indigo system lightning 12

Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Maintain a constant infusion of appropriate flush solution. Figure 3. Penumbra Indigo System | Vascular Thrombectomy Charlotte, North Carolina 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. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. CT showed a bilateral PE with right heart strain. 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. Ripal T. Gandhi, MD, FSIR, FSVM We gained access through the right CFV using a 14-F sheath. 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.. Return all damaged devices and packaging to the manufacturer/distributor. 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. However, it has also been associated with an unsatisfying revascularization rate due to the detection of residual thrombus in distal vessels. 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. INDIGO SEPARATOR 4 is intended to be used with INDIGO CAT RX Aspiration Catheter to clear the distal end of the catheter lumen should it be blocked with thrombus. 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. FDA Clears Penumbra's Lightning 12 Aspiration Catheter for Pulmonary Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo Do not use kinked or damaged devices. 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. 2020;59:173-218. doi: 10.1016/j.ejvs.2019.09.006. 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. (EXTRACT-PE). By capturing the clot without maceration and under high aspiration power, the risk for distal emboli may be minimized. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Giri J, Sista A, Weinberg I, et al. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW 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. Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. Rethinking Thrombus Removal With the Indigo System: Introducing According to the American Heart Association, PE affects roughly 367,000 Americans per year.1. Bjrck M, Earnshaw JJ, Acosta S, et al. STRIDE is currently ongoing. Do not block bottom air vents. Do not use open or damaged packages. Earlier in November 2020, Penumbra announced the receipt of 510(k) FDA clearance for an expanded indication of the latest iteration of the Indigo Aspiration System, Lightning 12. Figure 2. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. . Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. A 47-year-old woman with no previous history of thromboembolism presented with sudden-onset PE. Figure 1. Restored distal flow to the left TPT. Penumbra has changed the landscape of healthcare by providing truly innovative solutions for a wide realm of medical challenges. 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. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Intraoperative angiography can identify any arterial imperfection after surgical thromboembolectomy, which may be corrected simultaneously by endovascular techniques. 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. 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. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Poor flow through the left TPT. Preliminary data from the INDIAN registry is promising regarding early safety and efficacy for the revascularization of acute peripheral arterial occlusions with thromboaspiration as primary therapy. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Department of Diagnostic, Molecular, and Interventional Radiology Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use INDIGO Aspiration System with LIGHTNING Aspiration Tubing - Indication for Use . 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. Executive Vice Chairman Venogram showing CAT12 in the CIV. 2013;26: E5-7. 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. 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. Penumbra augments vascular franchise with latest Indigo System launch I feel privileged to join Penumbras unparalleled group of talented engineers and leaders, and I look forward to contributing my scientific knowledge to help solve challenging medical problems., Dr. Benenati commented, Im excited to join Penumbra at this very important time for the company, where its poised for growth, as it moves into the next generation of intelligent clot removal and expand into rehabilitation with the recent launch of the Real system. Figure 5. Do not resterilize or reuse. Penumbra gets expanded FDA approval for Lightning 12 aspiration system Miami Cancer Institute (Photo: Business Wire). 5. Penumbra Augments Vascular Franchise With Latest Indigo System Launch betsy@merrymancommunications.com Contraindications There are no known contraindications. 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. Atrium Health Stay informed on the week's top stories including literature summaries, device approvals, guideline changes, and more. Use prior to the Use By date. Fluoroscopy showed additional thrombus in the tibioperoneal trunk (TPT) (, Final fluoroscopy of the left leg showed restored distal runoff (. Indigo System | Penumbra Inc No modification of this equipment is allowed. This website is intended for US audience only. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Mentors and Protgs: Conversations on Career and Craft With Alda L. Tam, MD, MBA, FRCPC, FSIR, FACR, The Patient Voice in Chronic Venous Disease Treatment: What We Have and Whats Coming Next, With Kathleen Gibson, MD, FACS, FAVLS, DABVLM; Al Compaan; and Manj Gohel, MBChB, MD, FRCS, FEBVS. Equipment is not safe for MR use. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. This combination of intelligent aspiration and large-lumen catheter engineering forms Lightning 12: the latest generation in clot removal technology. Figure 1. Icahn School of Medicine at Mount Sinai With the maximized inner diameter of 0.082 and a 7 French outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 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. The latest addition to the catheter line, the CAT12, is Penumbras most torqueable and trackable catheter to date. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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. Created with Sketch. 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.. Author S Jay Mathews 1 Affiliation 1 Bradenton Cardiology Center, Manatee . 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. 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. PENUMBRA ENGINE Indication for Use 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. 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. Created with Sketch. Copyright 2022 Penumbra, Inc. All rights reserved. Use only water-based solvents for cleaning. Otherwise, this could result in degradation of the performance of this equipment. 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. 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. Lightning was hooked up to the Indigo System Catheter CAT12 and placed into the access sheath. The sustained aspiration from the Penumbra ENGINE provides constant uninterrupted full-vacuum aspiration throughout the procedure, addressing the constraints of syringe-based large-bore embolectomy, which include vacuum dropoff from the syringe filling with fluid. 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. Precautions The device is intended or single use only. Diagn Interv Radiol. Contraindications There are no known contraindications. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Massive intravascular hemolysis with mechanical rheolytic thrombectomy of a hemodialysis arteriovenous fistula. Lightning enables clot detection so the physician knows when . Created with Sketch. Penumbra's Indigo Aspiration System Lightning 12 received FDA clearance for the treatment of pulmonary embolism. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. A wire test was conducted in the right leg to determine the composition of the clot. Do not use kinked or damaged devices. For bilateral occlusions where thrombus is laced throughout the SFA in both legs and with potential for acute-to-chronic occlusion distally, the Indigo System provides a frontline treatment option that potentially preserves limb viability. 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. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Las Vegas, Nevada To prevent fire or shock hazard, use a replacement power cord of equal rating. Dek Z, Strube H, Sadeghi-Azandaryani M, et al. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. The Indigo CAT12 represents an advancement in mechanical thrombectomy given its ability to aspirate large-volume thrombus in a single-session setting, which is especially beneficial in larger-lumen vascular beds, such as large-caliber veins as demonstrated in this case. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Notably, Lightning 7 is designed . Sponsored by Penumbra, Inc. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Intelligent Aspiration. We opted for aspiration thrombectomy with the Indigo System Lightning 12 with the 100-cm HTORQ tip (Penumbra, Inc.). LIGHTNING Aspiration Tubing Indication for Use Lightning Intelligent Aspiration comes packaged with the Indigo CAT 8 or the newest CAT12, the next generation of the Indigo System catheters. CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to . An intuitive clicking sound is made by the device that signals that one is in free-flowing blood. July 14, 2020P enumbra, Inc. announced the United States commercial availability of the Indigo System Lightning 12, which is the company's next-generation aspiration system for peripheral thrombectomy.. 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Figure 3. CT revealed an occlusion in the popliteal artery (Figure 1). The patient, an active smoker, also had a history of pulmonary hypertension and hypercholesterolemia. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Only use replacement fuse with correct rating (see Table 1 for fuse rating). 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. Access was gained through the groin using an 8-F Destination sheath (Terumo Interventional Systems). 2. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. No modification of this equipment is allowed. Device Problem Adverse Event Without Identified Device or Use Problem (2993) The product was not returned for evaluation. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. 2014;59:729-36. The INDIGO SEPARATOR is not intended for use as a guidewire. 1Virani, S.S. et al. Do not use in oxygen rich environment. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. As presented on November 21, 2019, at VEITH 2019 by Dr. Gianmarco de Donato, University of Siena, Italy. Use prior to the Use By date. Do not resterilize or reuse. Traditionally, tPA or open embolectomy were the primary treatment options for acute-to-chronic lesions. 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. 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. Created with Sketch. Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with . Chief, Vascular and Endovascular Surgery Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Created with Sketch. (Credit: Business Wire.) Lightning 12 and Lightning 8 expand the already broad offering of CAT8, CATD, CAT6, CAT5, and CAT3 and are paired with Penumbra ENGINE, the companys proprietary continuous, mechanical vacuum aspiration pump. The system designed to reduce blood loss and the need for clot-dissolving drugs, which . Use prior to the Use By date. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM 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. 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. 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. on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Contraindications Not for use in the coronaries or the neurovasculature. Penumbra's Newest Generation of Indigo Aspiration System Receives FDA If the cause cannot be determined, withdraw the device or system as a unit. There was poor distal runoff after wire crossing, indicating acute thrombus (, The Indigo System Catheter CAT8 was used in the superficial femoral artery (SFA) with several passes until flow was restored and the patient could move and feel his leg again (. The Lightning 12 addition to the Indigo Aspiration System is a formative development in the thrombectomy space. Do not use in an oxygen rich environment. CAT7 and CAT12 are the next generation of the Indigo System Catheters. The acute pulmonary embolism (PE) treatment paradigm is evolving to treat patients that have emergent symptoms and are unable to tolerate long thromboaspiration procedures. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. 2023 Bryn Mawr Communications II, LLC. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. CAT 12 is a . Thrombotic disease puts patients at high risk of . Industry Prospects This website is intended for US audience only. Lightning 12 combines the Indigo System CAT 12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Angiography showed the presence of a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism tibial (A) and plantar arteries (B). Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. 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. New York University Langone Medical Center The on-table PA pressures were statistically reduced, and the median device time was 37 minutes. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Postoperative angiogram showing 100% resolution of thrombus. 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.
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