indigo system lightning 12

Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. With the severity of this patients symptoms, immediate relief was required to maintain limb viability and the different profiles of the Indigo catheters provided a complete portfolio for aspiration in the arterial vasculature, starting with the CAT8 in the SFA and BTK to using the CAT RX coaxially in the heavily diseased TPT. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Desert Radiology Lightning has also demonstrated an 18:1 potential fluid loss savings during bench top testing when used versus the Dynamic Aspiration Tubing. Although motor function was still intact, there was decreased sensation and delayed capillary refill in the left foot and calf. 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. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. Do not use open or damaged packages. Poor distal runoff from acute thrombus. 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. The Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. 310-560-8176. New York, New York In the current treatment of PE, standard treatments such as anticoagulation, thrombolysis, and open embolectomy have limitations. Scan showing preoperative left venous thrombus. 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. Single-session management of PE using the Indigo System CAT8 allows physicians to treat emergent patients. Embolization: Expanding Evidence and Awareness. Mean PA pressure postintervention was 21 mm Hg. 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. 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. 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.. Diagn Interv Radiol. Manhattan Veterans Administration Hospital The patient, an active smoker, also had a history of pulmonary hypertension and hypercholesterolemia. Do not use kinked or damaged devices. The catheters, which were initially designed for intracranial navigation for the treatment of acute stroke, are provided with an atraumatic tip. Figure 6. Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM Otherwise, this could result in degradation of the performance of this equipment. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. 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. 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. Preprocedural CT of the patients left pulmonary anatomy. The EXTRACT-PE study completed in 2019 evaluated the safety and efficacy of the Indigo Aspiration System in the management of submassive PE. Disclosures: Consultant to Penumbra, Inc. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. Figure 2. Media Relations: 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. Do not use in an oxygen rich environment. This site is protected by reCAPTCHA and the Google, Mechanical clot engagement with proprietary Separator technology, Tip directionality for circumferential aspiration, The Indigo System is an integrated system for use only with other components of the Indigo System including the CAT family of catheters, Separators, Dynamic Aspiration Tubing, Lightning, Penumbra ENGINE, and Penumbra ENGINE Canister, Lightning Intelligent Aspiration comes packaged with CAT7, CAT8 or CAT12, Live feedback during the procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister. Blood clots in the lungs can block the lungs from absorbing oxygen, causing strain on the heart and other organs. Created with Sketch. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change. Figure 2. Access was gained using an 8-F sheath in the left popliteal vein, which was then upsized to a 12-F sheath. 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. We performed a transjugular access with a 12-F introducer sheath. The new Indigo System is engineered to allow for thrombectomy while helping to prevent excessive blood loss during the procedure. Figure 1. With Ramona Gupta, MD, FSIR; Suman M. Wasan, MD, MS, FSVM; and Avianne Bunnell, MD, RPVI, By Andres Schanzer, MD, FACS, and Stphan Haulon, MD, PhD, By Dominique Fabre, MD, PhD; Thomas J. Postiglione, MD; and Stphan Haulon, MD, PhD, Unmet Needs in Ascending and Arch Disease, With Tilo Klbel, MD, PhD, and Joseph Bavaria, MD, With Giovanni Pratesi, MD; Martina Bastianon, MD; Sara Di Gregorio, MD; Gaddiel Mozzetta, MD; and Kimberly Malka, MD, PhD, With Tim Resch, MD, PhD; Sara L. Zettervall, MD, MPH; and Carlos Timaran, MD. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Maintain a constant infusion of appropriate flush solution. on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. This combination of intelligent aspiration and large-lumen catheter engineering makes Lightning 12 Penumbras most advanced clot removal technology for the treatment of pulmonary embolism. . Catheters & Separators. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 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 Indigo Aspiration System Lightning 12 granted FDA approval. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Equipment is not safe for MR use. Copyright 2022 Penumbra, Inc. All rights reserved. Do not use open or damaged packages. Good Samaritan Hospital Lightning 12 combines the Indigo System CAT12 Aspiration Catheter with . A 47-year-old woman with no previous history of thromboembolism presented with sudden-onset PE. 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. Such results give more evidence for a shift of treatment recommendation toward endovascular options in the patients with ALI, as already suggested by the recent European Society of Cardiology/European Society for Vascular Surgery guidelines. A 0.014-inch wire was used to track to the occlusion, and the Indigo System CAT6 was used to aspirate the clot (. 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. 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. Precautions The device is intended for single use only. Figure 3. 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. 2018;29:92-100. doi: 10.1016/j.jvir.2017.08.019. Circulation. 2021 Nov 1;48(5):e217571. 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. Associate Clinical Professor, University of South Florida College of Medicine The patient also had a history of bilateral PE dating back to October 2017, at which point rivaroxaban was prescribed. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Figure 1. Equipment is not safe for MR use. Author S Jay Mathews 1 Affiliation 1 Bradenton Cardiology Center, Manatee . Atrium Health 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. The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum (-29 inHg or 98.2 kPa) to our catheters, enabling thrombus removal in vessels of various sizes. 1Virani, S.S. et al. 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. The INDIGO SEPARATOR is not intended for use as a guidewire. Veryan Medical Will Support Commercialization of Walk Vasculars Jeti Thrombectomy System in Germany, left-arrow STRIDE is the newest study from Penumbra evaluating the removal of thrombus with the Indigo Aspiration System in patients with lower extremity ALI. Venogram showing stents in the left CIV and EIV. Evaluating the safety and efficacy of the Indigo aspiration system in acute pulmonary embolism. Created with Sketch. Figure 3. Vessel patency is assessed using the thrombolysis in myocardial infarction (TIMI) score classifications, both before and after the use of 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).

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