For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. 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). 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 computer-aided clot detection technology that can differentiate between clot and blood. Precautions The device is intended for single use only. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. New Indigo System By Penumbra - Medical Device News Magazine Thomas S. Maldonado, MD In my radiology practice, Ive seen firsthand the challenges medical practitioners face while treating difficult medical conditions, stated Dr. Teigen in the announcement. The patient had a history of lower left extremity venous thrombus dating back to 2013, with chronic residual nonocclusive popliteal vein thrombus in 2018. If the cause cannot be determined, withdraw the device or system as a unit. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. The new HTORQ angle is complemented by the large lumen when accessing wall-adherent thrombus in the venous space. doi: 10.1111/j.1525-139X.2012.01104.x. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. 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. 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 use kinked or damaged devices. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Circulation. Do not block bottom air vents. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Investor Relations: Ripal T. Gandhi, MD, FSIR, FSVM We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change. 1. Veryan Medical Will Support Commercialization of Walk Vasculars Jeti Thrombectomy System in Germany, left-arrow Semin Dial. (Photo: Business Wire). Low-dose tPA was dripped into the left and right lobes of the PA. 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. Using the Lightning 12 and SEP12 (Penumbra, Inc.), we removed a huge clot from the iliac vein with a retrograde approach to the thrombus. INDIGO Aspiration System Indication for Use No modification of this equipment is allowed. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. 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). Disclosures: Consultant to Penumbra, Inc. Lightning Intelligent Aspiration comes packaged with the Indigo CAT 8 or the newest CAT12, the next generation of the Indigo System catheters. 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. Sanger Heart and Vascular Institute Created with Sketch. This website is intended for US audience only. Individual results may vary depending on patient-specific attributes. With contributions from Edoardo Pasqui, MD; Carlo Setacci, MD; and Giancarlo Palasciano, MD, Surgical management of lower extremity acute limb ischemia (ALI) has been considered the preferred treatment for years. The device is intended for single use only. Penumbra's Indigo System With Lightning Intelligent Aspiration Warnings/Precautions The canister is intended for single use only. 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 use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. CT revealed bilateral ALI (Figure 1). J Vasc Surg. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. 1Virani, S.S. et al. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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. Blood clots in the lungs can block the lungs from absorbing oxygen, causing strain on the heart and other organs. 1. 2019;140:e774-e801. Poor flow through the left TPT. Merryman Communications Penumbra has changed the landscape of healthcare by providing truly innovative solutions for a wide realm of medical challenges. By capturing the clot without maceration and under high aspiration power, the risk for distal emboli may be minimized. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event. 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 . 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. Restored distal flow to the left TPT. Created with Sketch. As presented on November 21, 2019, at VEITH 2019 by Dr. Gianmarco de Donato, University of Siena, Italy. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. When 4 solid illuminated bars on the . 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.