The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum (-29 inHg or 98.2 kPa) to our catheters, enabling thrombus removal in vessels of various sizes. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Figure 2. Department of Medicine, Surgery and Neuroscience 1. The system is indicated for the removal of fresh, soft emboli and thrombi . Lightning 12. Advancement of the CAT8 and CAT6 through the popliteal and tibial arteries (A, B). Do not use open or damaged packages. The PRISM trial, a retrospective case analysis assessing the rate of TIMI 2-3 flow after the use of Indigo and specifically the XTRACT technique, showed an 87.2% rate of revascularization post-Indigo and subsequent treatment of underlying stenosis in the same setting.1 The newly completed study studying the same primary outcome as PRISM, the INDIAN registry, showed an even higher rate of revascularization, 88.7%.2 Sustained aspiration for ALI could potentially increase the revascularization rate by serving as an effective single-session frontline option. Kingsport, Tennessee Image showing the total thrombus removed. Otherwise, this could result in degradation of the performance of this equipment. 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. As presented on November 21, 2019, at VEITH 2019 by Dr. Gianmarco de Donato, University of Siena, Italy. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. We opted for aspiration thrombectomy with the Indigo System Lightning 12 with the 100-cm HTORQ tip (Penumbra, Inc.). Thomas S. Maldonado, MD Giri J, Sista A, Weinberg I, et al. Lightning Intelligent Aspiration allows physicians to optimize the thrombus removal needed to complete venous thrombus procedures that would otherwise be more complicated. Do not use in oxygen rich environment. Created with Sketch. IVUS image showing a widely patent lumen after thrombectomy and stenting. Use prior to the Use By date. Placing guidewire too distal in the pulmonary vasculature or excessive manipulation of aspiration/ guiding catheter in the smaller, peripheral, and segmental pulmonary artery branches can result in vessel perforation. Do not resterilize or reuse. Intravascular ultrasound (IVUS) revealed May-Thurner syndrome, which was treated with stenting in the CIV and EIV; 100% of the clot was resolved (, The newly available Indigo CAT12 Aspiration Catheter (Penumbra, Inc.) was utilized to perform mechanical thrombectomy of the FV, CFV, and EIV and CIV without the use of thrombolytics (, Significant thrombus was aspirated from the Indigo CAT12 Aspiration Catheter (, May-Thurner narrowing of the left CIV was noted and treated with a Vici stent (Boston Scientific Corporation), with IVUS before treatment (, IVUS after thrombectomy and stenting showed a widely patent lumen (. Michael S. Rosenberg, MD, FSIR, FACR Precautions The device is intended for single use only. 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. Lightning 12 combines the Indigo System CAT12 Aspiration Catheter with . To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Penumbra, Inc. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change. I feel privileged to join Penumbras unparalleled group of talented engineers and leaders, and I look forward to contributing my scientific knowledge to help solve challenging medical problems., Dr. Benenati commented, Im excited to join Penumbra at this very important time for the company, where its poised for growth, as it moves into the next generation of intelligent clot removal and expand into rehabilitation with the recent launch of the Real system. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. The goal of this study is to create a prospective multicenter study that provides safety and performance data on the Indigo System as a frontline percutaneous aspiration thrombectomy approach for ALI patients for whom immediate treatment and revascularization can maintain limb viability. 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. The INDIGO SEPARATOR is not intended for use as a guidewire. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Silver, DO, FACC, FSVM, RPVI; Catalin Toma, MD; Pavan Khanna, MD; Mitchell Weinberg, MD; and Andrew Galmer, DO. Director, Venous Thromboembolic Center and Aortic Center Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements. Penumbra's Indigo Aspiration System Lightning 12 received FDA clearance for the treatment of pulmonary embolism. Return all damaged devices and packaging to the manufacturer/ distributor. The means of mains disconnect is to remove the power cord. The EXTRACT-PE trial demonstrated that the Indigo System can provide immediate mechanical relief using sustained aspiration. The on-table PA pressures were statistically reduced, and the median device time was 37 minutes. Penumbra, Inc. It will reduce the service life of the PENUMBRA ENGINE. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Dr. Benenati will join Penumbra on September 1, 2020, and will contribute to clinical and medical affairs strategies and advise upon global commercialization and market development activities. 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. Immediately after, Lightning with the Indigo System Catheter CAT8 was used to aspirate thrombus in the left PA (, Due to increased amounts of thrombus in the right lobe, the SEP8 was introduced to clear the lumen of the catheter (. 2014;59:729-36. 1. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. To ensure the most secure and best overall experience on our website, we recommend the latest versions of, https://www.penumbrainc.com/indigo-lightning/, http://www.penumbrainc.com/healthcare-professionals. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. doi: 10.14503/THIJ-21-7571. 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. NYU Langone Health Disclosures: None. Immediately postprocedure, a decrease in PA pressure from 35 to 27 mm Hg was observed. Patrick E. Muck, MD, RVT, FACS Contraindications Not for use in the coronaries or the neurovasculature. According to the American Heart Association, PE affects roughly 367,000 Americans per year.1. Embolization: Expanding Evidence and Awareness. 2018;29:92-100. doi: 10.1016/j.jvir.2017.08.019. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Do not resterilize or reuse. No modification of this equipment is allowed. Such results give more evidence for a shift of treatment recommendation toward endovascular options in the patients with ALI, as already suggested by the recent European Society of Cardiology/European Society for Vascular Surgery guidelines. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. Learn more about Lightning. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. (Photo: Business Wire). This new thromboaspiration technology allows for clot removal and potential reduction in right heart and PA pressure. Localization of the thrombus was quite variable in our cohort of patients, although in the majority of cases (67%), patients presented with thrombus in the popliteal or BTK vessels. Disclosures: None. Return all damaged devices and packaging to the manufacturer/distributor. CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to . 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. Angiography showed the presence of a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism tibial (A) and plantar arteries (B). Do not reuse. With a device time of only 5 minutes and no use of tPA, the patients symptoms were promptly relieved with no recurring episodes to date. The patients left leg was cool to the touch with signs of paresthesia but with motor function still intact. Lightning 12 combines the Indigo System CAT 12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. Designed for single session arterial thrombus removal, New angled tip shape for maximized clot extraction, Dual pressure sensors for real-time flow monitoring, Large lumen size and circumferential sweep enables maximized thrombus engagement, Multi-pitch hypotube for 1:1 torque transfer and advanced deliverability, Indicated for the treatment of pulmonary embolism. 2. The reasons have been mainly related to the limited trackability, the risk of vessel injury, and/or the incidence of incomplete revascularization, and the risk of bleeding and hemolysis.2,3. To prevent fire or shock hazard, use a replacement power cord of equal rating. The latest addition to the catheter line, the CAT12, is Penumbras most torqueable and trackable catheter to date. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Department of Diagnostic, Molecular, and Interventional Radiology Circulation. The Indigo System has demonstrated high rates of revascularization with consistent success. When 4 solid illuminated bars on the . 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. Created with Sketch. Precautions The device is intended for single use only. STRIDE is currently ongoing. Created with Sketch. Lightning has also demonstrated an 18:1 potential fluid loss savings during bench top testing when used versus the Dynamic Aspiration Tubing. INDIGO Aspiration System Indication for Use 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 unique computer-aided clot detection technology that can differentiate between clot and blood, designed to reduce blood loss and the need for clot-dissolving drugs, which . Chief of Vascular Surgery Contraindications There are no contraindications. The catheter is robust and trackable, and the large lumen allows for thrombectomy either with a guidewire in place or without a guidewire. doi: 10.1111/j.1525-139X.2012.01104.x. Minneapolis, Minnesota Editors choiceEuropean Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the management of acute limb ischemia. Do not use in oxygen rich environment. Now, the goal with thrombus removal in PE is to safely and effectively remove thrombus and potentially reduce treatment time.

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