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Desert Radiology The Next Generation of Thrombus Removal | Penumbra Inc 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. Ask the Experts: How Do You Treat (and Avoid) Recurrent Varicose Veins? Figure 1. 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.. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 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. 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 . Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. According to the American Heart Association, PE affects roughly 367,000 Americans per year.1. 2011;17:283-289. doi: 10.4261/1305-3825.DIR.3687-10.2, 3. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Maintain a constant infusion of appropriate flush solution. 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.. Otherwise, this could result in degradation of the performance of this equipment. Do not re-infuse blood or fluid from the canister back into the patient. 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. All Rights Reserved Privacy Policy. Figure 2. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 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. Immediately postprocedure, a decrease in PA pressure from 35 to 27 mm Hg was observed. Copyright 2022 Penumbra, Inc. All rights reserved. Henderson Hospital Image showing the total thrombus removed. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. 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. o The Indigo catheters vary in diameters from 3.4Fr to 12Fr. Risk Information. Figure 3. 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. Figure 2. The patients left leg was cool to the touch with signs of paresthesia but with motor function still intact. 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. Do not use kinked or damaged devices. Do not use open or damaged packages. Warnings/Precautions The canister is intended for single use only. PEN recently announced the commercial availability of its INDIGO System Lightning 7 in the United States. Powered by the Penumbra ENGINE , Lightning 7 and Lightning 12 combine the new Indigo System CAT7 and CAT12 Aspiration Catheters with Lightning Intelligent Aspiration, a unique computer-aided clot detection technology that can differentiate between clot and blood, designed to reduce blood loss and the need for clot-dissolving drugs, which . The Indigo Aspiration System provides a treatment option that is now cleared by the FDA to treat PE. rosen011@umn.edu Do not reuse. Do not reuse. The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE . Catheters & Separators. Thomas S. Maldonado, MD 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. Single-session management of PE using the Indigo System CAT8 allows physicians to treat emergent patients.