Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Next Article 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 . Ask the Experts: How Do You Treat (and Avoid) Recurrent Varicose Veins? Use prior to the Use By date. Miami Cancer Institute Do not resterilize or reuse. Powered by the Penumbra Engine, Lightning 7 and Lightning 12 combine the new Indigo system CAT7 and CAT12 aspiration catheters with Lightning intelligent aspiration, a computer-aided clot detection technology that can differentiate between clot and blood. PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW. We opted for aspiration thrombectomy with the Indigo System Lightning 12 with the 100-cm HTORQ tip (Penumbra, Inc.). Patrick E. Muck, MD, RVT, FACS Disclosures: None. The Indigo System Lightning 12 is the companys newest generation aspiration system for peripheral thrombectomy. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Sponsored by Penumbra, Inc. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Intelligent Aspiration. Professor, Cardiovascular Surgery Do not use kinked or damaged devices. Penumbra also announced appointments for two newly created positions: Corey L. Teigen, MD, as Chief Scientific Officer and James F. Benenati, MD, as Chief Medical Officer. Use only water-based solvents for cleaning. It is low-profile and deliverable to all vascular territories in the pulmonary circulation. INDIGO SEPARATOR 4 is intended to be used with INDIGO CAT RX Aspiration Catheter to clear the distal end of the catheter lumen should it be blocked with thrombus. 2020;59:173-218. doi: 10.1016/j.ejvs.2019.09.006. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. The audiovisual cues from Lightning and the thrombus detection algorithm enabled us to navigate the lobar branches of the PA. Lightnings audio cues, in the form of clicking, help with clot detection to optimize thrombus removal and focus on the screen rather than monitor flow through the tubing and canister. A 57-year-old man presented with acute-onset left calf pain for the past 10 days and had recently taken a 4-hour flight. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. At the 30-day follow-up, the patient no longer had residual shortness of breath or exertional dyspnea. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Contraindications There are no contraindications. 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. Program Director, Vascular Fellowship & Integrated Residency 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. Lightning 12 combines the 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. The latest addition to the catheter line, the CAT12, is Penumbras most torqueable and trackable catheter to date. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Image of thrombus aspirated using the Indigo CAT12 Aspiration Catheter. The Indigo System with . Do not use kinked or damaged devices. Preprocedural CT of the patients left pulmonary anatomy. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Penumbra, a global healthcare company, has secured the expanded US Food and Drug Administration 510 (k) approval for the new generation of its Indigo Aspiration System, Lightning 12. The means of mains disconnect is to remove the power cord. Chief, Vascular and Endovascular Surgery Figure 1. Executive Medical Director of Interventional Radiology & Vascular Imaging Disclosures: None. Lightning 12 and Separator 12 are designed for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. With Ramona Gupta, MD, FSIR; Suman M. Wasan, MD, MS, FSVM; and Avianne Bunnell, MD, RPVI, By Andres Schanzer, MD, FACS, and Stphan Haulon, MD, PhD, By Dominique Fabre, MD, PhD; Thomas J. Postiglione, MD; and Stphan Haulon, MD, PhD, Unmet Needs in Ascending and Arch Disease, With Tilo Klbel, MD, PhD, and Joseph Bavaria, MD, With Giovanni Pratesi, MD; Martina Bastianon, MD; Sara Di Gregorio, MD; Gaddiel Mozzetta, MD; and Kimberly Malka, MD, PhD, With Tim Resch, MD, PhD; Sara L. Zettervall, MD, MPH; and Carlos Timaran, MD. Low-dose tPA was dripped into the left and right lobes of the PA. In this case, the PE patient had an extremely high PA pressure of 35 mm Hg, which we were able to significantly reduce by 40%. After considering the acute onset of symptoms and the history of thrombosis, we decided to proceed with the Indigo System to treat the bilateral PE in one session. According to Penumbra, Lightning 12 combines the company's new Indigo System Cat 12 aspiration catheter with its Lightning Intelligent Aspiration to enable physicians to focus on optimizing thrombus removal using the systems clot detection mechanism. This website is intended for US audience only. It will reduce the service life of the PENUMBRA ENGINE. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. Factors that could cause actual results to differ from those projected include, but are not limited to: the impact of the COVID-19 pandemic on our business, results of operations and financial condition; failure to sustain or grow profitability or generate positive cash flows; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base, expand our user base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; permanent write-downs or write-offs of our inventory; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; and potential adverse regulatory actions. 2019;140:e774-e801. The Indigo System Catheter CAT8 was used across 22 sites in the United States in patients with submassive PE who did not receive thrombolytics (98.3%), with a right ventricular/left ventricular (RV/LV) ratio reduction of 27.3% at 48 hours. Thomas S. Maldonado, MD Figure 1. Percutaneous manual thromboaspiration was the first technique proposed, followed by a series of percutaneous mechanical thrombectomy devices based on a different mechanism of action (mechanical fragmentation, aspiration, rheolytic thrombectomy, and their combinations). The 1:1 torqueability of the catheter was especially valuable for aspirating thrombus along the circumference of the larger-diameter iliac veins. Carrera LA, Reddy R, Pamoukian VN, et al. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Created with Sketch. Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. doi: 10.1161/CIR.0000000000000707. Sustained aspiration from the Indigo System provides physicians with an alternative option for patients who are not ideal candidates for lytics or open embolectomy and provides a frontline therapy option that still preserves the use of any adjunctive therapy. Editors choiceEuropean Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the management of acute limb ischemia. The INDIGO SEPARATOR is not intended for use as a guidewire. 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). Precautions The device is intended for single use only. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. As part of the Indigo Aspiration System, Lightning 12 (Indigo System CAT 12 Aspiration Catheter with Lightning Intelligent Aspiration) and Separator 12 are now indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems as well as for the treatment of pulmonary embolism. The sustained aspiration from the Penumbra ENGINE provides constant uninterrupted full-vacuum aspiration throughout the procedure, addressing the constraints of syringe-based large-bore embolectomy, which include vacuum dropoff from the syringe filling with fluid. Do not use open or damaged packages. 2011;17:283-289. doi: 10.4261/1305-3825.DIR.3687-10.2, 3. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Resterilization and/or reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 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. Sanger Heart and Vascular Institute 4 min read. CAT 12 is a . Created with Sketch. Traditionally, tPA or open embolectomy were the primary treatment options for acute-to-chronic lesions. Lightning Intelligent Aspiration. 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. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Scan showing preoperative left venous thrombus. Immediately postprocedure, a decrease in PA pressure from 35 to 27 mm Hg was observed. . According to the American Heart Association, PE affects roughly 367,000 Americans per year.1. Penumbra, Inc. 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.
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