The patients echocardiogram showed normal RV size and function. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. 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 . CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to . Individual results may vary depending on patient-specific attributes. Stay informed on the week's top stories including literature summaries, device approvals, guideline changes, and more. Figure 1 shows a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism in the tibial and plantar arteries. 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. Diagn Interv Radiol. 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. Associate Clinical Professor, University of South Florida College of Medicine 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. 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. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. A 57-year-old man presented with acute-onset left calf pain for the past 10 days and had recently taken a 4-hour flight. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Lightning enables clot detection so the physician knows when . Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Localization of the thrombus was quite variable in our cohort of patients, although in the majority of cases (67%), patients presented with thrombus in the popliteal or BTK vessels. 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. on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. The acute pulmonary embolism (PE) treatment paradigm is evolving to treat patients that have emergent symptoms and are unable to tolerate long thromboaspiration procedures. 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%. Immediately after, Lightning with the Indigo System Catheter CAT8 was used to aspirate thrombus in the left PA (, Due to increased amounts of thrombus in the right lobe, the SEP8 was introduced to clear the lumen of the catheter (. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. The Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. 2019;140:e774-e801. Penumbra continues to strive to bring innovative therapies to the medical community, and this is another important milestone that will help advance pulmonary embolism intervention, said Adam Elsesser, president and chief executive officer, Penumbra. Determining and Applying Appropriate Use of Venous Care, With Kathleen Ozsvath, MD, and Elna Masuda, MD, left-arrow Otherwise, this could result in degradation of the performance of this equipment. LIGHTNING Aspiration Tubing Indication for Use Do not use open or damaged packages. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. The means of mains disconnect is to remove the power cord. 2011;17:283-289. doi: 10.4261/1305-3825.DIR.3687-10.2, 3. Ballad Health System CVA Heart & Vascular Institute There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Notably, Lightning 7 is designed . Lightning 12 combines the new Indigo System CAT12 aspiration catheter with Lightning intelligent aspiration, enabling physicians to focus on optimising thrombus removal using the system's clot detection mechanism. 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. Lightning Intelligent Aspiration comes packaged with the Indigo CAT 8 or the newest CAT12, the next generation of the Indigo System catheters. When the catheter is engaged on thrombus or embolic material, the clicking sound ceases. Miami Cardiac and Vascular Institute Use prior to the Use By date. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Do not reuse. Contraindications Not for use in the coronaries or the neurovasculature. Learn more about Lightning. Contraindications Not for use in the coronaries or the neurovasculature. The Indigo Aspiration System Lightning 12 granted FDA approval. 2021 Nov 1;48(5):e217571. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. The system is indicated for the removal of fresh, soft emboli and thrombi . A 48-year-old man presented with a 3-day history of acute shortness of breath and chest pressure. Restored distal flow to the left TPT. 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 . 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. Professor, Cardiovascular Surgery Sanger Heart and Vascular Institute Image showing the total thrombus removed. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use 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. Charlotte, North Carolina 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 safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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. University of Minnesota Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. 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 . 1. Maintain a constant infusion of appropriate flush solution. INDIGO Aspiration System with LIGHTNING Aspiration Tubing - Indication for Use . 310-560-8176. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Use prior to the Use By date. Warnings/Precautions The canister is intended for single use only. CT revealed bilateral ALI (Figure 1). 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 resterilize or reuse. 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. Powered by the Penumbra ENGINE , Lightning 7 and Lightning 12 combine the new Indigo System CAT7 and CAT12 Aspiration Catheters with Lightning Intelligent Aspiration, a unique computer-aided clot detection technology that can differentiate between clot and blood, designed to reduce blood loss and the need for clot-dissolving drugs, which . Lightning is paired with CAT8 or CAT12. Do not use open or damaged packages. Lightning is paired with CAT8 or CAT12. rosen011@umn.edu 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. Do not resterilize or reuse. Venogram showing CAT12 in the CIV. Penumbra's Indigo Aspiration System Lightning 12 received FDA clearance for the treatment of pulmonary embolism. Return all damaged devices and packaging to the manufacturer/distributor. The wire was removed, and the CAT8 was used to remove thrombus from the popliteal artery. Industry Prospects Director, Venous Thromboembolic Center and Aortic Center . 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. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo System and Lightning 12 Intelligent Aspiration Tex Heart Inst J. Henderson Hospital 2. To prevent fire or shock hazard, use a replacement power cord of equal rating. 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). 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. 2. 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. Vessel patency is assessed using the thrombolysis in myocardial infarction (TIMI) score classifications, both before and after the use of the device. 4 min read. Do not use the INDIGO Aspiration System with a pump other than the 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. Precautions The device is intended for single use only. The decision was made to proceed with mechanical thrombectomy. Thrombolysis is not a universal option for all patient groups, especially if the patient has an absolute or relative contraindication to a fibrinolytic agent. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Investor Relations: 4. CAT7 and CAT12 are the next generation of the Indigo System Catheters. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. 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. The patient, an active smoker, also had a history of pulmonary hypertension and hypercholesterolemia. The device is intended for single use only. Indication For Use If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Department of Medicine, Surgery and Neuroscience New York, New York 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. The wire test was done once again in the left leg, showing poor flow, a BTK clot, and evidence of chronicity. 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. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. As presented on November 21, 2019, at VEITH 2019 by Dr. Gianmarco de Donato, University of Siena, Italy. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Professor, FIU Herbert Wertheim College CAT 12 is a . Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Access was gained through the groin using an 8-F Destination sheath (Terumo Interventional Systems). 2020;59:173-218. doi: 10.1016/j.ejvs.2019.09.006. Penumbra, Inc. 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. Do not re-infuse blood or fluid from the canister back into the patient. 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. Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. Lightning 12 combines the 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. Advancement of the CAT8 and CAT6 through the popliteal and tibial arteries (A, B). Professor of Radiology and Surgery The Indigo System has demonstrated high rates of revascularization with consistent success. doi: 10.1111/j.1525-139X.2012.01104.x. Do not use kinked or damaged devices. 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 resterilize or reuse. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Plus, get our latest issues & supplements delivered to your inbox each month. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. To gain access into the lobar branches, a 5-F, 125-cm vertebral catheter over a 0.035-inch stiff, angled Glidewire (Terumo Interventional Systems) was used. 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. 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. Do not use in oxygen rich environment. The Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. Prior to use, please refer to the . Figure 3. Do not use in an oxygen rich environment. No modification of this equipment is allowed. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Contraindications There are no known contraindications. Created with Sketch. 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. Now, the goal with thrombus removal in PE is to safely and effectively remove thrombus and potentially reduce treatment time. Real-world use of the Indigo System Lightning 7 and Lightning 12 Intelligent Aspiration in arterial, pulmonary embolism, and venous cases. Figure 5. Heart disease and stroke statistics2020 update: a report from the American Heart Association. right-arrow Icahn School of Medicine at Mount Sinai Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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 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.. Contraindications There are no contraindications. It will reduce the service life of the PENUMBRA ENGINE. Use prior to the Use By date. . Schwartz-Buckley Professor of Surgery, Vascular Division CAT3 advanced through the pedal loop (C). INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 Indication for Use As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. IVUS image showing May-Thurner narrowing of the left CIV and thrombus in the iliac vein. 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. Postprocedural CT of the patients left pulmonary anatomy. Do not resterilize or reuse. 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. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. Do not use open or damaged packages. A 47-year-old woman with no previous history of thromboembolism presented with sudden-onset PE. In addition, the RV/LV ratio decreased from 2.26 to 1.09, over a > 50% on-table decrease. Of note, the patient was not a good candidate for thrombolysis due to retroperitoneal hemorrhage from lymph node biopsy several days earlier. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Created with Sketch. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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. Low-dose tPA was dripped into the left and right lobes of the PA. The major adverse event rate in EXTRACT-PE was 1.7%, and patients had a median intensive care unit stay of < 1 day. Precautions The device is intended or single use only. February 2022. Betsy Merryman CAT12 features a large 0.131-inch lumen and angled tip for additional circumferential sweep (Figure 2). 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. Disclosures: None. Disclosures: Consultant to Penumbra, Inc. Do not use open or damaged packages. Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM Use prior to the Use By date. The primary outcome is the rate of TIMI 2-3 revascularization after treatment using the Indigo System. Miami Cancer Institute Do not block bottom air vents. betsy@merrymancommunications.com Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE . Equipment is not safe for MR use. When in free-flowing blood, this technology automatically stops aspirating blood and hence limits unnecessary loss of blood. Preprocedural CT of the patients left pulmonary anatomy. The Indigo System Lightning 12 was launched in July and is available immediately for patients needing interventional treatment for PE. The means of mains disconnect is to remove the power cord. 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. 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. NYU Langone Health PENUMBRA ENGINE Indication for Use Created with Sketch. However, these hybrid procedures include the invasiveness of open surgery and carry the risk of incomplete thrombus removal or vessel damage.1, Consequently, many new endovascular devices have been proposed to increase treatment success, decrease complications, and rapidly improve perfusion. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Access was gained using an 8-F sheath in the left popliteal vein, which was then upsized to a 12-F sheath. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. 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. This website is intended for US audience only. STRIDE is currently ongoing. Additional information about Penumbras products can be located on Penumbras website at http://www.penumbrainc.com/healthcare-professionals. Veryan Medical Will Support Commercialization of Walk Vasculars Jeti Thrombectomy System in Germany, left-arrow 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. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. The Indigo System of catheters are trackable, deliverable, and can provide a nice treatment option for complex patients. The Indigo System with . 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. Lightning was hooked up to the Indigo System Catheter CAT12 and placed into the access sheath. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Sista A. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. In PE cases, patients are often emergent and need interventions that provide immediate relief. Created with Sketch. Giri J, Sista A, Weinberg I, et al. The patients right leg was completely cold, insensate, and immobile from the thigh down. Semin Dial. 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. MHealth Fairview System Medical Director for Interventional Radiology Operations 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 system designed to reduce blood loss and the need for clot-dissolving drugs, which . investors@penumbrainc.com Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Do not use open or damaged packages. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. The clot detection algorithm paired with the audiovisual cues lets the physician know when the catheter is in thrombus versus when it is in blood. Executive Medical Director of Interventional Radiology & Vascular Imaging After adjunctive endovascular (angioplasty, stenting, or lysis), TIMI 2-3 was reached in up to 95.3% of patients. The catheter is robust and trackable, and the large lumen allows for thrombectomy either with a guidewire in place or without a guidewire. 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.

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