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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. July 14, 2020Penumbra, Inc. announced the United States commercial availability of the Indigo System Lightning 12, which is the companys next-generation aspiration system for peripheral thrombectomy. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Stay informed on the week's top stories including literature summaries, device approvals, guideline changes, and more. Created with Sketch. The SEP12 was introduced to help clear the lumen of the catheter due to the heavy thrombus burden. This new thromboaspiration technology allows for clot removal and potential reduction in right heart and PA pressure. 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. Venogram showing stents in the left CIV and EIV. Perspectives on PE Care Using Penumbra's Indigo System With Lightning The patients left leg was cool to the touch with signs of paresthesia but with motor function still intact. Lightning 12 Intelligent Aspiration. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. The 1:1 torqueability of the catheter was especially valuable for aspirating thrombus along the circumference of the larger-diameter iliac veins. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Warnings/Precautions The canister is intended for single use only. Otherwise, this could result in degradation of the performance of this equipment. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Do not reuse. If repositioning of the INDIGO Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard catheter and guidewire techniques. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Use only water-based solvents for cleaning. Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the PENUMBRA ENGINE as they can interfere with and result in degradation of the performance of the equipment. LIGHTNING Aspiration Tubing Indication for Use Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Previous Article, Reversing the Death Spiral: FlowTriever Thrombectomy for High-Risk PE, With James Horowitz, MD, FACC; Mitchell J. Created with Sketch. 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. More recently, a number of other endovascular mechanical thrombectomy devices have been introduced as treatment options; however, many physicians still rely on adjunctive tPA, either to lace the thrombus at time of procedure or postoperatively via an in-dwelling lytic catheter. CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to . Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. J Vasc Interv Radiol. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Mean PA pressure at the start of the case was 35 mm Hg. Executive Medical Director of Interventional Radiology & Vascular Imaging 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 Aspiration System Lightning 12 granted FDA approval. Michael S. Rosenberg, MD, FSIR, FACR Precautions The device is intended for single use only. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on February 26, 2020, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 filed with the SEC on May 7, 2020, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 filed with the SEC on August 3, 2020, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 filed with the SEC on November 2, 2020. There was poor distal runoff after wire crossing, indicating acute thrombus (, The Indigo System Catheter CAT8 was used in the superficial femoral artery (SFA) with several passes until flow was restored and the patient could move and feel his leg again (. Poor flow through the left TPT. IVUS image showing a widely patent lumen after thrombectomy and stenting. The clot detection algorithm paired with the audiovisual cues lets the physician know when the catheter is in thrombus versus when it is in blood. 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. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Kingsport, Tennessee Figure 3. Although motor function was still intact, there was decreased sensation and delayed capillary refill in the left foot and calf. 2014;59:729-36. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Lightning 12 combines the Indigo System CAT12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the systems unique clot detection mechanism. Penumbra, Inc. Do not use open or damaged packages. The device is intended for single use only. Penumbra's Newest Generation of Indigo Aspiration System Receives FDA Scans revealed a left lower extremity venous thrombus extending from the calf to the common iliac vein (CIV) (Figure 1). Figure 2. The INDIAN registry is a prospective, multicenter registry designed to investigate, in a controlled setting, the safety and initial efficacy of the Indigo System in the treatment of acute peripheral arterial thromboembolism. 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. Lightning enables clot detection so the physician knows when . Figure 3. Silver, DO, FACC, FSVM, RPVI; Catalin Toma, MD; Pavan Khanna, MD; Mitchell Weinberg, MD; and Andrew Galmer, DO. Penumbra Indigo System | Vascular Thrombectomy Scan showing preoperative left venous thrombus. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Penumbra Announces the European Launch of the Indigo System With A venogram was performed via left popliteal vein access, which demonstrated thrombosis of the left femoral vein (FV) and common femoral vein (CFV) (Figure 1) and the previously stented left common iliac vein (CIV) and external iliac vein (EIV) (Figure 2). In the current treatment of PE, standard treatments such as anticoagulation, thrombolysis, and open embolectomy have limitations. Advancement of the CAT8 and CAT6 through the popliteal and tibial arteries (A, B). Venogram showing thrombosis of the left FV and CFV. With Lightning 8, we were able to clear the loft lobar branch and detect that we had established substantial inflow and outflow so we could move to the next affected lobe. Penumbra has changed the landscape of healthcare by providing truly innovative solutions for a wide realm of medical challenges. 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. When 4 solid illuminated bars on the . CT revealed bilateral ALI (Figure 1). Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. We gained access through the right CFV using a 14-F sheath. Created with Sketch. 1Virani, S.S. et al. Presented at Vascular InterVentional Advances (VIVA) 2019; November 6, 2019; Las Vegas, Nevada. Editors choiceEuropean Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the management of acute limb ischemia. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. At discharge, there have been no adverse device events, and clinical success at 1 month (defined as the absence of death and limb loss) is 98.6%.4. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. STRIDE is currently ongoing. right-arrow Of note, the patient was not a good candidate for thrombolysis due to retroperitoneal hemorrhage from lymph node biopsy several days earlier. Do not re-infuse blood or fluid from the canister back into the patient. 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. 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. (EXTRACT-PE). Miami Cardiac and Vascular Institute Manhattan Veterans Administration Hospital Frank R. Arko III, MD 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 . 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, Vascular and Endovascular Surgery Copyright 2022 Penumbra, Inc. All rights reserved. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump.