indigo system lightning 12
The INDIAN registry is a prospective, multicenter registry designed to investigate, in a controlled setting, the safety and initial efficacy of the Indigo System in the treatment of acute peripheral arterial thromboembolism. Lightning is paired with CAT8 or CAT12. 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 2. CAT12 features a large 0.131-inch lumen and angled tip for additional circumferential sweep (Figure 2). Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Copyright 2022 Penumbra, Inc. All rights reserved. CT revealed bilateral ALI (Figure 1). If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. The patients echocardiogram showed normal RV size and function. Indigo System | Penumbra Inc Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Miami Cardiac and Vascular Institute 510-995-2461 Do not re-infuse blood or fluid from the canister back into the patient. Carrera LA, Reddy R, Pamoukian VN, et al. Ask the Experts: How Do You Treat (and Avoid) Recurrent Varicose Veins? CT revealed that the patient had a bilateral PE with an elevated RV/LV ratio of 2.26, an elevated troponin level of 0.151 g/mL, and PA pressures at 35 mm Hg. 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. 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. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. (Photo: Business Wire). 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. INDIGO Aspiration System Indication for Use Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. A 48-year-old man presented with a 3-day history of acute shortness of breath and chest pressure. NYU Langone Health Venogram showing stents in the left CIV and EIV. Do not use in an oxygen rich environment. Penumbra gets expanded FDA approval for Lightning 12 aspiration system J Vasc Surg. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. Do not resterilize or reuse. 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. MHealth Fairview System Medical Director for Interventional Radiology Operations should be used no closer than 12 inches (30 cm) to any part of LIGHTNING Aspiration Tubing. 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.. Do not resterilize or reuse. Penumbra augments vascular franchise with latest Indigo System launch 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. 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.. 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. The patients right leg was completely cold, insensate, and immobile from the thigh down. Do not resterilize or reuse. Previous Article, Reversing the Death Spiral: FlowTriever Thrombectomy for High-Risk PE, With James Horowitz, MD, FACC; Mitchell J. Contraindications There are no contraindications. Return all damaged devices and packaging to the manufacturer/distributor. Giri J, Sista A, Weinberg I, et al. The wire was removed, and the CAT8 was used to remove thrombus from the popliteal artery. In PE cases, patients are often emergent and need interventions that provide immediate relief. Figure 1 shows a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism in the tibial and plantar arteries. 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. 2023 Bryn Mawr Communications II, LLC. Use prior to the Use By date. Venogram showing thrombosis of the left FV and CFV. The INDIGO SEPARATOR is not intended for use as a guidewire. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Rethinking Thrombus Removal With the Indigo System: Introducing New Indigo System By Penumbra - Medical Device News Magazine This procedure time has been embraced by countless interventionalists concerned about prolonged case times with other thromboaspiration technologies. The CAT familyof catheters is the foundation of Penumbras Indigo System. Do not use kinked or damaged devices. PENUMBRA ENGINE Indication for Use A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. o The Indigo catheters vary in diameters from 3.4Fr to 12Fr. Of note, the patient was not a good candidate for thrombolysis due to retroperitoneal hemorrhage from lymph node biopsy several days earlier. Bjrck M, Earnshaw JJ, Acosta S, et al. Ripal T. Gandhi, MD, FSIR, FSVM 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. Using the Lightning 12 and SEP12 (Penumbra, Inc.), we removed a huge clot from the iliac vein with a retrograde approach to the thrombus. Figure 6. No modification of this equipment is allowed. . 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. The device is intended for single use only. Return all damaged devices and packaging to the manufacturer/distributor. 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. 1. An intuitive clicking sound is made by the device that signals that one is in free-flowing blood. Disclosures: None. 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. CT showed a bilateral PE with right heart strain. Contraindications Not for use in the coronaries or the neurovasculature. A wire test was conducted in the right leg to determine the composition of the clot. Disclosures: None. Figure 7. The Indigo System aspiration catheter is available in a range of lengths and diameters that, when connected to the proprietary Penumbra Aspiration Pump, may help atraumatically remove the thrombus under continuous aspiration. Kingsport, Tennessee Las Vegas, Nevada Figure 3. Presented at Vascular InterVentional Advances (VIVA) 2019; November 6, 2019; Las Vegas, Nevada. The patient also had a history of bilateral PE dating back to October 2017, at which point rivaroxaban was prescribed. Indication For Use Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. J Vasc Interv Radiol. Aspiration may also be performed in conjunction with an Indigo System Separator (Penumbra, Inc.) to allow for constant clearing of thrombus from the lumen of the catheter. Associate Clinical Professor, University of South Florida College of Medicine 2. 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 Announces U.S. Commercial Availability of INDIGO System Precautions The device is intended for single use only. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change. Do not reuse. The patients left leg was cool to the touch with signs of paresthesia but with motor function still intact. 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Figure 1. Figure 3. Penumbra, a global healthcare company, has secured the expanded US Food and Drug Administration 510 (k) approval for the new generation of its Indigo Aspiration System, Lightning 12. Penumbra (PEN) Launches INDIGO System Lightning 7 in US - Yahoo Finance Do not use open or damaged packages. Utility of a power aspiration-based extraction technique as an initial and secondary approach in the treatment of peripheral arterial thromboembolism: results of the multicenter PRISM trial. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Immediately postprocedure, a decrease in PA pressure from 35 to 27 mm Hg was observed. PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW. doi: 10.1161/CIR.0000000000000707. Next Article When the catheter is engaged on thrombus or embolic material, the clicking sound ceases. Figure 3. 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. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Thrombotic disease puts patients at high risk of . 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Do not use kinked or damaged devices. Use only water-based solvents for cleaning. COURSE OF TREATMENT. INDIGO Aspiration System Indication for Use FDA Clears Penumbra's Lightning 12 Aspiration Catheter for Pulmonary 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. Made of laser-cut hypotube technology, the CAT12 is Penumbras most trackable and torqueable catheter to date. Eric Moldestad, MD 5. Use prior to the Use By date. 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. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo Professor, Cardiovascular Surgery Determining and Applying Appropriate Use of Venous Care, With Kathleen Ozsvath, MD, and Elna Masuda, MD, left-arrow Lightning 12. Do not use open or damaged packages. Do not use open or damaged packages. 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. Indigo System - Vascupedia 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. Precautions The device is intended or single use only. Upon arrival to the hospital, physical examination and a Doppler ultrasound examination revealed absent pulses in the left foot. Department of Diagnostic, Molecular, and Interventional Radiology Notably, Lightning 7 is designed . Now, the goal with thrombus removal in PE is to safely and effectively remove thrombus and potentially reduce treatment time. The Indigo System has been designed to address the limitations of traditional treatment options. PENUMBRA ENGINE Indication for Use Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. Single-session management of PE using the Indigo System CAT8 allows physicians to treat emergent patients. 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). Learn more about Lightning. Otherwise, this could result in degradation of the performance of this equipment. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. 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. Investor Relations: 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. Prior to use, please refer to the . Precautions The device is intended for single use only. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Department of Medicine, Surgery and Neuroscience Sanger Heart and Vascular Institute Plus, get our latest issues & supplements delivered to your inbox each month. Lightning was hooked up to the Indigo System Catheter CAT12 and placed into the access sheath. Dek Z, Strube H, Sadeghi-Azandaryani M, et al. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Precautions The device is intended or single use only. 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. Potential Adverse Events Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; 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; respiratory failure; peripheral thromboembolic events. Otherwise, this could result in degradation of the performance of this equipment. Lightning 12: 12 F (4.04 mm) HTORQ (100 cm, 115 cm lengths) XTORQ (100 cm length) Lightning 7: 7 F (2.3 mm) XTORQ (130 cm length) CAT . As presented on November 21, 2019, at VEITH 2019 by Dr. Gianmarco de Donato, University of Siena, Italy. LIGHTNING Aspiration Tubing Indication for Use Miami, Florida Otherwise, this could result in degradation of the performance of this equipment. The EXTRACT-PE study completed in 2019 evaluated the safety and efficacy of the Indigo Aspiration System in the management of submassive PE. The Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. 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. According to the American Heart Association, PE affects roughly 367,000 Americans per year.1. Executive Medical Director of Interventional Radiology & Vascular Imaging Sustained aspiration from the Indigo System provides physicians with an alternative option for patients who are not ideal candidates for lytics or open embolectomy and provides a frontline therapy option that still preserves the use of any adjunctive therapy. Fluoroscopy showed additional thrombus in the tibioperoneal trunk (TPT) (, Final fluoroscopy of the left leg showed restored distal runoff (. 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. 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. Figure 4. 2020;141(9):e139e596. The SEP12 was introduced to help clear the lumen of the catheter due to the heavy thrombus burden. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE.Shipwreck Chest Key Grantebridge, Types Of Vendors At Festivals, Articles I