doi: 10.14503/THIJ-21-7571. Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. Although motor function was still intact, there was decreased sensation and delayed capillary refill in the left foot and calf. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Lightning Intelligent Aspiration comes packaged with the Indigo CAT 8 or the newest CAT12, the next generation of the Indigo System catheters. IVUS image showing May-Thurner narrowing of the left CIV and thrombus in the iliac vein. Diagn Interv Radiol. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 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. The Lightning 12 addition to the Indigo Aspiration System is a formative development in the thrombectomy space. Miami Cancer Institute
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. Precautions The device is intended or single use only. For more information, visit https://www.penumbrainc.com/indigo-lightning/. Enter your email address and we will contact you. Miami, Florida
The EXTRACT-PE study completed in 2019 evaluated the safety and efficacy of the Indigo Aspiration System in the management of submassive PE. Contraindications There are no known contraindications. Figure 3. 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. 2020;141(9):e139e596. Contraindications There are no known contraindications. This procedure time has been embraced by countless interventionalists concerned about prolonged case times with other thromboaspiration technologies. A 67-year-old woman with a history of venous thrombus and iliac venous stenting presented with significant recurrent left lower extremity venous thrombus, and the patients symptoms did not significantly improve with anticoagulation alone. 5. New York, New York
The Indigo System with . Continuous, sustained aspiration can effectively remove thrombus and potentially reduce the use of thrombolytics. Sanger Heart and Vascular Institute
Otherwise, this could result in degradation of the performance of this equipment. The patient, an active smoker, also had a history of pulmonary hypertension and hypercholesterolemia.
[email protected] 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Presented at Vascular InterVentional Advances (VIVA) 2019; November 6, 2019; Las Vegas, Nevada. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Program Director, Vascular Fellowship & Integrated Residency
Department of Medicine, Surgery and Neuroscience
Gianmarco de Donato, MD
Created with Sketch. Thrombolysis is not a universal option for all patient groups, especially if the patient has an absolute or relative contraindication to a fibrinolytic agent. Venogram showing stents in the left CIV and EIV. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. 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. 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. 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. Department of Diagnostic, Molecular, and Interventional Radiology
INDIGO Aspiration System with LIGHTNING Aspiration Tubing - Indication for Use . Lightning 12 Intelligent Aspiration. 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. Disclosures: None. Angiography showed the presence of a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism tibial (A) and plantar arteries (B). Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. However, it has also been associated with an unsatisfying revascularization rate due to the detection of residual thrombus in distal vessels. Figure 8. Traditionally, tPA or open embolectomy were the primary treatment options for acute-to-chronic lesions. CT revealed bilateral ALI (Figure 1). Large-bore embolectomy, when paired with a syringe, has led to variable results, with questions regarding the ideal technique to achieve a uniform state of vacuum aspiration.1 The catheters used to aspirate should ideally be atraumatic and easily deliverable to be able to access and establish flow through the lobar branches of the pulmonary artery (PA), reducing right heart strain and PA pressure. Industry Prospects Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use In PE cases, patients are often emergent and need interventions that provide immediate relief. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. Do not resterilize or reuse. Potential adverse . Do not use kinked or damaged devices. J Vasc Interv Radiol. Lightning 12 combines the Indigo System CAT12 Aspiration Catheter with . The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to provide advanced deliverability and torqueability within the body. The Indigo Aspiration System is comprised of several devices: The Indigo System is used as a first-line approach or rescue therapy for arterial and venous thrombotic events. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. CAT12 features a large 0.131-inch lumen and angled tip for additional circumferential sweep (Figure 2). 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). Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. This new thromboaspiration technology allows for clot removal and potential reduction in right heart and PA pressure. The latest generation of Penumbras continuous aspiration thrombectomy system features Indigo System Lightning 12 which combines the new Indigo System CAT 12 Aspiration Catheter with Lightning Intelligent Aspiration powered by Penumbra ENGINE, enabling physicians to focus on optimizing thrombus removal using the systems unique clot detection mechanism. Do not resterilize or reuse. 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. 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. Miami Cardiac and Vascular Institute
Betsy Merryman Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The system is indicated for the removal of fresh, soft emboli and thrombi . Minneapolis, Minnesota
Do not use in oxygen rich environment. 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 . Use prior to the Use By date. With the severity of this patients symptoms, immediate relief was required to maintain limb viability and the different profiles of the Indigo catheters provided a complete portfolio for aspiration in the arterial vasculature, starting with the CAT8 in the SFA and BTK to using the CAT RX coaxially in the heavily diseased TPT. Figure 6. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. Plus, get our latest issues & supplements delivered to your inbox each month. Return all damaged devices and packaging to the manufacturer/distributor. 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The catheter is robust and trackable, and the large lumen allows for thrombectomy either with a guidewire in place or without a guidewire. The new HTORQ angle is complemented by the large lumen when accessing wall-adherent thrombus in the venous space. 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. Las Vegas, Nevada
Thomas S. Maldonado, MD
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. IVUS image showing a widely patent lumen after thrombectomy and stenting. Preliminary data from the INDIAN registry is promising regarding early safety and efficacy for the revascularization of acute peripheral arterial occlusions with thromboaspiration as primary therapy. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. 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. Do not use in an oxygen rich environment. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo System and Lightning 12 Intelligent Aspiration Tex Heart Inst J. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. CT showed a bilateral PE with right heart strain. Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with . Professor, Cardiovascular Surgery
right-arrow Equipment is not safe for MR use. Penumbra, Inc. Do not resterilize or reuse. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Poor distal runoff from acute thrombus. Professor, FIU Herbert Wertheim College
As presented on November 21, 2019, at VEITH 2019 by Dr. Gianmarco de Donato, University of Siena, Italy. 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. A 47-year-old woman with no previous history of thromboembolism presented with sudden-onset PE. 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 Indigo CAT8 XTORQ was advanced over the select catheter and used in both the right and left PAs. Disclosures: None. Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. Figure 2. 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. 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. 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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