If the cause cannot be determined, withdraw the device or system as a unit. Figure 3. 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. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Lightning Intelligent Aspiration allows physicians to optimize the thrombus removal needed to complete venous thrombus procedures that would otherwise be more complicated. Dek Z, Strube H, Sadeghi-Azandaryani M, et al. Return all damaged devices and packaging to the manufacturer/ distributor. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. An intuitive clicking sound is made by the device that signals that one is in free-flowing blood. Vessel patency is assessed using the thrombolysis in myocardial infarction (TIMI) score classifications, both before and after the use of the device. Merryman Communications Contraindications There are no known contraindications. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE (Figure 1). This new thromboaspiration technology allows for clot removal and potential reduction in right heart and PA pressure. Created with Sketch. It will reduce the service life of the PENUMBRA ENGINE. Otherwise, this could result in degradation of the performance of this equipment. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change. Do not use in an oxygen rich environment. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Blood clots in the lungs can block the lungs from absorbing oxygen, causing strain on the heart and other organs. Presented at Vascular InterVentional Advances (VIVA) 2019; November 6, 2019; Las Vegas, Nevada. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Director, Venous Thromboembolic Center and Aortic Center 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 re-infuse blood or fluid from the canister back into the patient. As PE treatment options continue to grow, the EXTRACT-PE results with the Indigo System serve as a promising data set in helping move the PE landscape forward. Resterilization and/or reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Penumbra's newest generation of Indigo aspiration system receives FDA Figure 2. The Indigo Separator is advanced and retracted through the corresponding size Indigo catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip. Lightning 7 a and Lightning 12 a are made of laser-cut hypotube technology, designed to increase trackability and torqueability. The Indigo Aspiration System Lightning 12 granted FDA approval. 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. 4. Executive Medical Director of Interventional Radiology & Vascular Imaging 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 . 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. Thomas S. Maldonado, MD investors@penumbrainc.com 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. 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. betsy@merrymancommunications.com Preprocedural CT of the patients left pulmonary anatomy. Risk Information. Use prior to the Use By date. 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. Postoperative angiogram showing 100% resolution of thrombus. Do not resterilize or reuse. 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.. Warnings Do not use the INDIGO Aspiration System with a pump other than a 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. The Indigo CAT12 Aspiration Catheter is indicated for removal of fresh, soft emboli and thrombi from vessels of the peripheral venous systems. STRIDE is the newest study from Penumbra evaluating the removal of thrombus with the Indigo Aspiration System in patients with lower extremity ALI. Penumbra's Newest Generation of Indigo Aspiration System Receives FDA J Vasc Surg. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use STRIDE is currently ongoing. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Immediately postprocedure, a decrease in PA pressure from 35 to 27 mm Hg was observed. Betsy Merryman Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 2013;26: E5-7. Do not reuse. The 1:1 torqueability of the catheter was especially valuable for aspirating thrombus along the circumference of the larger-diameter iliac veins. In PE cases, patients are often emergent and need interventions that provide immediate relief. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. The catheters, which were initially designed for intracranial navigation for the treatment of acute stroke, are provided with an atraumatic tip. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Figure 1. The patients echocardiogram showed normal RV size and function. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. This website is intended for US audience only. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Enter your email address and we will contact you. Previous Article, Biotronik's Dynetic-35 Iliac Stent Launched in Europe. Precautions The device is intended or single use only. In addition, the RV/LV ratio decreased from 2.26 to 1.09, over a > 50% on-table decrease. Henderson Hospital Return all damaged devices and packaging to the manufacturer/ distributor. The Lightning 12 addition to the Indigo Aspiration System is a formative development in the thrombectomy space. Miami Vascular Specialists 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. 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Throughout each case, Lightning provides procedural feedback via audiovisual cues. We opted for aspiration thrombectomy with the Indigo System Lightning 12 with the 100-cm HTORQ tip (Penumbra, Inc.). The new HTORQ angle is complemented by the large lumen when accessing wall-adherent thrombus in the venous space. INDIGO Aspiration System Indication for Use 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 Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. Figure 1. 2023 Bryn Mawr Communications II, LLC. Designed for single session arterial thrombus removal, New angled tip shape for maximized clot extraction, Dual pressure sensors for real-time flow monitoring, Large lumen size and circumferential sweep enables maximized thrombus engagement, Multi-pitch hypotube for 1:1 torque transfer and advanced deliverability, Indicated for the treatment of pulmonary embolism. Penumbra Announces U.S. Commercial Availability of INDIGO System From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event. Made of laser-cut hypotube technology, the CAT12 is Penumbras most trackable and torqueable catheter to date. D. Chris Metzger, MD Heart disease and stroke statistics2020 update: a report from the American Heart Association. Venogram showing CAT12 in the CIV. Next Article Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. Figure 1. Do not resterilize or reuse. Of note, the patient was not a good candidate for thrombolysis due to retroperitoneal hemorrhage from lymph node biopsy several days earlier. 1Virani, S.S. et al. Use only water-based solvents for cleaning. 2018;29:92-100. doi: 10.1016/j.jvir.2017.08.019.