The means of mains disconnect is to remove the power cord. Lightning 12. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. 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. 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 SEPARATOR is not intended for use as a guidewire. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW Chief of Vascular Surgery Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Venogram showing CAT12 in the CIV. Investor Relations: Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. 5. The means of mains disconnect is to remove the power cord. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Traditionally, tPA or open embolectomy were the primary treatment options for acute-to-chronic lesions. Use prior to the Use By date. Thrombotic disease puts patients at high risk of . Do not re-infuse blood or fluid from the canister back into the patient. This procedure time has been embraced by countless interventionalists concerned about prolonged case times with other thromboaspiration technologies. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. 2. CT revealed an occlusion in the popliteal artery (Figure 1). The reasons have been mainly related to the limited trackability, the risk of vessel injury, and/or the incidence of incomplete revascularization, and the risk of bleeding and hemolysis.2,3. The system designed to reduce blood loss and the need for clot-dissolving drugs, which . In addition, the RV/LV ratio decreased from 2.26 to 1.09, over a > 50% on-table decrease. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Created with Sketch. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Chief of Vascular Surgery The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. 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. Miami Cardiac and Vascular Institute Figure 2. Preprocedural CT of the patients left pulmonary anatomy. Potential adverse . 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. Postoperative angiogram showing 100% resolution of thrombus. CT revealed bilateral ALI (Figure 1). No modification of this equipment is allowed. Figure 1 shows a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism in the tibial and plantar arteries. To prevent fire or shock hazard, use a replacement power cord of equal rating. A 67-year-old woman with a history of venous thrombus and iliac venous stenting presented with significant recurrent left lower extremity venous thrombus, and the patients symptoms did not significantly improve with anticoagulation alone. Figure 2. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. No modification of this equipment is allowed. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. 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. Indication For Use 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. Patrick E. Muck, MD, RVT, FACS Do not use open or damaged packages. Dr. Arko is chief, Division of Vascular and Endovascular Surgery, Sanger Heart and Vascular Institute in Charlotte, North Carolina. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change. chronic clot, atherosclerotic plaque) The cerebral vasculature Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Do not resterilize or reuse. 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. 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 use open or damaged packages. Chief, Vascular and Endovascular Surgery The Indigo System has demonstrated high rates of revascularization with consistent success. Saxon RR, Benenati JF, Teigen C, et al. Penumbra Announces the European Launch of the Indigo System With IVUS image showing a widely patent lumen after thrombectomy and stenting. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Penumbra (PEN) Launches INDIGO System Lightning 7 in US Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM The patients right leg was completely cold, insensate, and immobile from the thigh down. Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use. 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. Throughout each case, Lightning provides procedural feedback via audiovisual cues. 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. of Medicine Return all damaged devices and packaging to the manufacturer/distributor. Lightning 12 and Separator 12 are designed for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Penumbra's Newest Generation of Indigo Aspiration System Receives FDA Access was gained through the groin using an 8-F Destination sheath (Terumo Interventional Systems). Minneapolis, Minnesota Do not resterilize or reuse. Do not use open or damaged packages. 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. 510-995-2461 Good Samaritan Hospital Maintain a constant infusion of appropriate flush solution. 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. 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. The thromboaspiration with the Indigo System was particularly useful in situations of multilevel vessel acute occlusion. Lightning was hooked up to the Indigo System Catheter CAT12 and placed into the access sheath. Image showing the total thrombus removed. Fluoroscopy showed additional thrombus in the tibioperoneal trunk (TPT) (, Final fluoroscopy of the left leg showed restored distal runoff (. 1. Do not use open or damaged packages. Maintain a constant infusion of appropriate flush solution. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Ballad Health System CVA Heart & Vascular Institute The acute pulmonary embolism (PE) treatment paradigm is evolving to treat patients that have emergent symptoms and are unable to tolerate long thromboaspiration procedures. Return all damaged devices and packaging to the manufacturer/distributor. Advancement of the CAT8 and CAT6 through the popliteal and tibial arteries (A, B). Do not use in an oxygen rich environment. Stainless steel hypotube; Large lumen size and circumferential sweep enables maximized thrombus engagement; Eur J Vasc Endovasc Surg. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Giri J, Sista A, Weinberg I, et al. Betsy Merryman Equipment is not safe for MR use. Image of thrombus aspirated using the Indigo CAT12 Aspiration Catheter. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. At Penumbra, I have a profound opportunity to change the course of healthcare delivery for people living with vascular disease. Warnings/Precautions The canister is intended for single use only. It will reduce the service life of the PENUMBRA ENGINE. Using the Lightning 12 and SEP12 (Penumbra, Inc.), we removed a huge clot from the iliac vein with a retrograde approach to the thrombus. Circulation. The on-table PA pressures were statistically reduced, and the median device time was 37 minutes. Industry Prospects 2020;141(9):e139e596. Penumbra Augments Vascular Franchise With Latest Indigo System Launch Ripal T. Gandhi, MD, FSIR, FSVM Co-Director, Aortic Institute 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). Created with Sketch. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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 SEP12 was introduced to help clear the lumen of the catheter due to the heavy thrombus burden. Miami Vascular Specialists Of note, the patient was not a good candidate for thrombolysis due to retroperitoneal hemorrhage from lymph node biopsy several days earlier. Siena, Italy Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 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. 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. Penumbra Announces the European Launch of the Indigo System With 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. 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 fundamental components of the Lightning 12 Intelligent Aspiration system are the Engine pump, the Lightning control unit, and the CAT 12 HTORQ 12F catheter. investors@penumbrainc.com

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