INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 Indication for Use 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. Otherwise, this could result in degradation of the performance of this equipment. 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 the PENUMBRA ENGINE. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Lightning 12 with Intelligent Aspiration is a giant leap forward for the field of thrombectomy, and we have been very impressed with the early results at Sanger.. Created with Sketch. Previous Article, Biotronik's Dynetic-35 Iliac Stent Launched in Europe. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. Warnings/Precautions The canister is intended for single use only. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. 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. Pulmonary embolism (PE) is a condition that occurs when blood clots, typically traveling from the veins in the legs, get caught in the arteries of the lungs. We opted for aspiration thrombectomy with the Indigo System Lightning 12 with the 100-cm HTORQ tip (Penumbra, Inc.). The means of mains disconnect is to remove the power cord. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. The Lightning 12 addition to the Indigo Aspiration System is a formative development in the thrombectomy space. Author S Jay Mathews 1 Affiliation 1 Bradenton Cardiology Center, Manatee . Venogram showing CAT12 in the CIV. To prevent fire or shock hazard, use a replacement power cord of equal rating. Sponsored by Penumbra, Inc. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Intelligent Aspiration. We performed a transjugular access with a 12-F introducer sheath. The new Indigo System is engineered to allow for thrombectomy while helping to prevent excessive blood loss during the procedure. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Mean PA pressure at the start of the case was 35 mm Hg. With Frank R. Arko III, MD; Patrick E. Muck, MD, RVT, FACS; Ripal T. Gandhi, MD, FSIR, FSVM; Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM; Michael S. Rosenberg, MD, FSIR, FACR; Eric Moldestad, MD; Gianmarco de Donato, MD; Thomas S. Maldonado, MD; and D. Chris Metzger, MD. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo System and Lightning 12 Intelligent Aspiration Tex Heart Inst J. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Do not re-infuse blood or fluid from the canister back into the patient. The continuously powered engine pump , which is activated by a single touch, achieves a negative suction pressure of 29 inHg, a nearly pure vacuum. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Patrick E. Muck, MD, RVT, FACS Earlier in November 2020, Penumbra announced the receipt of 510(k) FDA clearance for an expanded indication of the latest iteration of the Indigo Aspiration System, Lightning 12. Executive Medical Director of Interventional Radiology & Vascular Imaging Mentors and Protgs: Conversations on Career and Craft With Alda L. Tam, MD, MBA, FRCPC, FSIR, FACR, The Patient Voice in Chronic Venous Disease Treatment: What We Have and Whats Coming Next, With Kathleen Gibson, MD, FACS, FAVLS, DABVLM; Al Compaan; and Manj Gohel, MBChB, MD, FRCS, FEBVS. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Do not resterilize or reuse. The Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. With the severity of this patients symptoms, immediate relief was required to maintain limb viability and the different profiles of the Indigo catheters provided a complete portfolio for aspiration in the arterial vasculature, starting with the CAT8 in the SFA and BTK to using the CAT RX coaxially in the heavily diseased TPT. 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. Maintain a constant infusion of appropriate flush solution. . Disclosures: None. 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. Giri J, Sista A, Weinberg I, et al. In particular, the Indigo catheters vary from 3 to 8 Fenabling the operator to remove thrombus from small vessels such as the pedal arch but also from large vessels such as the aorta or iliac arteries, due to the circumferential aspiration from the tip shapes offered in CAT8. All Rights Reserved Privacy Policy, With Frank R. Arko III, MD; Patrick E. Muck, MD, RVT, FACS; Ripal T. Gandhi, MD, FSIR, FSVM; Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM; Michael S. Rosenberg, MD, FSIR, FACR; Eric Moldestad, MD; Gianmarco de Donato, MD; Thomas S. Maldonado, MD; D. Chris Metzger, MD, Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 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; arteriovenous fistula; cardiac injury; cardio-respiratory arrest; death; device malfunction; distal embolization; emboli; excessive blood loss; 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; hemoptysis; respiratory failure; thromboembolic events. Contraindications There are no known contraindications. Venogram showing thrombosis of the left FV and CFV. The Indigo System has been designed to address the limitations of traditional treatment options. doi: 10.1111/j.1525-139X.2012.01104.x. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism . Figure 1. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. A 47-year-old woman with no previous history of thromboembolism presented with sudden-onset PE. Manhattan Veterans Administration Hospital Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Disclosures: None. The INDIGO SEPARATOR is not intended for use as a guidewire. As PE treatment options continue to grow, the EXTRACT-PE results with the Indigo System serve as a promising data set in helping move the PE landscape forward. From syringe aspiration to sustained aspiration and now to intelligent aspiration, the aspiration thrombectomy field has grown leaps and bounds, now finding itself at a place where the Indigo System with the Lightning Intelligent Aspiration optimizes the thrombus removal procedure by differentiating between thrombus and blood. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Created with Sketch. This website is intended for US audience only. The Indigo Aspiration System, along with the Penumbra ENGINE and Indigo CAT8, provide a frontline treatment option for PE patients that can lower on-table PA pressures and reduce RV/LV ratios by 27.3%, per their investigational device exemption trial, EXTRACT-PE.1 The trial and our case experience at the University of Minnesota with CAT8 show that sustained aspiration with the Indigo System can provide safe mechanical relief in the treatment of PE. Saxon RR, Benenati JF, Teigen C, et al. 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. J Vasc Surg. 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. No modification of this equipment is allowed. With the maximized inner diameter of 0.082 and a 7 French outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. It will reduce the service life of the PENUMBRA ENGINE. 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. In addition to Lightning 12, the Indigo System also now includes Lightning 8 which combines the Indigo System CAT 8 Aspiration Catheter with Lightning Intelligent Aspiration for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. (Photo: Business Wire). Penumbra, Inc. Do not use in an oxygen rich environment. Figure 2. February 2022. 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 primary outcome is the rate of TIMI 2-3 revascularization after treatment using the Indigo System.
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