INDIGO Aspiration System with LIGHTNING Aspiration Tubing - Indication for Use . 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. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Figure 3. 2011;17:283-289. doi: 10.4261/1305-3825.DIR.3687-10.2, 3. Internet Explorer presents a security risk. Lightning Intelligent Aspiration comes packaged with the Indigo CAT 8 or the newest CAT12, the next generation of the Indigo System catheters. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Lightning 12. The Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. Figure 4. MHealth Fairview System Medical Director for Interventional Radiology Operations Diagn Interv Radiol. CT revealed an occlusion in the popliteal artery (Figure 1). 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. The Lightning 12 addition to the Indigo Aspiration System is a formative development in the thrombectomy space. When the catheter is engaged on thrombus or embolic material, the clicking sound ceases. Do not resterilize or reuse. 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. 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. 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 . Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Advancement of the CAT8 and CAT6 through the popliteal and tibial arteries (A, B). 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. 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. New York, New York The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. 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). Executive Medical Director of Interventional Radiology & Vascular Imaging The wire was removed, and the CAT8 was used to remove thrombus from the popliteal artery. 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. This website is intended for US audience only. STRIDE is currently ongoing. Potential adverse . Sista A. 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. Contraindications There are no contraindications. It will reduce the service life of the PENUMBRA ENGINE. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 2021 Nov 1;48(5):e217571. 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 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 was hooked up to the Indigo System Catheter CAT12 and placed into the access sheath. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Frank R. Arko III, MD 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 . 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. Use only water-based solvents for cleaning. investors@penumbrainc.com of Medicine Henderson Hospital 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. The CAT8s large lumen can allow for efficient clot removal, which can be enhanced when paired with mechanical separation from the SEP8. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Department of Diagnostic, Molecular, and Interventional Radiology When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Prior to use, please refer to the . Disclosures: None. The major adverse event rate in EXTRACT-PE was 1.7%, and patients had a median intensive care unit stay of < 1 day. The thromboaspiration with the Indigo System was particularly useful in situations of multilevel vessel acute occlusion. Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. In my radiology practice, Ive seen firsthand the challenges medical practitioners face while treating difficult medical conditions, stated Dr. Teigen in the announcement. Circulation. Blood clots in the lungs can block the lungs from absorbing oxygen, causing strain on the heart and other organs. Las Vegas, Nevada Contraindications There are no known contraindications. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. The patient, an active smoker, also had a history of pulmonary hypertension and hypercholesterolemia. Lightning enables clot detection so the physician knows when the catheter is in thrombus and when it is in patent flow. . Program Director, Vascular Fellowship & Integrated Residency 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. 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. Circulation. 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. Lightning 12 combines the Indigo System CAT12 Aspiration Catheter with . Created with Sketch. 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. Next Article Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. The Indigo System has been designed to address the limitations of traditional treatment options. Miami Cancer Institute A wire test was conducted in the right leg to determine the composition of the clot. Do not block bottom air vents. Figure 2. Do not use kinked or damaged devices. Return all damaged devices and packaging to the manufacturer/distributor. Single-session management of PE using the Indigo System CAT8 allows physicians to treat emergent patients. Contraindications There are no known contraindications. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. CAT 12 is a . The 1:1 torqueability of the catheter was especially valuable for aspirating thrombus along the circumference of the larger-diameter iliac veins. 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. Maintain a constant infusion of appropriate flush solution. Contraindications There are no contraindications. Figure 8. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo System and Lightning 12 Intelligent Aspiration Tex Heart Inst J. Return all damaged devices and packaging to the manufacturer/ distributor. 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. Created with Sketch. CT showed a bilateral PE with right heart strain. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. A 48-year-old man presented with a 3-day history of acute shortness of breath and chest pressure. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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. Atrium Health 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. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The patients right leg was completely cold, insensate, and immobile from the thigh down. LIGHTNING Aspiration Tubing Indication for Use Venogram showing stents in the left CIV and EIV. Disclosures: None. 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. Figure 1. Otherwise, this could result in degradation of the performance of this equipment. This procedure time has been embraced by countless interventionalists concerned about prolonged case times with other thromboaspiration technologies. 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. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. 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. 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. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Do not use open or damaged packages. Chief, Vascular and Endovascular Surgery Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Now, the goal with thrombus removal in PE is to safely and effectively remove thrombus and potentially reduce treatment time. Mean PA pressure postintervention was 21 mm Hg. Do not use open or damaged packages. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. The catheters, which were initially designed for intracranial navigation for the treatment of acute stroke, are provided with an atraumatic tip. Do not use kinked or damaged devices. The INDIGO SEPARATOR is not intended for use as a guidewire. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Mentors and Protgs: Conversations on Career and Craft With Alda L. Tam, MD, MBA, FRCPC, FSIR, FACR, The Patient Voice in Chronic Venous Disease Treatment: What We Have and Whats Coming Next, With Kathleen Gibson, MD, FACS, FAVLS, DABVLM; Al Compaan; and Manj Gohel, MBChB, MD, FRCS, FEBVS. J Vasc Surg. Traditionally, tPA or open embolectomy were the primary treatment options for acute-to-chronic lesions. Manhattan Veterans Administration Hospital 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. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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. 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. Use prior to the Use By date. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Embolization: Expanding Evidence and Awareness. 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. Created with Sketch. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use The Separator is specifically designed for mechanical clot engagement and is particularly helpful in acute-on-chronic thrombosis, in-stent/in-bypass fresh occlusion, and in below-the-knee (BTK) and all the way to the pedal arch thrombi localization (Figure 1). The Penumbra Indigo System Separator is intended for use with our Indigo System's CAT family of catheters to enable the removal of a wide range of thrombus. Do not re-infuse blood or fluid from the canister back into the patient. 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. (EXTRACT-PE). Of note, the patient was not a good candidate for thrombolysis due to retroperitoneal hemorrhage from lymph node biopsy several days earlier. The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE . 2018;29:92-100. doi: 10.1016/j.jvir.2017.08.019. Figure 5. The Indigo CAT12 Aspiration Catheter is indicated for removal of fresh, soft emboli and thrombi from vessels of the peripheral venous systems. 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. Author S Jay Mathews 1 Affiliation 1 Bradenton Cardiology Center, Manatee . 2019;140:e774-e801. 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. Risk Information. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Notably, Lightning 7 is designed . Precautions The device is intended for single use only. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. Disclosures: Consultant to Penumbra, Inc. Gianmarco de Donato, MD 5. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Created with Sketch. Maintain a constant infusion of appropriate flush solution. 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. Precautions The device is intended or single use only. 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. 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. Indication For Use Lightning is paired with CAT8 or CAT12. 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. 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 an oxygen rich environment. Dek Z, Strube H, Sadeghi-Azandaryani M, et al. Low-dose tPA was dripped into the left and right lobes of the PA. In summary, Lightning 12 is an excellent addition to the peripheral thrombectomy armamentarium and may allow for successful treatment of complex patients. 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. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. 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. rosen011@umn.edu IVUS image showing May-Thurner narrowing of the left CIV and thrombus in the iliac vein. Figure 6. The EXTRACT-PE trial demonstrated that the Indigo System can provide immediate mechanical relief using sustained aspiration. The INDIGO SEPARATOR is not intended for use as a guidewire. Restored distal flow to the left TPT. 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. Evaluating the safety and efficacy of the Indigo aspiration system in acute pulmonary embolism. New York, New York Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. The Indigo System Lightning 12 is the companys newest generation aspiration system for peripheral thrombectomy. It is low-profile and deliverable to all vascular territories in the pulmonary circulation. 310-560-8176. Postoperative angiogram showing 100% resolution of thrombus. Icahn School of Medicine at Mount Sinai 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. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. 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. Made of laser-cut hypotube technology, the CAT12 is Penumbras most trackable and torqueable catheter to date. Return all damaged devices and packaging to the manufacturer/distributor. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Mean PA pressure at the start of the case was 35 mm Hg. Postprocedural CT of the patients left pulmonary anatomy. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. February 2022. Scan showing preoperative left venous thrombus. 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. 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. 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. 1. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. 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. 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. This new thromboaspiration technology allows for clot removal and potential reduction in right heart and PA pressure. Do not use kinked or damaged devices. (Photo: Business Wire). Image of thrombus aspirated using the Indigo CAT12 Aspiration Catheter. COVID has increased the awareness of the need for therapies that remove blood clots, and we are thrilled with the FDA clearance of the PE treatment indication for Lightning 12..
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