Chief, Vascular and Endovascular Surgery Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. 2. 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. Precautions The device is intended or single use only. 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. Return all damaged devices and packaging to the manufacturer/ distributor. 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. 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. By capturing the clot without maceration and under high aspiration power, the risk for distal emboli may be minimized. Do not use open or damaged packages. Notably, Lightning 7 is designed . Return all damaged devices and packaging to the manufacturer/distributor. The Indigo Aspiration System, along with the Penumbra ENGINE and Indigo CAT8, provide a frontline treatment option for PE patients that can lower on-table PA pressures and reduce RV/LV ratios by 27.3%, per their investigational device exemption trial, EXTRACT-PE.1 The trial and our case experience at the University of Minnesota with CAT8 show that sustained aspiration with the Indigo System can provide safe mechanical relief in the treatment of PE. Manhattan Veterans Administration Hospital If repositioning of the INDIGO CAT RX Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard guidewire techniques. Disclosures: None. Associate Professor of Vascular Surgery IVUS image showing May-Thurner narrowing of the left CIV and thrombus in the iliac vein. 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. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. o The Indigo catheters vary in diameters from 3.4Fr to 12Fr. The Indigo Separator is advanced and retracted through the corresponding size Indigo catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip. The Indigo CAT12 Aspiration Catheter is indicated for removal of fresh, soft emboli and thrombi from vessels of the peripheral venous systems. The Indigo System with Lightning Intelligent Aspiration and Separators is indicated for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous . Sanger Heart and Vascular Institute Precautions The device is intended for single use only. 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. Do not use open or damaged packages. Traditionally, tPA or open embolectomy were the primary treatment options for acute-to-chronic lesions. As part of the Indigo Aspiration System, Lightning 12 (Indigo System CAT 12 Aspiration Catheter with Lightning Intelligent Aspiration) and Separator 12 are now indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems as well as for the treatment of pulmonary embolism. It is a welcome addition to our existing endovascular technologies for the treatment of acute PE. Figure 2. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Penumbras IndigoAspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. Do not block bottom air vents. 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. 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. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Precautions The device is intended for single use only. This new thromboaspiration technology allows for clot removal and potential reduction in right heart and PA pressure. Otherwise, this could result in degradation of the performance of this equipment. Otherwise, this could result in degradation of the performance of this equipment. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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 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 Indigo CAT8 XTORQ was advanced over the select catheter and used in both the right and left PAs. Advancement of the CAT8 and CAT6 through the popliteal and tibial arteries (A, B). Miami Cancer Institute Director, Venous Thromboembolic Center and Aortic Center Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Lightning is paired with CAT8 or CAT12. Figure 2. Betsy Merryman 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 Penumbra Indigo System Separator is intended for use with our Indigo Systems CAT family of catheters to enable the removal of a wide range of thrombus. Circulation. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. CAT7 and CAT12 are the next generation of the Indigo System Catheters. At the 30-day follow-up, the patient no longer had residual shortness of breath or exertional dyspnea. Created with Sketch. Figure 2. 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. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Schwartz-Buckley Professor of Surgery, Vascular Division In PE cases, patients are often emergent and need interventions that provide immediate relief. Do not resterilize or reuse. An intuitive clicking sound is made by the device that signals that one is in free-flowing blood. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. 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. Maintain a constant infusion of appropriate flush solution. 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. Figure 2. 1. de Donato G, Setacci F, Sirignano P, Galzerano G, Massaroni R, Setacci C. The combination of surgical embolectomy and endovascular techniques may improve outcomes of patients with acute lower limb ischemia. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. The results may not be predictive of all patients. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. CAT 12 is a . Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 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. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Figure 3. Stainless steel hypotube; Large lumen size and circumferential sweep enables maximized thrombus engagement; 2020;141(9):e139e596. PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW. PEN recently announced the commercial availability of its INDIGO System Lightning 7 in the United States. The decision was made to proceed with mechanical thrombectomy. A 48-year-old man presented with a 3-day history of acute shortness of breath and chest pressure. 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. Next Article The Lightning 12 addition to the Indigo Aspiration System is a formative development in the thrombectomy space. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 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. Industry Prospects Throughout each case, Lightning provides procedural feedback via audiovisual cues. 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 reuse. 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. INDIGO Aspiration System with LIGHTNING Aspiration Tubing - Indication for Use . Professor, Cardiovascular Surgery The Separator is specifically designed for mechanical clot engagement and is particularly helpful in acute-on-chronic thrombosis, in-stent/in-bypass fresh occlusion, and in below-the-knee (BTK) and all the way to the pedal arch thrombi localization (Figure 1). Do not use kinked or damaged devices. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Executive Medical Director of Interventional Radiology & Vascular Imaging 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. Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. Atrium Health Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with . Program Director, Vascular Fellowship & Integrated Residency STRIDE is the newest study from Penumbra evaluating the removal of thrombus with the Indigo Aspiration System in patients with lower extremity ALI. New York University Langone Medical Center The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE . 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. Angiography showed the presence of a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism tibial (A) and plantar arteries (B). Cincinnati, Ohio Restored distal flow to the left TPT. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 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. CT showed a bilateral PE with right heart strain. 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. 2018;29:92-100. doi: 10.1016/j.jvir.2017.08.019. Catheters & Separators. 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. COURSE OF TREATMENT. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Presented at Vascular InterVentional Advances (VIVA) 2019; November 6, 2019; Las Vegas, Nevada. Do not use open or damaged packages. In summary, Lightning 12 is an excellent addition to the peripheral thrombectomy armamentarium and may allow for successful treatment of complex patients. Do not block bottom air vents. 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. Pulmonary embolism, or PE, is a deadly condition causing blood clots within a patients lungs that has grown in prevalence during the COVID-19 pandemic. It will reduce the service life of the PENUMBRA ENGINE. 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. Image of thrombus aspirated using the Indigo CAT12 Aspiration Catheter. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Precautions The device is intended or single use only. Venogram showing CAT12 in the CIV. Associate Clinical Professor, University of South Florida College of Medicine The wire was removed, and the CAT8 was used to remove thrombus from the popliteal artery. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. 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. Semin Dial. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Using the HTORQ angle on CAT12 to torque the catheter, several passes were made through the affected area, from the left popliteal to the external iliac vein (EIV) and internal iliac vein. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. The SEP12 was introduced to help clear the lumen of the catheter due to the heavy thrombus burden. 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. Diagn Interv Radiol. Warnings/Precautions The canister is intended for single use only. Do not use kinked or damaged devices. In my radiology practice, Ive seen firsthand the challenges medical practitioners face while treating difficult medical conditions, stated Dr. Teigen in the announcement. The system is indicated for the removal of fresh, soft emboli and thrombi . 2013;26: E5-7. Figure 4. The 1:1 torqueability of the catheter was especially valuable for aspirating thrombus along the circumference of the larger-diameter iliac veins. Do not use open or damaged packages. Lightning Intelligent Aspiration. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Warnings/Precautions The canister is intended for single use only. 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. It is low-profile and deliverable to all vascular territories in the pulmonary circulation. Now, the goal with thrombus removal in PE is to safely and effectively remove thrombus and potentially reduce treatment time. When 4 solid illuminated bars on the . Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Access was gained using an 8-F sheath in the left popliteal vein, which was then upsized to a 12-F sheath. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Sponsored by Penumbra, Inc. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Intelligent Aspiration. CAT3 advanced through the pedal loop (C). 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 (. The primary outcome is the rate of TIMI 2-3 revascularization after treatment using the Indigo System. This allows the operator to focus on the procedure and not on the canister. Do not re-infuse blood or fluid from the canister back into the patient. The INDIGO SEPARATOR is not intended for use as a guidewire. Do not use kinked or damaged devices. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Plus, get our latest issues & supplements delivered to your inbox each month. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Lightning enables clot detection so the physician knows when . The Indigo System Lightning 12 is the companys newest generation aspiration system for peripheral thrombectomy. 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. Ripal T. Gandhi, MD, FSIR, FSVM 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. Sustained aspiration from the Indigo System provides physicians with an alternative option for patients who are not ideal candidates for lytics or open embolectomy and provides a frontline therapy option that still preserves the use of any adjunctive therapy. Image showing the total thrombus removed. Disclosures: None. The CAT familyof catheters is the foundation of Penumbras Indigo System. 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. 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. 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 5. CAT12 is . Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 2020;59:173-218. doi: 10.1016/j.ejvs.2019.09.006. Lightning 7 a and Lightning 12 a are made of laser-cut hypotube technology, designed to increase trackability and torqueability. 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. The latest addition to the catheter line, the CAT12, is Penumbras most torqueable and trackable catheter to date. Department of Medicine, Surgery and Neuroscience Mean PA pressure at the start of the case was 35 mm Hg. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. 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. Miami Vascular Specialists 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 . MHealth Fairview System Medical Director for Interventional Radiology Operations Eur J Vasc Endovasc Surg. Scan showing preoperative left venous thrombus. Carrera LA, Reddy R, Pamoukian VN, et al. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Copyright 2022 Penumbra, Inc. All rights reserved. Poor distal runoff from acute thrombus. The new Indigo System is engineered to allow for thrombectomy while helping to prevent excessive blood loss during the procedure. Placing guidewire too distal in the pulmonary vasculature or excessive manipulation of aspiration/ guiding catheter in the smaller, peripheral, and segmental pulmonary artery branches can result in vessel perforation. Figure 1. Immediately postprocedure, a decrease in PA pressure from 35 to 27 mm Hg was observed. In addition, the RV/LV ratio decreased from 2.26 to 1.09, over a > 50% on-table decrease. The PRISM trial, a retrospective case analysis assessing the rate of TIMI 2-3 flow after the use of Indigo and specifically the XTRACT technique, showed an 87.2% rate of revascularization post-Indigo and subsequent treatment of underlying stenosis in the same setting.1 The newly completed study studying the same primary outcome as PRISM, the INDIAN registry, showed an even higher rate of revascularization, 88.7%.2 Sustained aspiration for ALI could potentially increase the revascularization rate by serving as an effective single-session frontline option. Co-Director, Aortic Institute All Rights Reserved Privacy Policy. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. J Vasc Interv Radiol. 2014;59:729-36. LIGHTNING Aspiration Tubing Indication for Use Return all damaged devices and packaging to the manufacturer/distributor.
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