We opted for aspiration thrombectomy with the Indigo System Lightning 12 with the 100-cm HTORQ tip (Penumbra, Inc.). 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. A wire test was conducted in the right leg to determine the composition of the clot. The 1:1 torqueability of the catheter was especially valuable for aspirating thrombus along the circumference of the larger-diameter iliac veins. Figure 3. Lightning 12 Intelligent Aspiration. 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. Figure 1. Of note, the patient was not a good candidate for thrombolysis due to retroperitoneal hemorrhage from lymph node biopsy several days earlier. 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. Otherwise, this could result in degradation of the performance of this equipment. Sanger Heart and Vascular Institute If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Warnings/Precautions The canister is intended for single use only. 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. Warnings/Precautions The canister is intended for single use only. Potential adverse . Penumbra's Newest Generation of Indigo Aspiration System Receives FDA 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. Lightning enables clot detection so the physician knows when the catheter is in thrombus and when it is in patent flow. Schwartz-Buckley Professor of Surgery, Vascular Division Prior to use, please refer to the . 2. Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. Cincinnati, Ohio All Rights Reserved Privacy Policy. The new Indigo System is engineered to allow for thrombectomy while helping to prevent excessive blood loss during the procedure. Disclosures: None. PENUMBRA ENGINE Indication for Use Lightning is paired with CAT8 or CAT12. 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. 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. The Indigo CAT8 XTORQ was advanced over the select catheter and used in both the right and left PAs. Precautions The device is intended or single use only. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. The results may not be predictive of all patients. We gained access through the right CFV using a 14-F sheath. New York, New York 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%. 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 open or damaged packages. Many of the first-generation mechanical endovascular devices for thrombus removal have failed to be adequately successful or have been associated with unacceptable complication rates. 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). Editors choiceEuropean Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the management of acute limb ischemia. 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. IVUS image showing May-Thurner narrowing of the left CIV and thrombus in the iliac vein. Ballad Health System CVA Heart & Vascular Institute Computer-Aided Thrombus Removal Using Penumbra's Lightning 7 and 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. Figure 2. Presented at Vascular InterVentional Advances (VIVA) 2019; November 6, 2019; Las Vegas, Nevada. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. Indication For Use In the current treatment of PE, standard treatments such as anticoagulation, thrombolysis, and open embolectomy have limitations. When in free-flowing blood, this technology automatically stops aspirating blood and hence limits unnecessary loss of blood. Do not use kinked or damaged devices. 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. Interventional Radiology If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Siena, Italy Image showing the total thrombus removed. 2020;141(9):e139e596. The system designed to reduce blood loss and the need for clot-dissolving drugs, which . Kingsport, Tennessee Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. The Indigo CAT12 Aspiration Catheter is indicated for removal of fresh, soft emboli and thrombi from vessels of the peripheral venous systems. Venogram showing stents in the left CIV and EIV. Betsy Merryman CT revealed an occlusion in the popliteal artery (Figure 1). Now, the goal with thrombus removal in PE is to safely and effectively remove thrombus and potentially reduce treatment time. 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. Penumbra has changed the landscape of healthcare by providing truly innovative solutions for a wide realm of medical challenges. Figure 3. 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. Chief, Vascular and Endovascular Surgery 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. After considering the acute onset of symptoms and the history of thrombosis, we decided to proceed with the Indigo System to treat the bilateral PE in one session. 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. New Indigo System By Penumbra - Medical Device News Magazine 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%. The Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. PENUMBRA ENGINE Indication for Use The CAT8s large lumen can allow for efficient clot removal, which can be enhanced when paired with mechanical separation from the SEP8. Maintain a constant infusion of appropriate flush solution. Executive Medical Director of Interventional Radiology & Vascular Imaging Return all damaged devices and packaging to the manufacturer/distributor. Associate Professor of Vascular Surgery Professor of Radiology and Surgery Lightning 7 a and Lightning 12 a are made of laser-cut hypotube technology, designed to increase trackability and torqueability. Penumbra (PEN) Launches INDIGO System Lightning 7 in US 1Virani, S.S. et al. Do not use open or damaged packages. 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. 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. Risk Information. The Indigo Aspiration System Lightning 12 granted FDA approval. The device is intended for single use only. right-arrow Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use. This website is intended for US audience only. Penumbra's Indigo Aspiration System Lightning 12 received FDA clearance for the treatment of pulmonary embolism. Lightning 12 with Intelligent Aspiration is a giant leap forward for the field of thrombectomy, and we have been very impressed with the early results at Sanger.. The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE (Figure 1). Contraindications Not for use in the coronaries or the neurovasculature. Do not block bottom air vents. The means of mains disconnect is to remove the power cord. Made of laser-cut hypotube technology, the CAT12 is Penumbras most trackable and torqueable catheter to date. Indigo System | Penumbra Inc This website is intended for US audience only. Do not resterilize or reuse. Precautions The device is intended or single use only. Thrombotic disease puts patients at high risk of . 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. 4. Figure 8. 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 Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE . The Indigo System Lightning 12 is the companys newest generation aspiration system for peripheral thrombectomy. Atrium Health Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Precautions The device is intended for single use only. 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. Merryman Communications Penumbra Augments Vascular Franchise with Latest Indigo System Launch CAT12 is a large . The thromboaspiration with the Indigo System was particularly useful in situations of multilevel vessel acute occlusion. Penumbra Announces U.S. Commercial Availability of INDIGO System Associate Professor of Radiology and 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. 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. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Penumbra augments vascular franchise with latest Indigo System launch Contraindications There are no known contraindications. Otherwise, this could result in degradation of the performance of this equipment. Giri J, Sista A, Weinberg I, et al. Figure 2. Do not re-infuse blood or fluid from the canister back into the patient. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 2018;29:92-100. doi: 10.1016/j.jvir.2017.08.019. 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 . Return all damaged devices and packaging to the manufacturer/distributor. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. 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 (.