indigo system lightning 12

2021 Nov 1;48(5):e217571. 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. Created with Sketch. 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. This website is intended for US audience only. Lightning was hooked up to the Indigo System Catheter CAT12 and placed into the access sheath. Do not use in oxygen rich environment. It will reduce the service life of the PENUMBRA ENGINE. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. 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 . Penumbra gets expanded FDA approval for Lightning 12 aspiration system Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Figure 1. Miami Cardiac and Vascular Institute 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. CAT7 and CAT12 are the next generation of the Indigo System Catheters. Traditionally, tPA or open embolectomy were the primary treatment options for acute-to-chronic lesions. 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 the PENUMBRA ENGINE. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. 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. STRIDE is currently ongoing. Las Vegas, Nevada Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 2023 Bryn Mawr Communications II, LLC. Computer-Aided Thrombus Removal Using Penumbra's Lightning 7 and Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. No modification of this equipment is allowed. The EXTRACT-PE study completed in 2019 evaluated the safety and efficacy of the Indigo Aspiration System in the management of submassive PE. Lightning 12 combines the Indigo System CAT12 aspiration catheter with lightning intelligent aspiration, enabling physicians to focus on optimising thrombus removal using the system's unique clot detection mechanism. Associate Clinical Professor, University of South Florida College of Medicine The CAT familyof catheters is the foundation of Penumbras Indigo System. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Contraindications There are no contraindications. In addition, the RV/LV ratio decreased from 2.26 to 1.09, over a > 50% on-table decrease. By capturing the clot without maceration and under high aspiration power, the risk for distal emboli may be minimized. Kingsport, Tennessee The Indigo Aspiration System provides a treatment option that is now cleared by the FDA to treat PE. 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 7 a and Lightning 12 a are made of laser-cut hypotube technology, designed to increase trackability and torqueability. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Warnings/Precautions The canister is intended for single use only. Otherwise, this could result in degradation of the performance of this equipment. However, it has also been associated with an unsatisfying revascularization rate due to the detection of residual thrombus in distal vessels. The latest generation of Penumbras continuous aspiration thrombectomy system features Indigo System Lightning 12 which combines the new Indigo System CAT 12 Aspiration Catheter with Lightning Intelligent Aspiration powered by Penumbra ENGINE, enabling physicians to focus on optimizing thrombus removal using the systems unique clot detection mechanism. Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with . 2023 Bryn Mawr Communications II, LLC. Disclosures: None. 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. Director of Interventional Radiology Executive Medical Director of Interventional Radiology & Vascular Imaging Use prior to the Use By date. Postprocedural CT of the patients left pulmonary anatomy. Do not use in an oxygen rich environment. Do not resterilize or reuse. rosen011@umn.edu INDIGO Aspiration System with LIGHTNING Aspiration Tubing - Indication for Use . Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. The INDIGO SEPARATOR is not intended for use as a guidewire. Do not use open or damaged packages. In such a case, the use of multiple catheters (CAT8 for popliteal, CAT6 for tibials, and CAT3 for plantars) was particularly helpful (Figure 2 and Figure 3). 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. Disclosures: Consultant to Penumbra, Inc. 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. Do not use kinked or damaged devices. 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. Do not resterilize or reuse. Precautions The device is intended for single use only. In summary, Lightning 12 is an excellent addition to the peripheral thrombectomy armamentarium and may allow for successful treatment of complex patients. 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 patients echocardiogram showed normal RV size and function. In PE cases, patients are often emergent and need interventions that provide immediate relief. Previous Article, Biotronik's Dynetic-35 Iliac Stent Launched in Europe. Do not use kinked or damaged devices. Maintain a constant infusion of appropriate flush solution. Penumbra Announces U.S. Commercial Availability of INDIGO System NYU Langone Health Figure 2. Continuous, sustained aspiration can effectively remove thrombus and potentially reduce the use of thrombolytics. MHealth Fairview System Medical Director for Interventional Radiology Operations Schwartz-Buckley Professor of Surgery, Vascular Division Silver, DO, FACC, FSVM, RPVI; Catalin Toma, MD; Pavan Khanna, MD; Mitchell Weinberg, MD; and Andrew Galmer, DO. 2013;26: E5-7. Professor of Radiology and Surgery 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. Scan showing preoperative left venous thrombus. 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. Plus, get our latest issues & supplements delivered to your inbox each month. Penumbra continues to strive to bring innovative therapies to the medical community, and this is another important milestone that will help advance pulmonary embolism intervention, said Adam Elsesser, president and chief executive officer, Penumbra. Penumbra Augments Vascular Franchise With Latest Indigo System Launch Maintain a constant infusion of appropriate flush solution. We gained access through the right CFV using a 14-F sheath. Stay informed on the week's top stories including literature summaries, device approvals, guideline changes, and more. University of Siena (Photo: Business Wire). February 2022. 1. The CAT8s large lumen can allow for efficient clot removal, which can be enhanced when paired with mechanical separation from the SEP8. Penumbra continues to lead the field of clot management by bringing highly innovative technology to address the challenges that we as physicians face while caring for our patients, commented Frank Arko, MD, in the company's announcement. 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. Throughout each case, Lightning provides procedural feedback via audiovisual cues. Contraindications There are no contraindications. 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. Gianmarco de Donato, MD Icahn School of Medicine at Mount Sinai 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. CT revealed bilateral ALI (Figure 1). Disclosures: None. Do not resterilize or reuse. To prevent fire or shock hazard, use a replacement power cord of equal rating. Semin Dial. Disclosures: None. 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.. Percutaneous manual thromboaspiration was the first technique proposed, followed by a series of percutaneous mechanical thrombectomy devices based on a different mechanism of action (mechanical fragmentation, aspiration, rheolytic thrombectomy, and their combinations). Figure 3. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Use prior to the Use By date. 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. Penumbra's Newest Generation of Indigo Aspiration System Receives FDA Otherwise, this could result in degradation of the performance of this equipment. The continuously powered engine pump , which is activated by a single touch, achieves a negative suction pressure of 29 inHg, a nearly pure vacuum. The device is intended for single use only. Do not resterilize or reuse. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 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. The means of mains disconnect is to remove the power cord. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. The Lightning 12 addition to the Indigo Aspiration System is a formative development in the thrombectomy space. 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 .

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