indigo system lightning 12

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. Created with Sketch. 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. Blood clots in the lungs can block the lungs from absorbing oxygen, causing strain on the heart and other organs. Warnings/Precautions The canister is intended for single use only. Computer-Aided Thrombus Removal Using Penumbra's Lightning 7 and Copyright 2022 Penumbra, Inc. All rights reserved. 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. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. 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. Copyright 2022 Penumbra, Inc. All rights reserved. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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 patient, an active smoker, also had a history of pulmonary hypertension and hypercholesterolemia. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. 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. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. 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). D. Chris Metzger, MD 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. July 14, 2020Penumbra, Inc. announced the United States commercial availability of the Indigo System Lightning 12, which is the companys next-generation aspiration system for peripheral thrombectomy. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Author S Jay Mathews 1 Affiliation 1 Bradenton Cardiology Center, Manatee . When the catheter is engaged on thrombus or embolic material, the clicking sound ceases. 2014;59:729-36. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Contraindications Not for use in the coronaries or the neurovasculature. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Contraindications There are no contraindications. 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 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. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. 2023 Bryn Mawr Communications II, LLC. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Penumbra Announces U.S. Commercial Availability of INDIGO System LIGHTNING Aspiration Tubing Indication for Use Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Precautions The device is intended for single use only. CT revealed bilateral ALI (Figure 1). Catheters & Separators. 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. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW 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. investors@penumbrainc.com Las Vegas, Nevada Thomas S. Maldonado, MD 4. Sanger Heart and Vascular Institute Presented at Vascular InterVentional Advances (VIVA) 2019; November 6, 2019; Las Vegas, Nevada. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Lightning Intelligent Aspiration allows physicians to optimize the thrombus removal needed to complete venous thrombus procedures that would otherwise be more complicated. The CAT8s large lumen can allow for efficient clot removal, which can be enhanced when paired with mechanical separation from the SEP8. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Industry Prospects To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. The Penumbra Indigo System Separator is intended for use with our Indigo Systems CAT family of catheters to enable the removal of a wide range of thrombus. Use only water-based solvents for cleaning. Editors choiceEuropean Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the management of acute limb ischemia. 310-560-8176. The decision was made to proceed with mechanical thrombectomy. Use prior to the Use By date. University of Siena 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 Aspiration Catheters to the Penumbra Aspiration Pump. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on February 26, 2020, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 filed with the SEC on May 7, 2020, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 filed with the SEC on August 3, 2020, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 filed with the SEC on November 2, 2020. Do not block bottom air vents. Dr. Benenati will join Penumbra on September 1, 2020, and will contribute to clinical and medical affairs strategies and advise upon global commercialization and market development activities. The catheter is robust and trackable, and the large lumen allows for thrombectomy either with a guidewire in place or without a guidewire. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. 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. New Indigo System By Penumbra - Medical Device News Magazine If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Figure 4. 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. 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. Do not re-infuse blood or fluid from the canister back into the patient. Contraindications There are no known contraindications. Do not use in oxygen rich environment. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Siena, Italy 2023 Bryn Mawr Communications II, LLC. (EXTRACT-PE). Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. 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. Fluoroscopy showed additional thrombus in the tibioperoneal trunk (TPT) (, Final fluoroscopy of the left leg showed restored distal runoff (. 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 . Enter your email address and we will contact you. Desert Radiology Mean PA pressure at the start of the case was 35 mm Hg. Penumbra, Inc. CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to provide advanced deliverability and torqueability within the body. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Poor flow through the left TPT. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Penumbra Announces U.S. Commercial Availability of INDIGO System Do not use in oxygen rich environment. 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. Real-world case examples of Indigo System Lightning 12 Intelligent Aspiration for pulmonary embolism, plus insight into the science behind computer-aided mechanical aspiration and outlooks on PERT development in 2022. 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. Real-world use of the Indigo System Lightning 7 and Lightning 12 Intelligent Aspiration in arterial, pulmonary embolism, and venous cases. It is low-profile and deliverable to all vascular territories in the pulmonary circulation. 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. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Contraindications There are no contraindications. 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 system designed to reduce blood loss and the need for clot-dissolving drugs, which . This website is intended for US audience only. Icahn School of Medicine at Mount Sinai Semin Dial. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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). Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. 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 enables clot detection so the physician knows when . As presented on November 21, 2019, at VEITH 2019 by Dr. Gianmarco de Donato, University of Siena, Italy. Pulmonary embolism (PE) is a condition that occurs when blood clots, typically traveling from the veins in the legs, get caught in the arteries of the lungs.

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