The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. 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. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. Notably, Lightning 7 is designed . rosen011@umn.edu The acute pulmonary embolism (PE) treatment paradigm is evolving to treat patients that have emergent symptoms and are unable to tolerate long thromboaspiration procedures. Interventional Radiology 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 . PENUMBRA ENGINE Indication for Use 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). Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. 2. Associate Clinical Professor, University of South Florida College of Medicine Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Disclosures: None. (EXTRACT-PE). Investor Relations: 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 . 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. Contraindications Not for use in the coronaries or the neurovasculature. Engineered to be trackable, deliverable, and torqueable, the CAT8s atraumatic tip can navigate the lobar anatomy of the PA to help establish inflow and outflow, helping to restore patient vitals to normal. 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. 2013;26: E5-7. Otherwise, this could result in degradation of the performance of this equipment. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Determining and Applying Appropriate Use of Venous Care, With Kathleen Ozsvath, MD, and Elna Masuda, MD, left-arrow Learn more about Lightning. 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 thromboaspiration with the Indigo System was particularly useful in situations of multilevel vessel acute occlusion. 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. 2019;140:e774-e801. Disclosures: Consultant to Penumbra, Inc. A 68-year-old man presented with a sudden coolness in both legs after stopping apixaban therapy for 3 days. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. Program Director, Vascular Fellowship & Integrated Residency 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Scan showing preoperative left venous thrombus. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Miami, Florida Risk Information. Enter your email address and we will contact you. Do not resterilize or reuse. 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. 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 Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Mean PA pressure postintervention was 21 mm Hg. 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. Frank R. Arko III, MD Professor of Radiology and Surgery When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Individual results may vary depending on patient-specific attributes. Disclosures: None. The system designed to reduce blood loss and the need for clot-dissolving drugs, which . Contraindications There are no known contraindications. Evaluating the safety and efficacy of the Indigo aspiration system in acute pulmonary embolism. Icahn School of Medicine at Mount Sinai Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. PEN recently announced the commercial availability of its INDIGO System Lightning 7 in the United States. Do not use in oxygen rich environment. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Use prior to the Use By date. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. We gained access through the right CFV using a 14-F sheath. The Indigo System Lightning 12 was launched in July and is available immediately for patients needing interventional treatment for PE. . 1. 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). Do not re-infuse blood or fluid from the canister back into the patient. Betsy Merryman Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The latest addition to the catheter line, the CAT12, is Penumbras most torqueable and trackable catheter to date. Heart disease and stroke statistics2020 update: a report from the American Heart Association. Maintain a constant infusion of appropriate flush solution. Using the Lightning 12 and SEP12 (Penumbra, Inc.), we removed a huge clot from the iliac vein with a retrograde approach to the thrombus. Do not use open or damaged packages. Lightning Intelligent Aspiration. With the severity of this patients symptoms, immediate relief was required to maintain limb viability and the different profiles of the Indigo catheters provided a complete portfolio for aspiration in the arterial vasculature, starting with the CAT8 in the SFA and BTK to using the CAT RX coaxially in the heavily diseased TPT. Use prior to the Use By date. Venogram showing CAT12 in the CIV. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. This procedure time has been embraced by countless interventionalists concerned about prolonged case times with other thromboaspiration technologies. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. After adjunctive endovascular (angioplasty, stenting, or lysis), TIMI 2-3 was reached in up to 95.3% of patients. 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 and Separator 12 Now Indicated for Treatment of PE, The Indigo Aspiration System Lightning 12 received FDA clearance for the treatment of pulmonary embolism. Precautions The device is intended for single use only. 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. From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event. The patients echocardiogram showed normal RV size and function. Plus, get our latest issues & supplements delivered to your inbox each month. 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. Precautions The device is intended for single use only. The Indigo Aspiration System is comprised of several devices: The Indigo System is used as a first-line approach or rescue therapy for arterial and venous thrombotic events. 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. 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. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Sponsored by Penumbra, Inc. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Intelligent Aspiration. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Giri J, Sista A, Weinberg I, et al. Figure 3. right-arrow Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. The 1:1 torqueability of the catheter was especially valuable for aspirating thrombus along the circumference of the larger-diameter iliac veins. Figure 3. Postprocedural CT of the patients left pulmonary anatomy. CAT7 and CAT12 are the next generation of the Indigo System Catheters. Do not resterilize or reuse. Cincinnati, Ohio Prior to use, please refer to the . 510-995-2461 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. Circulation. doi: 10.1161/CIR.0000000000000707. Made of laser-cut hypotube technology, the CAT12 is Penumbras most trackable and torqueable catheter to date. 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. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 2021 Nov 1;48(5):e217571. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Immediately postprocedure, a decrease in PA pressure from 35 to 27 mm Hg was observed. 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). It is a welcome addition to our existing endovascular technologies for the treatment of acute PE. Do not use open or damaged packages. Atrium Health The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. 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 advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. The INDIGO SEPARATOR is not intended for use as a guidewire. Indication For Use Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into 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; 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. 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. Sanger Heart and Vascular Institute 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. Otherwise, this could result in degradation of the performance of this equipment. 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). 2. 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. 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. Return all damaged devices and packaging to the manufacturer/ distributor. Do not use kinked or damaged devices. Return all damaged devices and packaging to the manufacturer/distributor. 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. (Credit: Business Wire.) 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. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. The wire was removed, and the CAT8 was used to remove thrombus from the popliteal artery. 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. IVUS image showing a widely patent lumen after thrombectomy and stenting. Return all damaged devices and packaging to the manufacturer/ distributor. 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. 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). Figure 2. Disclosures: Consultant to Penumbra, Inc. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. This website is intended for US audience only. Penumbra, Inc. Mean PA pressure at the start of the case was 35 mm Hg. Restored distal flow to the left TPT. Author S Jay Mathews 1 Affiliation 1 Bradenton Cardiology Center, Manatee . Figure 4. Postoperative angiogram showing 100% resolution of thrombus. CT revealed bilateral ALI (Figure 1). Do not resterilize or reuse. Stainless steel hypotube; Large lumen size and circumferential sweep enables maximized thrombus engagement; 1. When in free-flowing blood, this technology automatically stops aspirating blood and hence limits unnecessary loss of blood. Created with Sketch. The means of mains disconnect is to remove the power cord. Figure 1. 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. 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. Do not use open or damaged packages. Saxon RR, Benenati JF, Teigen C, et al. 12 F Laser Cut Hypotube Catheter. 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. CAT12 is a large . The Indigo CAT12 Aspiration Catheter is indicated for removal of fresh, soft emboli and thrombi from vessels of the peripheral venous systems. Massive intravascular hemolysis with mechanical rheolytic thrombectomy of a hemodialysis arteriovenous fistula. Miami Cardiac and Vascular Institute The Indigo Aspiration System provides a treatment option that is now cleared by the FDA to treat PE. Department of Diagnostic, Molecular, and Interventional Radiology Use prior to the Use By date. 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. Of note, the patient was not a good candidate for thrombolysis due to retroperitoneal hemorrhage from lymph node biopsy several days earlier. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to . Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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 computer-aided clot detection technology that can differentiate between clot and blood.