disconnect is to remove the power cord. Penumbras IndigoAspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. chronic clot, atherosclerotic plaque) The cerebral vasculature Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. The Indigo Separator is advanced and retracted through the corresponding size Indigo catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip. The pain became more intense and constant, so he presented to the ED. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). Penumbras Indigo Aspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism and/or certain central circulatory system conditions such as pulmonary emboli. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. Potential Adverse Events Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arrhythmia/fibrillation; arteriovenous fistula; death; device malfunction; distal embolization; emergent surgery; false aneurysm formation; hematoma, hemorrhage, or blood loss at access site; hematoma, hemorrhage, or blood loss; hypotension; inability to completely remove thrombus or control blood flow; infection; ischemia; kidney damage from contrast media; myocardial infarction; neurological deficits including stroke; respiratory failure; thromboembolic events; vascular complications (including vessel spasm, thrombosis, intimal disruption, dissection, or perforation). allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; respiratory failure; peripheral thromboembolic events. No conversations found. Director, Structural Heart Preprocedure TIMI 0 flow was seen in 76.3% of patients; TIMI 3 flow immediately post-CAT RX was demonstrated in 93.2% of patients. Learn more about Lightning. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. This website is intended for US audience only. This site is protected by reCAPTCHA and the Google, Mechanical clot engagement with proprietary Separator technology, Tip directionality for circumferential aspiration, The Indigo System is an integrated system for use only with other components of the Indigo System including the CAT family of catheters, Separators, Dynamic Aspiration Tubing, Lightning, Penumbra ENGINE, and Penumbra ENGINE Canister, Lightning Intelligent Aspiration comes packaged with CAT7, CAT8 or CAT12, Live feedback during the procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. Otherwise, this could result in degradation of the performance of this equipment. Contraindications There are no known contraindications. Copyright 2022 Penumbra, Inc. All rights reserved. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Throughout each case, Lightning provides procedural feedback via audio visual cues. This content is not intended to offer professional medical advice. These pages are not intended for patients or for members of the general public. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30 cm) to any part of LIGHTNING Aspiration Tubing.

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