Department of Diagnostic, Molecular, and Interventional Radiology 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. Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. MHealth Fairview System Medical Director for Interventional Radiology Operations The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Traditionally, tPA or open embolectomy were the primary treatment options for acute-to-chronic lesions. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. Vessel patency is assessed using the thrombolysis in myocardial infarction (TIMI) score classifications, both before and after the use of the device. Penumbra Announces the European Launch of the Indigo System With Contraindications There are no contraindications. Return all damaged devices and packaging to the manufacturer/distributor. 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. Director, Venous Thromboembolic Center and Aortic Center should be used no closer than 12 inches (30 cm) to any part of LIGHTNING Aspiration Tubing. Executive Medical Director of Interventional Radiology & Vascular Imaging Penumbra, Inc. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Potential adverse . Figure 2. Contraindications There are no known contraindications. The Indigo Aspiration System Lightning 12 granted FDA approval. 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. This website is intended for US audience only. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Media Relations: 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. The INDIGO SEPARATOR is not intended for use as a guidewire. 2011;17:283-289. doi: 10.4261/1305-3825.DIR.3687-10.2, 3. Mean PA pressure postintervention was 21 mm Hg. The primary outcome is the rate of TIMI 2-3 revascularization after treatment using the Indigo System. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. 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. Do not re-infuse blood or fluid from the canister back into the patient. 5. Return all damaged devices and packaging to the manufacturer/distributor. The Indigo Aspiration System, along with the Penumbra ENGINE and Indigo CAT8, provide a frontline treatment option for PE patients that can lower on-table PA pressures and reduce RV/LV ratios by 27.3%, per their investigational device exemption trial, EXTRACT-PE.1 The trial and our case experience at the University of Minnesota with CAT8 show that sustained aspiration with the Indigo System can provide safe mechanical relief in the treatment of PE. 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 3. 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. 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. 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. It is low-profile and deliverable to all vascular territories in the pulmonary circulation. Figure 1. To prevent fire or shock hazard, use a replacement power cord of equal rating. With Lightning 8, we were able to clear the loft lobar branch and detect that we had established substantial inflow and outflow so we could move to the next affected lobe. Do not resterilize or reuse. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Precautions The device is intended for single use only. INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 Indication for Use 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. Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM In particular, the Indigo catheters vary from 3 to 8 Fenabling the operator to remove thrombus from small vessels such as the pedal arch but also from large vessels such as the aorta or iliac arteries, due to the circumferential aspiration from the tip shapes offered in CAT8. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Good Samaritan Hospital 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. Maintain a constant infusion of appropriate flush solution. Do not resterilize or reuse. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Perspectives on PE Care Using Penumbra's Indigo System With Lightning At discharge, there have been no adverse device events, and clinical success at 1 month (defined as the absence of death and limb loss) is 98.6%.4. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo The SEP12 was introduced to help clear the lumen of the catheter due to the heavy thrombus burden. The continuously powered engine pump , which is activated by a single touch, achieves a negative suction pressure of 29 inHg, a nearly pure vacuum. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Sanger Heart and Vascular Institute Now, the goal with thrombus removal in PE is to safely and effectively remove thrombus and potentially reduce treatment time. Lightning was hooked up to the Indigo System Catheter CAT12 and placed into the access sheath. Frank R. Arko III, MD If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Lightning 12 combines the Indigo System CAT12 Aspiration Catheter with . Disclosures: None. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use 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. LIGHTNING Aspiration Tubing Indication for Use The Indigo System of catheters are trackable, deliverable, and can provide a nice treatment option for complex patients. 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). The patient had a history of lower left extremity venous thrombus dating back to 2013, with chronic residual nonocclusive popliteal vein thrombus in 2018. This procedure time has been embraced by countless interventionalists concerned about prolonged case times with other thromboaspiration technologies. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. 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. If repositioning of the INDIGO Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard catheter and guidewire techniques. 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. The Indigo System has demonstrated high rates of revascularization with consistent success. The catheter is robust and trackable, and the large lumen allows for thrombectomy either with a guidewire in place or without a guidewire. Learn more about Lightning. Notably, Lightning 7 is designed . This new thromboaspiration technology allows for clot removal and potential reduction in right heart and PA pressure. Miami Cancer Institute In addition to Lightning 12, the Indigo System also now includes Lightning 8 which combines the Indigo System CAT 8 Aspiration Catheter with Lightning Intelligent Aspiration for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. Figure 5. 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. The Penumbra Indigo System Separator is intended for use with our Indigo System's CAT family of catheters to enable the removal of a wide range of thrombus. 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. Computer-Aided Thrombus Removal Using Penumbra's Lightning 7 and Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Such results give more evidence for a shift of treatment recommendation toward endovascular options in the patients with ALI, as already suggested by the recent European Society of Cardiology/European Society for Vascular Surgery guidelines. Rethinking Thrombus Removal With the Indigo System: Introducing The new HTORQ angle is complemented by the large lumen when accessing wall-adherent thrombus in the venous space. Contraindications There are no known contraindications. Use prior to the Use By date. 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. Department of Medicine, Surgery and Neuroscience Localization of the thrombus was quite variable in our cohort of patients, although in the majority of cases (67%), patients presented with thrombus in the popliteal or BTK vessels. Enter your email address and we will contact you. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. The major adverse event rate in EXTRACT-PE was 1.7%, and patients had a median intensive care unit stay of < 1 day. Determining and Applying Appropriate Use of Venous Care, With Kathleen Ozsvath, MD, and Elna Masuda, MD, left-arrow February 2022. 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. Otherwise, this could result in degradation of the performance of this equipment. 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. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Do not use kinked or damaged devices. 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. Penumbra Indigo System | Vascular Thrombectomy Contraindications Not for use in the coronaries or the neurovasculature. Created with Sketch. The patients right leg was completely cold, insensate, and immobile from the thigh down. When in free-flowing blood, this technology automatically stops aspirating blood and hence limits unnecessary loss of blood. A 57-year-old man presented with acute-onset left calf pain for the past 10 days and had recently taken a 4-hour flight. 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. The EXTRACT-PE study completed in 2019 evaluated the safety and efficacy of the Indigo Aspiration System in the management of submassive PE. Investor Relations: The Indigo System Catheter CAT8 was used across 22 sites in the United States in patients with submassive PE who did not receive thrombolytics (98.3%), with a right ventricular/left ventricular (RV/LV) ratio reduction of 27.3% at 48 hours. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 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. 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. Penumbra's Newest Generation of Indigo Aspiration System Receives FDA Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Atrium Health When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. (Photo: Business Wire). The patient also had a history of bilateral PE dating back to October 2017, at which point rivaroxaban was prescribed. CAT12 features a large 0.131-inch lumen and angled tip for additional circumferential sweep (Figure 2). 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. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. The Indigo Aspiration System provides a treatment option that is now cleared by the FDA to treat PE. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The results may not be predictive of all patients. 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. rosen011@umn.edu For more information, visit https://www.penumbrainc.com/indigo-lightning/. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Figure 1 shows a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism in the tibial and plantar arteries. 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. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Precautions The device is intended or single use only. 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. Created with Sketch. 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. Thrombolysis is not a universal option for all patient groups, especially if the patient has an absolute or relative contraindication to a fibrinolytic agent. Schwartz-Buckley Professor of Surgery, Vascular Division Image of thrombus aspirated using the Indigo CAT12 Aspiration Catheter. 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. The acute pulmonary embolism (PE) treatment paradigm is evolving to treat patients that have emergent symptoms and are unable to tolerate long thromboaspiration procedures.
