indigo system lightning 12

With the maximized inner diameter of 0.082 and a 7 French outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. 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. Scan showing preoperative left venous thrombus. Otherwise, this could result in degradation of the performance of this equipment. 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. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Figure 8. Penumbra augments vascular franchise with latest Indigo System launch Professor of Radiology and Surgery Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. 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. If the cause cannot be determined, withdraw the device or system as a unit. Penumbra, Inc. The Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Do not use open or damaged packages. 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. 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. 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. Resterilization and/or reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location. STRIDE is the newest study from Penumbra evaluating the removal of thrombus with the Indigo Aspiration System in patients with lower extremity ALI. Mean PA pressure at the start of the case was 35 mm Hg. At the 30-day follow-up, the patient no longer had residual shortness of breath or exertional dyspnea. Created with Sketch. Precautions The device is intended for single use only. Do not use kinked or damaged devices. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. 1. Do not resterilize or reuse. STRIDE is currently ongoing. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. The patients echocardiogram showed normal RV size and function. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Maintain a constant infusion of appropriate flush solution. Return all damaged devices and packaging to the manufacturer/distributor. Image showing the total thrombus removed. Circulation. Advancement of the CAT8 and CAT6 through the popliteal and tibial arteries (A, B). Do not use in oxygen rich environment. 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. The EXTRACT-PE trial demonstrated that the Indigo System can provide immediate mechanical relief using sustained aspiration. 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. Figure 3. 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. Of note, the patient was not a good candidate for thrombolysis due to retroperitoneal hemorrhage from lymph node biopsy several days earlier. 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. 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). Indigo System | Penumbra Inc Executive Medical Director of Interventional Radiology & Vascular Imaging Catheters & Separators. Do not use in an oxygen rich environment. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Silver, DO, FACC, FSVM, RPVI; Catalin Toma, MD; Pavan Khanna, MD; Mitchell Weinberg, MD; and Andrew Galmer, DO. of Medicine PENUMBRA ENGINE Indication for Use The latest addition to the catheter line, the CAT12, is Penumbras most torqueable and trackable catheter to date. Ask the Experts: How Do You Treat (and Avoid) Recurrent Varicose Veins? In the current treatment of PE, standard treatments such as anticoagulation, thrombolysis, and open embolectomy have limitations. 1. A preliminary analysis of the first 143 patients showed a technical success (defined as complete or near-complete revascularizationTIMI 2-3 flow) after thromboaspiration procedure alone in 89.5%. We opted for aspiration thrombectomy with the Indigo System Lightning 12 with the 100-cm HTORQ tip (Penumbra, Inc.). Lightning has also demonstrated an 18:1 potential fluid loss savings during bench top testing when used versus the Dynamic Aspiration Tubing. 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 Indigo System Lightning 12 was launched in July and is available immediately for patients needing interventional treatment for PE. 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. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Created with Sketch. 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 3. 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. Thomas S. Maldonado, MD 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). 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. Ballad Health System CVA Heart & Vascular Institute Postprocedural CT of the patients left pulmonary anatomy. 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. Total aspiration time was 34 minutes. 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 the PENUMBRA ENGINE. Sponsored by Penumbra, Inc. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Intelligent Aspiration. Do not resterilize or reuse. CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to . Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Ripal T. Gandhi, MD, FSIR, FSVM MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW Using the Lightning 12 and SEP12 (Penumbra, Inc.), we removed a huge clot from the iliac vein with a retrograde approach to the thrombus. Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. Desert Radiology The decision was made to proceed with mechanical thrombectomy. Preprocedural CT of the patients left pulmonary anatomy. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. doi: 10.1161/CIR.0000000000000707. Do not re-infuse blood or fluid from the canister back into the patient. Use prior to the Use By date. According to the American Heart Association, PE affects roughly 367,000 Americans per year.1. Real-world use of the Indigo System Lightning 7 and Lightning 12 Intelligent Aspiration in arterial, pulmonary embolism, and venous cases. Charlotte, North Carolina Equipment is not safe for MR use. Throughout each case, Lightning provides procedural feedback via audiovisual cues. Venogram showing stents in the left CIV and EIV. 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. Department of Medicine, Surgery and Neuroscience 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. Precautions The device is intended or single use only. New Indigo System By Penumbra - Medical Device News Magazine 2020;59:173-218. doi: 10.1016/j.ejvs.2019.09.006. University of Minnesota 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. 12 F Laser Cut Hypotube Catheter. Internet Explorer presents a security risk. The INDIGO SEPARATOR is not intended for use as a guidewire. Contraindications There are no known contraindications. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. With a device time of only 5 minutes and no use of tPA, the patients symptoms were promptly relieved with no recurring episodes to date. Semin Dial. Manhattan Veterans Administration Hospital Dek Z, Strube H, Sadeghi-Azandaryani M, et al. Investor Relations: Figure 2. 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. Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. Contraindications There are no contraindications. Indigo System - Vascupedia 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. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Eric Moldestad, MD With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. The SEP12 was introduced to help clear the lumen of the catheter due to the heavy thrombus burden. 2014;59:729-36. 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. 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. betsy@merrymancommunications.com This procedure time has been embraced by countless interventionalists concerned about prolonged case times with other thromboaspiration technologies. CAT 12 is a . 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. Figure 1. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 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 Aspiration Catheters to the Penumbra Aspiration Pump. Precautions The device is intended for single use only. Venogram showing CAT12 in the CIV. Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use. The Indigo System has been designed to address the limitations of traditional treatment options. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Sista A. 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. When in free-flowing blood, this technology automatically stops aspirating blood and hence limits unnecessary loss of blood. Co-Director, Aortic Institute 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. 2011;17:283-289. doi: 10.4261/1305-3825.DIR.3687-10.2, 3. 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. Figure 3. Betsy Merryman Do not use in an oxygen rich environment. Michael S. Rosenberg, MD, FSIR, FACR 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. Figure 6. Carrera LA, Reddy R, Pamoukian VN, et al. Do not use kinked or damaged devices. Sanger Heart and Vascular Institute We performed a transjugular access with a 12-F introducer sheath. Thrombotic disease puts patients at high risk of . (Photo: Business Wire). Single-session management of PE using the Indigo System CAT8 allows physicians to treat emergent patients. 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. 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. The Indigo CAT12 represents an advancement in mechanical thrombectomy given its ability to aspirate large-volume thrombus in a single-session setting, which is especially beneficial in larger-lumen vascular beds, such as large-caliber veins as demonstrated in this case. 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. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Disclosures: None. 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 . 2013;26: E5-7. Individual results may vary depending on patient-specific attributes. Lightning 12 combines the Indigo System CAT12 Aspiration Catheter with . 1. Lightning enables clot detection so the physician knows when . Circulation. Industry Prospects Made of laser-cut hypotube technology, the CAT12 is Penumbras most trackable and torqueable catheter to date. Precautions The device is intended or single use only. Poor flow through the left TPT. 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 Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. For more information, visit https://www.penumbrainc.com/indigo-lightning/. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. right-arrow Penumbra Announces the European Launch of the Indigo System With The patient also had a history of bilateral PE dating back to October 2017, at which point rivaroxaban was prescribed. J Vasc Surg. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Intraoperative angiography can identify any arterial imperfection after surgical thromboembolectomy, which may be corrected simultaneously by endovascular techniques. Next Article 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. IVUS image showing May-Thurner narrowing of the left CIV and thrombus in the iliac vein. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. Indication For Use Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. LIGHTNING Aspiration Tubing Indication for Use 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. This website is intended for US audience only. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 2019;140:e774-e801. In this case, the PE patient had an extremely high PA pressure of 35 mm Hg, which we were able to significantly reduce by 40%. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. 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. 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. 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. No modification of this equipment is allowed. Return all damaged devices and packaging to the manufacturer/distributor. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. 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. Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with . The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Angiography showed the presence of a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism tibial (A) and plantar arteries (B). Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Learn more about Lightning. Diagn Interv Radiol. The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE (Figure 1). Chief of Vascular Surgery Do not resterilize or reuse. Created with Sketch. Figure 1. 310-560-8176. Editors choiceEuropean Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the management of acute limb ischemia. According to Penumbra, Lightning 12 combines the company's new Indigo System Cat 12 aspiration catheter with its Lightning Intelligent Aspiration to enable physicians to focus on optimizing thrombus removal using the systems clot detection mechanism. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use 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. 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. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. A 0.014-inch wire was used to track to the occlusion, and the Indigo System CAT6 was used to aspirate the clot (. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. (Credit: Business Wire.) Contraindications There are no known contraindications. It will reduce the service life of the PENUMBRA ENGINE. 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. Penumbra Announces U.S. Commercial Availability of INDIGO System

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