Maintain a constant infusion of appropriate flush solution. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. PENUMBRA ENGINE Indication for Use Intraoperative angiography can identify any arterial imperfection after surgical thromboembolectomy, which may be corrected simultaneously by endovascular techniques. LIGHTNING Aspiration Tubing Indication for Use MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW 510-995-2461 Investor Relations: Disclosures: None. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Sista A. 2020;141(9):e139e596. In the current treatment of PE, standard treatments such as anticoagulation, thrombolysis, and open embolectomy have limitations. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Low-dose tPA was dripped into the left and right lobes of the PA. Do not use in oxygen rich environment. right-arrow Do not block bottom air vents. 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. Use prior to the Use By date. Penumbra continues to strive to bring innovative therapies to the medical community, and this is another important milestone that will help advance pulmonary embolism intervention, said Adam Elsesser, president and chief executive officer, Penumbra. Venogram showing thrombosis of the left FV and CFV. The decision was made to proceed with mechanical thrombectomy. 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. doi: 10.1111/j.1525-139X.2012.01104.x. 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. From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event. The means of mains disconnect is to remove the power cord. Created with Sketch. Figure 1. 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 Indigo System aspiration catheter is available in a range of lengths and diameters that, when connected to the proprietary Penumbra Aspiration Pump, may help atraumatically remove the thrombus under continuous aspiration. Angiography showed the presence of a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism tibial (A) and plantar arteries (B). Penumbra continues to lead the field of clot management by bringing highly innovative technology to address the challenges that we as physicians face while caring for our patients, commented Frank Arko, MD, in the company's announcement. (EXTRACT-PE). Precautions The device is intended or single use only. 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. 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. Figure 2. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. 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. Figure 2. Lightning has also demonstrated an 18:1 potential fluid loss savings during bench top testing when used versus the Dynamic Aspiration Tubing. If the cause cannot be determined, withdraw the device or system as a unit. The results may not be predictive of all patients. MHealth Fairview System Medical Director for Interventional Radiology Operations
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. Editors choiceEuropean Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the management of acute limb ischemia. Heart disease and stroke statistics2020 update: a report from the American Heart Association. Although motor function was still intact, there was decreased sensation and delayed capillary refill in the left foot and calf. It is low-profile and deliverable to all vascular territories in the pulmonary circulation. No modification of this equipment is allowed. 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. Diagn Interv Radiol. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Created with Sketch. 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. 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. Figure 5. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Kingsport, Tennessee
Prior to use, please refer to the . The CAT familyof catheters is the foundation of Penumbras Indigo System. If the cause cannot be determined, withdraw the device or system as a unit. February 2022. Good Samaritan Hospital
Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to . This combination of intelligent aspiration and large-lumen catheter engineering makes Lightning 12 Penumbras most advanced clot removal technology for the treatment of pulmonary embolism. 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. 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. 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. All Rights Reserved Privacy Policy. 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. Semin Dial. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo Venogram showing CAT12 in the CIV. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Additional information about Penumbras products can be located on Penumbras website at http://www.penumbrainc.com/healthcare-professionals. Dr. Arko is chief, Division of Vascular and Endovascular Surgery, Sanger Heart and Vascular Institute in Charlotte, North Carolina. 12 F Laser Cut Hypotube Catheter. The major adverse event rate in EXTRACT-PE was 1.7%, and patients had a median intensive care unit stay of < 1 day. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Professor, Cardiovascular Surgery
betsy@merrymancommunications.com 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. The patient also had a history of bilateral PE dating back to October 2017, at which point rivaroxaban was prescribed. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change. Do not use kinked or damaged devices. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Do not reuse. No modification of this equipment is allowed. . 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. University of Minnesota
Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Do not use kinked or damaged devices. 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. Gianmarco de Donato, MD
It is a welcome addition to our existing endovascular technologies for the treatment of acute PE. D. Chris Metzger, MD
In PE cases, patients are often emergent and need interventions that provide immediate relief. New York, New York
Do not use kinked or damaged devices. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Created with Sketch. Do not resterilize or reuse. Figure 2. Except for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Contraindications There are no known contraindications. Miami Cancer Institute
J Vasc Interv Radiol. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the U.S., most of Europe, Canada and Australia, and through distributors in select international markets. 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. 1. Associate Professor of Radiology and Surgery
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. 310-560-8176. Otherwise, this could result in degradation of the performance of this equipment. Sponsored by Penumbra, Inc. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Intelligent Aspiration. Total aspiration time was 34 minutes. Manhattan Veterans Administration Hospital
Do not use in an oxygen rich environment. IVUS image showing a widely patent lumen after thrombectomy and stenting. Notably, Lightning 7 is designed . Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. To gain access into the lobar branches, a 5-F, 125-cm vertebral catheter over a 0.035-inch stiff, angled Glidewire (Terumo Interventional Systems) was used. Do not use open or damaged packages. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Do not use open or damaged packages. Circulation. ALAMEDA, Calif.--(BUSINESS WIRE)--Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the latest iteration of the Indigo Aspiration System, Lightning 12. Postoperative angiogram showing 100% resolution of thrombus. 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). Penumbra Launches Indigo System Lightning 12 and Appoints Medical and 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. Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. 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 (. Fluoroscopy showed additional thrombus in the tibioperoneal trunk (TPT) (, Final fluoroscopy of the left leg showed restored distal runoff (. 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. With contributions from Edoardo Pasqui, MD; Carlo Setacci, MD; and Giancarlo Palasciano, MD, Surgical management of lower extremity acute limb ischemia (ALI) has been considered the preferred treatment for years. The new HTORQ angle is complemented by the large lumen when accessing wall-adherent thrombus in the venous space. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo System and Lightning 12 Intelligent Aspiration Tex Heart Inst J. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Disclosures: None. Use only water-based solvents for cleaning. 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. Betsy Merryman It will reduce the service life of the PENUMBRA ENGINE. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Equipment is not safe for MR use. Figure 1. Atrium Health
Siena, Italy
CT revealed bilateral ALI (Figure 1). Figure 1. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Do not use open or damaged packages. Interventional Radiology
PEN recently announced the commercial availability of its INDIGO System Lightning 7 in the United States. 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. 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. Disclosures: None. The CAT8s large lumen can allow for efficient clot removal, which can be enhanced when paired with mechanical separation from the SEP8. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. STRIDE is the newest study from Penumbra evaluating the removal of thrombus with the Indigo Aspiration System in patients with lower extremity ALI. This procedure time has been embraced by countless interventionalists concerned about prolonged case times with other thromboaspiration technologies. Lightning enables clot detection so the physician knows when the catheter is in thrombus and when it is in patent flow. For bilateral occlusions where thrombus is laced throughout the SFA in both legs and with potential for acute-to-chronic occlusion distally, the Indigo System provides a frontline treatment option that potentially preserves limb viability. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. PENUMBRA ENGINE Indication for Use The new Indigo System is engineered to allow for thrombectomy while helping to prevent excessive blood loss during the procedure. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. The patients right leg was completely cold, insensate, and immobile from the thigh down. CAT7 and CAT12 are the next generation of the Indigo System Catheters. The wire test was done once again in the left leg, showing poor flow, a BTK clot, and evidence of chronicity. Presented at Vascular InterVentional Advances (VIVA) 2019; November 6, 2019; Las Vegas, Nevada. However, these hybrid procedures include the invasiveness of open surgery and carry the risk of incomplete thrombus removal or vessel damage.1, Consequently, many new endovascular devices have been proposed to increase treatment success, decrease complications, and rapidly improve perfusion. Executive Vice Chairman
Advancement of the CAT8 and CAT6 through the popliteal and tibial arteries (A, B). Image showing the total thrombus removed. Associate Clinical Professor, University of South Florida College of Medicine
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.