Blood clots in the lungs can block the lungs from absorbing oxygen, causing strain on the heart and other organs. A wire test was conducted in the right leg to determine the composition of the clot. The Penumbra Indigo System Separator is intended for use with our Indigo System's CAT family of catheters to enable the removal of a wide range of thrombus. University of Siena 1Virani, S.S. et al. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. 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. Do not use in oxygen rich environment. Michael S. Rosenberg, MD, FSIR, FACR CAT12 is a large . 2014;59:729-36. Access was gained using an 8-F sheath in the left popliteal vein, which was then upsized to a 12-F sheath. The Indigo System Lightning 12 was launched in July and is available immediately for patients needing interventional treatment for PE. We opted for aspiration thrombectomy with the Indigo System Lightning 12 with the 100-cm HTORQ tip (Penumbra, Inc.). 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. Created with Sketch. The CAT8s large lumen can allow for efficient clot removal, which can be enhanced when paired with mechanical separation from the SEP8. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Miami Cancer Institute 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. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Vessel patency is assessed using the thrombolysis in myocardial infarction (TIMI) score classifications, both before and after the use of the device. CAT12 features a large 0.131-inch lumen and angled tip for additional circumferential sweep (Figure 2). Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. should be used no closer than 12 inches (30 cm) to any part of LIGHTNING Aspiration Tubing. Do not use open or damaged packages. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Mean PA pressure at the start of the case was 35 mm Hg. 2018;29:92-100. doi: 10.1016/j.jvir.2017.08.019. Do not use open or damaged packages. Henderson Hospital The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. It is low-profile and deliverable to all vascular territories in the pulmonary circulation. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Mean PA pressure postintervention was 21 mm Hg. 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. Interventional Radiology 4 min read. Use prior to the Use By date. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Potential adverse . Use prior to the Use By date. Do not resterilize or reuse. Using the Lightning 12 and SEP12 (Penumbra, Inc.), we removed a huge clot from the iliac vein with a retrograde approach to the thrombus. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Frank R. Arko III, MD Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. No modification of this equipment is allowed. Disclosures: None. Lightning 12. The Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. Lightning is paired with CAT8 or CAT12. Warnings/Precautions The canister is intended for single use only. Device Problem Adverse Event Without Identified Device or Use Problem (2993) The product was not returned for evaluation. INDIGO Aspiration System Indication for Use Created with Sketch. Disclosures: Consultant to Penumbra, Inc. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Only use replacement fuse with correct rating (see Table 1 for fuse rating). This website is intended for US audience only. The Indigo System with . July 14, 2020P enumbra, Inc. announced the United States commercial availability of the Indigo System Lightning 12, which is the company's next-generation aspiration system for peripheral thrombectomy.. 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. In such a case, the use of multiple catheters (CAT8 for popliteal, CAT6 for tibials, and CAT3 for plantars) was particularly helpful (Figure 2 and Figure 3). If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Precautions The device is intended for single use only. Otherwise, this could result in degradation of the performance of this equipment. The means of mains disconnect is to remove the power cord. Angiography after Indigo power aspiration and popliteal aneurysm repair with a stent graft (Viabahn, Gore & Associates) revealed a patency of the tibial (A) and plantar (B) vessels. Stainless steel hypotube; Large lumen size and circumferential sweep enables maximized thrombus engagement; Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Silver, DO, FACC, FSVM, RPVI; Catalin Toma, MD; Pavan Khanna, MD; Mitchell Weinberg, MD; and Andrew Galmer, DO. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Precautions The device is intended or single use only. Image showing the total thrombus removed. The Indigo Systems proprietary Separator technology, Separator 12 is also available with Lightning 12 and is designed to enable unobstructed aspiration for the duration of the procedure. 2019;140:e774-e801. Otherwise, this could result in degradation of the performance of this equipment. The 1:1 torqueability of the catheter was especially valuable for aspirating thrombus along the circumference of the larger-diameter iliac veins. Precautions The device is intended for single use only. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Created with Sketch. Copyright 2022 Penumbra, Inc. All rights reserved. The Indigo System has been designed to address the limitations of traditional treatment options. Eric Moldestad, MD The INDIGO SEPARATOR is not intended for use as a guidewire. Ballad Health System CVA Heart & Vascular Institute Thrombolysis is not a universal option for all patient groups, especially if the patient has an absolute or relative contraindication to a fibrinolytic agent. Intraoperative angiography can identify any arterial imperfection after surgical thromboembolectomy, which may be corrected simultaneously by endovascular techniques. The CAT familyof catheters is the foundation of Penumbras Indigo System. Do not block bottom air vents. Chief of Vascular Surgery Return all damaged devices and packaging to the manufacturer/distributor. (Photo: Business Wire). Lightning 12 and Lightning 8 expand the already broad offering of CAT8, CATD, CAT6, CAT5, and CAT3 and are paired with Penumbra ENGINE, the companys proprietary continuous, mechanical vacuum aspiration pump. 12 F Laser Cut Hypotube Catheter. Real-world use of the Indigo System Lightning 7 and Lightning 12 Intelligent Aspiration in arterial, pulmonary embolism, and venous cases. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 4. The Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. Contraindications Not for use in the coronaries or the neurovasculature. In PE cases, patients are often emergent and need interventions that provide immediate relief. 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.. Ask the Experts: How Do You Treat (and Avoid) Recurrent Varicose Veins? Professor, Cardiovascular Surgery Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 2023 Bryn Mawr Communications II, LLC. (EXTRACT-PE). Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with . Kingsport, Tennessee In addition, the RV/LV ratio decreased from 2.26 to 1.09, over a > 50% on-table decrease. Created with Sketch. NYU Langone Health J Vasc Surg. Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. Figure 1. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change. The Indigo CAT12 Aspiration Catheter is indicated for removal of fresh, soft emboli and thrombi from vessels of the peripheral venous systems. Figure 2. Total aspiration time was 34 minutes. Many of the first-generation mechanical endovascular devices for thrombus removal have failed to be adequately successful or have been associated with unacceptable complication rates. Department of Medicine, Surgery and Neuroscience Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. In the current treatment of PE, standard treatments such as anticoagulation, thrombolysis, and open embolectomy have limitations. Heart disease and stroke statistics2020 update: a report from the American Heart Association. 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.