Bjrck M, Earnshaw JJ, Acosta S, et al. Gianmarco de Donato, MD Miami Cardiac and Vascular Institute FDA Clears Penumbra's Lightning 12 Aspiration Catheter for Pulmonary For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Created with Sketch. 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). Lightning is paired with CAT8 or CAT12. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use The Indigo Aspiration System with Lightning 12 removes these difficult-to-access, life-threatening clots, potentially reducing the need for thrombolytics and their associated ICU stays. INDIGO Aspiration System Indication for Use Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Copyright 2022 Penumbra, Inc. All rights reserved. Lightning 12 combines the Indigo System CAT12 aspiration catheter with lightning intelligent aspiration, enabling physicians to focus on optimising thrombus removal using the system's unique clot detection mechanism. The Indigo System with Lightning Intelligent Aspiration and Separators is indicated for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous . Disclosures: None. 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. However, these hybrid procedures include the invasiveness of open surgery and carry the risk of incomplete thrombus removal or vessel damage.1, Consequently, many new endovascular devices have been proposed to increase treatment success, decrease complications, and rapidly improve perfusion. Return all damaged devices and packaging to the manufacturer/distributor. Now, the goal with thrombus removal in PE is to safely and effectively remove thrombus and potentially reduce treatment time. 2021 Nov 1;48(5):e217571. Aspiration may also be performed in conjunction with an Indigo System Separator (Penumbra, Inc.) to allow for constant clearing of thrombus from the lumen of the catheter.
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