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. Created with Sketch. 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. Cincinnati, Ohio In my radiology practice, Ive seen firsthand the challenges medical practitioners face while treating difficult medical conditions, stated Dr. Teigen in the announcement. (Photo: Business Wire). Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Evaluating the safety and efficacy of the Indigo aspiration system in acute pulmonary embolism. 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. Do not resterilize or reuse. Return all damaged devices and packaging to the manufacturer/distributor. Do not block bottom air vents. Contraindications Not for use in the coronaries or the neurovasculature. 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 block bottom air vents. doi: 10.1161/CIR.0000000000000707. The INDIGO SEPARATOR is not intended for use as a guidewire. Lightning Intelligent Aspiration allows physicians to optimize the thrombus removal needed to complete venous thrombus procedures that would otherwise be more complicated. Penumbra, the Penumbra P logo, Indigo, CAT, Separator, Lightning, and Penumbra ENGINE are trademarks of Penumbra, Inc. For more information, visit www.penumbrainc.com and connect on Twitter and LinkedIn. INDIGO Aspiration System Indication for Use Venogram showing thrombosis of the left FV and CFV. In PE cases, patients are often emergent and need interventions that provide immediate relief. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Do not use kinked or damaged devices. The wire test was done once again in the left leg, showing poor flow, a BTK clot, and evidence of chronicity. Disclosures: None. Do not use open or damaged packages. Use prior to the Use By date. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Gianmarco de Donato, MD Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. Next Article The patient had a history of lower left extremity venous thrombus dating back to 2013, with chronic residual nonocclusive popliteal vein thrombus in 2018. 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. Device Problem Adverse Event Without Identified Device or Use Problem (2993) The product was not returned for evaluation. A 0.014-inch wire was used to track to the occlusion, and the Indigo System CAT6 was used to aspirate the clot (. Do not re-infuse blood or fluid from the canister back into the patient. The Indigo System Lightning 12 was launched in July and is available immediately for patients needing interventional treatment for PE. Risk Information. When 4 solid illuminated bars on the . Return all damaged devices and packaging to the manufacturer/distributor. Do not resterilize or reuse. 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; arteriovenous fistula; cardiac injury; cardio-respiratory arrest; death; device malfunction; distal embolization; emboli; excessive blood loss; 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; hemoptysis; respiratory failure; thromboembolic events. The EXTRACT-PE study completed in 2019 evaluated the safety and efficacy of the Indigo Aspiration System in the management of submassive PE. Do not use kinked or damaged devices. Factors that could cause actual results to differ from those projected include, but are not limited to: the impact of the COVID-19 pandemic on our business, results of operations and financial condition; failure to sustain or grow profitability or generate positive cash flows; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base, expand our user base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; permanent write-downs or write-offs of our inventory; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; and potential adverse regulatory actions. 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. Access was gained using an 8-F sheath in the left popliteal vein, which was then upsized to a 12-F sheath. Icahn School of Medicine at Mount Sinai Intraoperative angiography can identify any arterial imperfection after surgical thromboembolectomy, which may be corrected simultaneously by endovascular techniques. Created with Sketch. Only use replacement fuse with correct rating (see Table 1 for fuse rating). To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 2011;17:283-289. doi: 10.4261/1305-3825.DIR.3687-10.2, 3. The patient also had a history of bilateral PE dating back to October 2017, at which point rivaroxaban was prescribed. Created with Sketch. The acute pulmonary embolism (PE) treatment paradigm is evolving to treat patients that have emergent symptoms and are unable to tolerate long thromboaspiration procedures. 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. Figure 8. Potential adverse . 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%. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The patients right leg was completely cold, insensate, and immobile from the thigh down. 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. 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 . 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. Do not resterilize or reuse. The device is intended for single use only. 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. doi: 10.14503/THIJ-21-7571. 2020;59:173-218. doi: 10.1016/j.ejvs.2019.09.006. Do not use kinked or damaged devices. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Thomas S. Maldonado, MD Traditionally, tPA or open embolectomy were the primary treatment options for acute-to-chronic lesions. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. 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. 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). 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. Immediately after, Lightning with the Indigo System Catheter CAT8 was used to aspirate thrombus in the left PA (, Due to increased amounts of thrombus in the right lobe, the SEP8 was introduced to clear the lumen of the catheter (. Otherwise, this could result in degradation of the performance of this equipment. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo System and Lightning 12 Intelligent Aspiration Tex Heart Inst J. Giri J, Sista A, Weinberg I, et al. Disclosures: Consultant to Penumbra, Inc. A 68-year-old man presented with a sudden coolness in both legs after stopping apixaban therapy for 3 days. o The Indigo catheters vary in diameters from 3.4Fr to 12Fr. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Precautions The device is intended for single use only. This website is intended for US audience only. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. The audiovisual cues from Lightning and the thrombus detection algorithm enabled us to navigate the lobar branches of the PA. Lightnings audio cues, in the form of clicking, help with clot detection to optimize thrombus removal and focus on the screen rather than monitor flow through the tubing and canister. Warnings/Precautions The canister is intended for single use only. Chief of Vascular Surgery Disclosures: None. With Lightning 8, we were able to clear the loft lobar branch and detect that we had established substantial inflow and outflow so we could move to the next affected lobe. Patrick E. Muck, MD, RVT, FACS Miami, Florida 2023 Bryn Mawr Communications II, LLC. 1. Vessel patency is assessed using the thrombolysis in myocardial infarction (TIMI) score classifications, both before and after the use of the device. Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with . Author S Jay Mathews 1 Affiliation 1 Bradenton Cardiology Center, Manatee . Angiography showed the presence of a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism tibial (A) and plantar arteries (B). Program Director, Vascular Fellowship & Integrated Residency Semin Dial. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. The on-table PA pressures were statistically reduced, and the median device time was 37 minutes. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Lightning is paired with CAT8 or CAT12. Do not use in an oxygen rich environment. 1. Figure 2. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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 combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. The CAT8s large lumen can allow for efficient clot removal, which can be enhanced when paired with mechanical separation from the SEP8. J Vasc Surg. 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. Do not resterilize or reuse. 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. 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. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. This website is intended for US audience only. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Figure 3. 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). J Vasc Interv Radiol. Using the HTORQ angle on CAT12 to torque the catheter, several passes were made through the affected area, from the left popliteal to the external iliac vein (EIV) and internal iliac vein. investors@penumbrainc.com Otherwise, this could result in degradation of the performance of this equipment. New York, New York Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Poor flow through the left TPT. Penumbra, Inc. Heart disease and stroke statistics2020 update: a report from the American Heart Association. If the cause cannot be determined, withdraw the device or system as a unit. Atrium Health Use prior to the Use By date. Of note, the patient was not a good candidate for thrombolysis due to retroperitoneal hemorrhage from lymph node biopsy several days earlier. 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. Scan showing preoperative left venous thrombus. 510-995-2461 Use prior to the Use By date. Created with Sketch. Dek Z, Strube H, Sadeghi-Azandaryani M, et al. CAT 12 is a . 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. 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. 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 . Copyright 2022 Penumbra, Inc. All rights reserved. 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. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. 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 . Desert Radiology This procedure time has been embraced by countless interventionalists concerned about prolonged case times with other thromboaspiration technologies. 1. If the cause cannot be determined, withdraw the device or system as a unit. CAT12 is a large . Equipment is not safe for MR use. Precautions The device is intended for single use only. STRIDE is currently ongoing. However, it has also been associated with an unsatisfying revascularization rate due to the detection of residual thrombus in distal vessels. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. The Indigo System Lightning 12 is the companys newest generation aspiration system for peripheral thrombectomy. (Credit: Business Wire.) Single-session management of PE using the Indigo System CAT8 allows physicians to treat emergent patients. Saxon RR, Benenati JF, Teigen C, et al. 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. Now, the goal with thrombus removal in PE is to safely and effectively remove thrombus and potentially reduce treatment time. 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. ALAMEDA, Calif.--(BUSINESS WIRE)--Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the latest iteration of the Indigo Aspiration System, Lightning 12. Return all damaged devices and packaging to the manufacturer/ distributor. 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. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Access was gained through the groin using an 8-F Destination sheath (Terumo Interventional Systems). 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. Created with Sketch. Siena, Italy The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. MHealth Fairview System Medical Director for Interventional Radiology Operations Do not use open or damaged packages. Precautions The device is intended or single use only. Disclosures: None. Do not use open or damaged packages. Blood clots in the lungs can block the lungs from absorbing oxygen, causing strain on the heart and other organs. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. At the 30-day follow-up, the patient no longer had residual shortness of breath or exertional dyspnea. 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. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Miami Cancer Institute Lightning Intelligent Aspiration comes packaged with the Indigo CAT 8 or the newest CAT12, the next generation of the Indigo System catheters. Penumbra's Indigo Aspiration System Lightning 12 received FDA clearance for the treatment of pulmonary embolism. 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. Previous Article, Reversing the Death Spiral: FlowTriever Thrombectomy for High-Risk PE, With James Horowitz, MD, FACC; Mitchell J. NYU Langone Health Frank R. Arko III, MD Scans revealed a left lower extremity venous thrombus extending from the calf to the common iliac vein (CIV) (Figure 1). Prior to use, please refer to the . Chief of Vascular Surgery The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. 4 min read. 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. It is a welcome addition to our existing endovascular technologies for the treatment of acute PE. Do not use in an oxygen rich environment. Use prior to the Use By date. The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE . Do not resterilize or reuse. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Figure 3. Figure 1 shows a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism in the tibial and plantar arteries. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. 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. 2021 Nov 1;48(5):e217571. Enter your email address and we will contact you. 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. Use prior to the Use By date. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Do not use kinked or damaged devices. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. Lightning enables clot detection so the physician knows when . The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Associate Professor of Vascular Surgery Venogram showing CAT12 in the CIV. Maintain a constant infusion of appropriate flush solution. Created with Sketch. It will reduce the service life of the PENUMBRA ENGINE. Dr. Arko is chief, Division of Vascular and Endovascular Surgery, Sanger Heart and Vascular Institute in Charlotte, North Carolina. Co-Director, Aortic Institute Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. right-arrow We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change. 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. 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.. Previous Article, Biotronik's Dynetic-35 Iliac Stent Launched in Europe. 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. Although motor function was still intact, there was decreased sensation and delayed capillary refill in the left foot and calf. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Carrera LA, Reddy R, Pamoukian VN, et al. 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. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. This combination of intelligent aspiration and large-lumen catheter engineering forms Lightning 12: the latest generation in clot removal technology. Ripal T. Gandhi, MD, FSIR, FSVM Otherwise, this could result in degradation of the performance of this equipment. The PRISM trial, a retrospective case analysis assessing the rate of TIMI 2-3 flow after the use of Indigo and specifically the XTRACT technique, showed an 87.2% rate of revascularization post-Indigo and subsequent treatment of underlying stenosis in the same setting.1 The newly completed study studying the same primary outcome as PRISM, the INDIAN registry, showed an even higher rate of revascularization, 88.7%.2 Sustained aspiration for ALI could potentially increase the revascularization rate by serving as an effective single-session frontline option. 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. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. 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. Good Samaritan Hospital Do not use in oxygen rich environment. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Do not use in oxygen rich environment. Bjrck M, Earnshaw JJ, Acosta S, et al. The EXTRACT-PE trial demonstrated that the Indigo System can provide immediate mechanical relief using sustained aspiration. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. In the current treatment of PE, standard treatments such as anticoagulation, thrombolysis, and open embolectomy have limitations. Figure 7. chronic clot, atherosclerotic plaque) The cerebral vasculature Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. Contraindications There are no known contraindications. Figure 1. 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. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. We opted for aspiration thrombectomy with the Indigo System Lightning 12 with the 100-cm HTORQ tip (Penumbra, Inc.). 1. de Donato G, Setacci F, Sirignano P, Galzerano G, Massaroni R, Setacci C. The combination of surgical embolectomy and endovascular techniques may improve outcomes of patients with acute lower limb ischemia. 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.
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