Michael S. Rosenberg, MD, FSIR, FACR Media Relations: Contraindications There are no contraindications. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Maintain a constant infusion of appropriate flush solution. This allows the operator to focus on the procedure and not on the canister. Department of Medicine, Surgery and Neuroscience Use prior to the Use By date. In summary, Lightning 12 is an excellent addition to the peripheral thrombectomy armamentarium and may allow for successful treatment of complex patients. We performed a transjugular access with a 12-F introducer sheath. Thomas S. Maldonado, MD Now, the goal with thrombus removal in PE is to safely and effectively remove thrombus and potentially reduce treatment time. The Indigo System with . o The Indigo catheters vary in diameters from 3.4Fr to 12Fr. 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. A 47-year-old woman with no previous history of thromboembolism presented with sudden-onset PE. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Continuous, sustained aspiration can effectively remove thrombus and potentially reduce the use of thrombolytics. 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. Merryman Communications Rotational thrombectomy of acute peripheral vascular occlusions using the ThromCat XT device: techniques, indications, and initial results. Precautions The device is intended or single use only. Do not resterilize or reuse. MHealth Fairview System Medical Director for Interventional Radiology Operations Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. 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. Las Vegas, Nevada Contraindications Not for use in the coronaries or the neurovasculature. The continuously powered engine pump , which is activated by a single touch, achieves a negative suction pressure of 29 inHg, a nearly pure vacuum. Stainless steel hypotube; Large lumen size and circumferential sweep enables maximized thrombus engagement; A 0.014-inch wire was used to track to the occlusion, and the Indigo System CAT6 was used to aspirate the clot (. For more information, visit https://www.penumbrainc.com/indigo-lightning/. Maintain a constant infusion of appropriate flush solution. 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. Do not use open or damaged packages. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. The CAT8s large lumen can allow for efficient clot removal, which can be enhanced when paired with mechanical separation from the SEP8. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 4. This site is protected by reCAPTCHA and the Google, Mechanical clot engagement with proprietary Separator technology, Tip directionality for circumferential aspiration, The Indigo System is an integrated system for use only with other components of the Indigo System including the CAT family of catheters, Separators, Dynamic Aspiration Tubing, Lightning, Penumbra ENGINE, and Penumbra ENGINE Canister, Lightning Intelligent Aspiration comes packaged with CAT7, CAT8 or CAT12, Live feedback during the procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister. Figure 1. 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. Lightning 12. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. 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/fibrillation; arteriovenous fistula; death; device malfunction; distal embolization; emergent surgery; false aneurysm formation; hematoma, hemorrhage, or blood loss at access site; hematoma, hemorrhage, or blood loss; hypotension; inability to completely remove thrombus or control blood flow; infection; ischemia; kidney damage from contrast media; myocardial infarction; neurological deficits including stroke; respiratory failure; thromboembolic events; vascular complications (including vessel spasm, thrombosis, intimal disruption, dissection, or perforation). The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. doi: 10.1161/CIR.0000000000000707. IVUS image showing a widely patent lumen after thrombectomy and stenting. The fundamental components of the Lightning 12 Intelligent Aspiration system are the Engine pump, the Lightning control unit, and the CAT 12 HTORQ 12F catheter. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Use only water-based solvents for cleaning. 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. Do not use open or damaged packages. PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. When in free-flowing blood, this technology automatically stops aspirating blood and hence limits unnecessary loss of blood. Do not use open or damaged packages. 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. Do not block bottom air vents. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. 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 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). . Stay informed on the week's top stories including literature summaries, device approvals, guideline changes, and more. 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. If the cause cannot be determined, withdraw the device or system as a unit. Lightning enables clot detection so the physician knows when the catheter is in thrombus and when it is in patent flow. 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. Disclosures: Owns public stock in Penumbra; consultant and course director for Penumbra, Inc. A 77-year-old woman presented to the emergency department with a history of esophageal varices and bleeding, contraindicating her for tissue plasminogen activator (tPA). 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Only use replacement fuse with correct rating (see Table 1 for fuse rating). INDIGO Aspiration System with LIGHTNING Aspiration Tubing - Indication for Use . 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. Copyright 2022 Penumbra, Inc. All rights reserved. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Contraindications Not for use in the coronaries or the neurovasculature. 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. 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. The major adverse event rate in EXTRACT-PE was 1.7%, and patients had a median intensive care unit stay of < 1 day. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Precautions The device is intended or 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. Indication For Use 2013;26: E5-7. CT revealed that the patient had a bilateral PE with an elevated RV/LV ratio of 2.26, an elevated troponin level of 0.151 g/mL, and PA pressures at 35 mm Hg. Gianmarco de Donato, MD Figure 4. Dr. Arko continued, "When dealing with thrombus, we have learned that it is the combination of the catheter along with powered aspiration that yields the most effective results. 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. 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. Manhattan Veterans Administration Hospital CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to . Figure 2. 12 F Laser Cut Hypotube Catheter. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Do not use in oxygen rich environment. Good Samaritan Hospital 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. Silver, DO, FACC, FSVM, RPVI; Catalin Toma, MD; Pavan Khanna, MD; Mitchell Weinberg, MD; and Andrew Galmer, DO. The patient, an active smoker, also had a history of pulmonary hypertension and hypercholesterolemia. In PE cases, patients are often emergent and need interventions that provide immediate relief. 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. Real-world case examples of Indigo System Lightning 12 Intelligent Aspiration for pulmonary embolism, plus insight into the science behind computer-aided mechanical aspiration and outlooks on PERT development in 2022. 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. 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. If the cause cannot be determined, withdraw the device or system as a unit. Plus, get our latest issues & supplements delivered to your inbox each month. The Indigo Aspiration System provides a treatment option that is now cleared by the FDA to treat PE. Using the Lightning 12 and SEP12 (Penumbra, Inc.), we removed a huge clot from the iliac vein with a retrograde approach to the thrombus. Equipment is not safe for MR 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 . Sponsored by Penumbra, Inc. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Intelligent Aspiration. 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. Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use. 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. The wire was removed, and the CAT8 was used to remove thrombus from the popliteal artery. Figure 2. Chief of Vascular Surgery Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Mentors and Protgs: Conversations on Career and Craft With Alda L. Tam, MD, MBA, FRCPC, FSIR, FACR, The Patient Voice in Chronic Venous Disease Treatment: What We Have and Whats Coming Next, With Kathleen Gibson, MD, FACS, FAVLS, DABVLM; Al Compaan; and Manj Gohel, MBChB, MD, FRCS, FEBVS. Venogram showing thrombosis of the left FV and CFV. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Additional information about Penumbras products can be located on Penumbras website at http://www.penumbrainc.com/healthcare-professionals. In addition to Lightning 12, the Indigo System also now includes Lightning 8 which combines the Indigo System CAT 8 Aspiration Catheter with Lightning Intelligent Aspiration for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. Warnings/Precautions The canister is intended for single use only. Lightning Intelligent Aspiration comes packaged with the Indigo CAT 8 or the newest CAT12, the next generation of the Indigo System catheters. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Do not use open or damaged packages. Lightning Intelligent Aspiration. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. The Indigo System has been designed to address the limitations of traditional treatment options. Immediately postprocedure, a decrease in PA pressure from 35 to 27 mm Hg was observed. The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE (Figure 1). Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Figure 1. Do not re-infuse blood or fluid from the canister back into the patient. Real-world use of the Indigo System Lightning 7 and Lightning 12 Intelligent Aspiration in arterial, pulmonary embolism, and venous cases. CAT12 features a large 0.131-inch lumen and angled tip for additional circumferential sweep (Figure 2). INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Precautions The device is intended for single use only. Endovascular Today (ISSN 1551-1944 print and ISSN 2689-792X online) is a publication dedicated to bringing you comprehensive coverage of all the latest technology, techniques, and developments in the endovascular field. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. In addition, the RV/LV ratio decreased from 2.26 to 1.09, over a > 50% on-table decrease. Eric Moldestad, MD Lightning was hooked up to the Indigo System Catheter CAT12 and placed into the access sheath. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Total aspiration time was 34 minutes. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. Lightning 12 and Separator 12 Now Indicated for Treatment of PE, The Indigo Aspiration System Lightning 12 received FDA clearance for the treatment of pulmonary embolism. Prior to use, please refer to the . Lightning Intelligent Aspiration allows physicians to optimize the thrombus removal needed to complete venous thrombus procedures that would otherwise be more complicated. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Disclosures: None. 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 (. Mean PA pressure postintervention was 21 mm Hg. Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. 2023 Bryn Mawr Communications II, LLC. Determining and Applying Appropriate Use of Venous Care, With Kathleen Ozsvath, MD, and Elna Masuda, MD, left-arrow 2020;59:173-218. doi: 10.1016/j.ejvs.2019.09.006. STRIDE is currently ongoing. Otherwise, this could result in degradation of the performance of this equipment. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. When 4 solid illuminated bars on the . When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. 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; and D. Chris Metzger, MD. 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. Do not use open or damaged packages. University of Siena By capturing the clot without maceration and under high aspiration power, the risk for distal emboli may be minimized. Icahn School of Medicine at Mount Sinai doi: 10.14503/THIJ-21-7571. Figure 6. 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. 2019;140:e774-e801. Precautions The device is intended for single use only. Do not use in an oxygen rich environment. Professor of Radiology and Surgery Figure 8. Lightning 12 combines the Indigo System CAT12 aspiration catheter with lightning intelligent aspiration, enabling physicians to focus on optimising thrombus removal using the system's unique clot detection mechanism. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. investors@penumbrainc.com Next Article Mean PA pressure at the start of the case was 35 mm Hg. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The means of mains disconnect is to remove the power cord. After considering the acute onset of symptoms and the history of thrombosis, we decided to proceed with the Indigo System to treat the bilateral PE in one session. Potential Adverse Events Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; 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; respiratory failure; peripheral thromboembolic events. The device is intended for single use only. 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. 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. Lightning is paired with CAT8 or CAT12. University of Minnesota Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Only use replacement fuse with correct rating (see Table 1 for fuse rating). 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. The catheters, which were initially designed for intracranial navigation for the treatment of acute stroke, are provided with an atraumatic tip. Professor, FIU Herbert Wertheim College Penumbra, the Penumbra P logo, Indigo, CAT, Separator, Lightning, and Penumbra ENGINE are trademarks of Penumbra, Inc. For more information, visit www.penumbrainc.com and connect on Twitter and LinkedIn. COVID has increased the awareness of the need for therapies that remove blood clots, and we are thrilled with the FDA clearance of the PE treatment indication for Lightning 12.. Figure 1. Enter your email address and we will contact you.
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