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Do not resterilize or reuse. Warnings/Precautions The canister is intended for single use only. This combination of intelligent aspiration and large-lumen catheter engineering forms Lightning 12: the latest generation in clot removal technology. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. Designed for single session arterial thrombus removal, New angled tip shape for maximized clot extraction, Dual pressure sensors for real-time flow monitoring, Large lumen size and circumferential sweep enables maximized thrombus engagement, Multi-pitch hypotube for 1:1 torque transfer and advanced deliverability, Indicated for the treatment of pulmonary embolism. 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. Department of Diagnostic, Molecular, and Interventional Radiology Michael S. Rosenberg, MD, FSIR, FACR 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. Co-Director, Aortic Institute It is low-profile and deliverable to all vascular territories in the pulmonary circulation. Access was gained through the groin using an 8-F Destination sheath (Terumo Interventional Systems). 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. Eric Moldestad, MD Continuous, sustained aspiration can effectively remove thrombus and potentially reduce the use of thrombolytics. CAT 12 is a . right-arrow 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. Created with Sketch. To prevent fire or shock hazard, use a replacement power cord of equal rating. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Plus, get our latest issues & supplements delivered to your inbox each month. Advancement of the CAT8 and CAT6 through the popliteal and tibial arteries (A, B). At the 30-day follow-up, the patient no longer had residual shortness of breath or exertional dyspnea. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Created with Sketch. Disclosures: None. New York University Langone Medical Center Use prior to the Use By date. Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Indication For Use Chief of Vascular Surgery 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. Contraindications Not for use in the coronaries or the neurovasculature. This website is intended for US audience only. Created with Sketch. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Notably, Lightning 7 is designed . Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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. The catheters, which were initially designed for intracranial navigation for the treatment of acute stroke, are provided with an atraumatic tip. 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. 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). 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. Figure 3. Made of laser-cut hypotube technology, the CAT12 is Penumbras most trackable and torqueable catheter to date. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Investor Relations: Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Manhattan Veterans Administration Hospital Do not re-infuse blood or fluid from the canister back into the patient. 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. When in free-flowing blood, this technology automatically stops aspirating blood and hence limits unnecessary loss of blood. 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. Otherwise, this could result in degradation of the performance of this equipment. 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 . Figure 1. February 2022. We opted for aspiration thrombectomy with the Indigo System Lightning 12 with the 100-cm HTORQ tip (Penumbra, Inc.). 2018;29:92-100. doi: 10.1016/j.jvir.2017.08.019. 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. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Disclosures: None. 1. 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. Figure 1. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Figure 2. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Created with Sketch. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Blood clots in the lungs can block the lungs from absorbing oxygen, causing strain on the heart and other organs. Restored distal flow to the left TPT. New York, New York Associate Clinical Professor, University of South Florida College of Medicine New York, New York Do not resterilize or reuse. Low-dose tPA was dripped into the left and right lobes of the PA. 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. Precautions The device is intended or single use only. Although motor function was still intact, there was decreased sensation and delayed capillary refill in the left foot and calf. Icahn School of Medicine at Mount Sinai Do not use kinked or damaged devices. In the current treatment of PE, standard treatments such as anticoagulation, thrombolysis, and open embolectomy have limitations. Preprocedural CT of the patients left pulmonary anatomy. Contraindications There are no contraindications. Upon arrival to the hospital, physical examination and a Doppler ultrasound examination revealed absent pulses in the left foot. STRIDE is the newest study from Penumbra evaluating the removal of thrombus with the Indigo Aspiration System in patients with lower extremity ALI. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. The means of mains disconnect is to remove the power cord. In this next phase, Penumbra is set to broaden its reach on a global scale, and I am thrilled to join this excellent team and help accelerate the impact of its products.. 12 F Laser Cut Hypotube Catheter. The means of mains disconnect is to remove the power cord. 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. Carrera LA, Reddy R, Pamoukian VN, et al. Industry Prospects 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. Do not reuse. 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. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Precautions The device is intended for single use only. As PE treatment options continue to grow, the EXTRACT-PE results with the Indigo System serve as a promising data set in helping move the PE landscape forward. doi: 10.14503/THIJ-21-7571. The Indigo Aspiration System with Lightning 12 removes these difficult-to-access, life-threatening clots, potentially reducing the need for thrombolytics and their associated ICU stays. Additional information about Penumbras products can be located on Penumbras website at http://www.penumbrainc.com/healthcare-professionals. All Rights Reserved Privacy Policy. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. The EXTRACT-PE trial demonstrated that the Indigo System can provide immediate mechanical relief using sustained aspiration. Only use replacement fuse with correct rating (see Table 1 for fuse rating). The Indigo CAT12 Aspiration Catheter is indicated for removal of fresh, soft emboli and thrombi from vessels of the peripheral venous systems. 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. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. The Indigo Aspiration System Lightning 12 granted FDA approval. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. . 310-560-8176. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. INDIGO Aspiration System Indication for Use Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with . Figure 1. Now, the goal with thrombus removal in PE is to safely and effectively remove thrombus and potentially reduce treatment time. 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. 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 use in oxygen rich environment. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. It will reduce the service life of the PENUMBRA ENGINE. 2. Atrium Health Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. The patient, an active smoker, also had a history of pulmonary hypertension and hypercholesterolemia. Individual results may vary depending on patient-specific attributes. . Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. IVUS image showing a widely patent lumen after thrombectomy and stenting. Cincinnati, Ohio When 4 solid illuminated bars on the . INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use The on-table PA pressures were statistically reduced, and the median device time was 37 minutes. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Using the Lightning 12 and SEP12 (Penumbra, Inc.), we removed a huge clot from the iliac vein with a retrograde approach to the 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. Learn more about Lightning. Fluoroscopy showed additional thrombus in the tibioperoneal trunk (TPT) (, Final fluoroscopy of the left leg showed restored distal runoff (. 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. Thrombotic disease puts patients at high risk of . Do not use open or damaged packages. 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. Lightning 12 Intelligent Aspiration. Sponsored by Penumbra, Inc. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Intelligent Aspiration. The Indigo System has demonstrated high rates of revascularization with consistent success. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. No modification of this equipment is allowed. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Figure 6. The INDIGO SEPARATOR is not intended for use as a guidewire.