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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. At Penumbra, I have a profound opportunity to change the course of healthcare delivery for people living with vascular disease. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. Catheters & Separators. 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. 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. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. The wire was removed, and the CAT8 was used to remove thrombus from the popliteal artery. 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. It will reduce the service life of the PENUMBRA ENGINE. Indigo system with Lightning 7 and Lightning 12 launched in Europe Angiography after Indigo power aspiration and popliteal aneurysm repair with a stent graft (Viabahn, Gore & Associates) revealed a patency of the tibial (A) and plantar (B) vessels. Restored distal flow to the left TPT. 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. Lightning Intelligent Aspiration. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Heart disease and stroke statistics2020 update: a report from the American Heart Association. Minneapolis, Minnesota In addition, the RV/LV ratio decreased from 2.26 to 1.09, over a > 50% on-table decrease. All Rights Reserved Privacy Policy, 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; D. Chris Metzger, MD, Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM. Penumbra has changed the landscape of healthcare by providing truly innovative solutions for a wide realm of medical challenges. Additional information about Penumbras products can be located on Penumbras website at http://www.penumbrainc.com/healthcare-professionals. Atrium Health IVUS image showing May-Thurner narrowing of the left CIV and thrombus in the iliac vein. Penumbra Announces the European Launch of the Indigo System With Lightning is paired with CAT8 or CAT12. Access was gained through the groin using an 8-F Destination sheath (Terumo Interventional Systems). 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Do not resterilize or reuse. Potential adverse . The patients right leg was completely cold, insensate, and immobile from the thigh down. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. PEN recently announced the commercial availability of its INDIGO System Lightning 7 in the United States. Author S Jay Mathews 1 Affiliation 1 Bradenton Cardiology Center, Manatee . The catheter is robust and trackable, and the large lumen allows for thrombectomy either with a guidewire in place or without a guidewire. Precautions The device is intended or single use only. Figure 5. 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. Lightning is paired with CAT8 or CAT12. Figure 4. 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. This procedure time has been embraced by countless interventionalists concerned about prolonged case times with other thromboaspiration technologies. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Do not re-infuse blood or fluid from the canister back into the patient. CT showed a bilateral PE with right heart strain. Next Article 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 (. Of note, the patient was not a good candidate for thrombolysis due to retroperitoneal hemorrhage from lymph node biopsy several days earlier. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Mentors and Protgs: Conversations on Career and Craft With Alda L. Tam, MD, MBA, FRCPC, FSIR, FACR, The Patient Voice in Chronic Venous Disease Treatment: What We Have and Whats Coming Next, With Kathleen Gibson, MD, FACS, FAVLS, DABVLM; Al Compaan; and Manj Gohel, MBChB, MD, FRCS, FEBVS. Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. Silver, DO, FACC, FSVM, RPVI; Catalin Toma, MD; Pavan Khanna, MD; Mitchell Weinberg, MD; and Andrew Galmer, DO. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Precautions The device is intended or single use only. As part of the Indigo Aspiration System, Lightning 12 (Indigo System CAT 12 Aspiration Catheter with Lightning Intelligent Aspiration) and Separator 12 are now indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems as well as for the treatment of pulmonary embolism. It is low-profile and deliverable to all vascular territories in the pulmonary circulation. Chief, Vascular and Endovascular Surgery With the maximized inner diameter of 0.082 and a 7 French outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. This combination of intelligent aspiration and large-lumen catheter engineering makes Lightning 12 Penumbras most advanced clot removal technology for the treatment of pulmonary embolism. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. This website is intended for US audience only. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Professor of Radiology and Surgery The INDIAN registry is a prospective, multicenter registry designed to investigate, in a controlled setting, the safety and initial efficacy of the Indigo System in the treatment of acute peripheral arterial thromboembolism. Chief of Vascular Surgery Do not re-infuse blood or fluid from the canister back into the patient. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. If repositioning of the INDIGO CAT RX Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard guidewire techniques. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. CAT12 is a large . The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. Figure 2. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. Precautions The device is intended or single use only. Semin Dial. Professor, Cardiovascular Surgery The primary outcome is the rate of TIMI 2-3 revascularization after treatment using the Indigo System. 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 . Do not use in an oxygen rich environment. CT revealed bilateral ALI (Figure 1). Do not use in oxygen rich environment. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Icahn School of Medicine at Mount Sinai 2020;59:173-218. doi: 10.1016/j.ejvs.2019.09.006. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 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. New York University Langone Medical Center New York, New York Figure 1. The catheters, which were initially designed for intracranial navigation for the treatment of acute stroke, are provided with an atraumatic tip. doi: 10.1161/CIR.0000000000000707. Thrombotic disease puts patients at high risk of . Use prior to the Use By date. Do not use open or damaged packages. Regarding the Chief Scientific and Medical Officer appointments, the company advised that Dr. Teigen joins Penumbra immediately and will contribute his extensive scientific and clinical expertise to ongoing and future research and development efforts. Penumbra Indigo System | Vascular Thrombectomy The device is intended for single use only. Copyright 2022 Penumbra, Inc. All rights reserved. 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. 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. (EXTRACT-PE). Lightning 12 combines the Indigo System CAT12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the systems unique clot detection mechanism. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. According to the American Heart Association, PE affects roughly 367,000 Americans per year.1. Blood clots in the lungs can block the lungs from absorbing oxygen, causing strain on the heart and other organs. The Indigo CAT12 represents an advancement in mechanical thrombectomy given its ability to aspirate large-volume thrombus in a single-session setting, which is especially beneficial in larger-lumen vascular beds, such as large-caliber veins as demonstrated in this case. When in free-flowing blood, this technology automatically stops aspirating blood and hence limits unnecessary loss of blood. The 1:1 torqueability of the catheter was especially valuable for aspirating thrombus along the circumference of the larger-diameter iliac veins. Except for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Betsy Merryman Precautions The device is intended for single use only. 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. Associate Professor of Radiology and Surgery 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. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Do not resterilize or reuse. 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. 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. 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. Mean PA pressure at the start of the case was 35 mm Hg. 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. 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. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Disclosures: None. Intravascular ultrasound (IVUS) revealed May-Thurner syndrome, which was treated with stenting in the CIV and EIV; 100% of the clot was resolved (, The newly available Indigo CAT12 Aspiration Catheter (Penumbra, Inc.) was utilized to perform mechanical thrombectomy of the FV, CFV, and EIV and CIV without the use of thrombolytics (, Significant thrombus was aspirated from the Indigo CAT12 Aspiration Catheter (, May-Thurner narrowing of the left CIV was noted and treated with a Vici stent (Boston Scientific Corporation), with IVUS before treatment (, IVUS after thrombectomy and stenting showed a widely patent lumen (. Penumbra Augments Vascular Franchise with Latest Indigo System Launch 2023 Bryn Mawr Communications II, LLC. 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. Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use. 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. If the cause cannot be determined, withdraw the device or system as a unit. Individual results may vary depending on patient-specific attributes. The patient also had a history of bilateral PE dating back to October 2017, at which point rivaroxaban was prescribed. Return all damaged devices and packaging to the manufacturer/distributor. Presented at Vascular InterVentional Advances (VIVA) 2019; November 6, 2019; Las Vegas, Nevada. Industry Prospects Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Internet Explorer presents a security risk. Figure 1. Executive Vice Chairman 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. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The INDIGO SEPARATOR is not intended for use as a guidewire. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. The acute pulmonary embolism (PE) treatment paradigm is evolving to treat patients that have emergent symptoms and are unable to tolerate long thromboaspiration procedures. Use only water-based solvents for cleaning. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Created with Sketch. J Vasc Surg. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. The Indigo System Lightning 12 is the companys newest generation aspiration system for peripheral thrombectomy. 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. February 2022. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. 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. 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. Cincinnati, Ohio Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Venogram showing stents in the left CIV and EIV. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. Henderson Hospital We performed a transjugular access with a 12-F introducer sheath. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Lightning has also demonstrated an 18:1 potential fluid loss savings during bench top testing when used versus the Dynamic Aspiration Tubing. Precautions The device is intended for single use only. A 48-year-old man presented with a 3-day history of acute shortness of breath and chest pressure. 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. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. 5. In my radiology practice, Ive seen firsthand the challenges medical practitioners face while treating difficult medical conditions, stated Dr. Teigen in the announcement. Media Relations: right-arrow 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). Contraindications There are no contraindications. Made of laser-cut hypotube technology, the CAT12 is Penumbras most trackable and torqueable catheter to date. CT revealed that the patient had a bilateral PE with an elevated RV/LV ratio of 2.26, an elevated troponin level of 0.151 g/mL, and PA pressures at 35 mm Hg. Miami Cancer Institute 1. The patient, an active smoker, also had a history of pulmonary hypertension and hypercholesterolemia. 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. o The Indigo catheters vary in diameters from 3.4Fr to 12Fr. Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. 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. 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. Penumbra's Newest Generation of Indigo Aspiration System Receives FDA The thromboaspiration with the Indigo System was particularly useful in situations of multilevel vessel acute occlusion. To prevent fire or shock hazard, use a replacement power cord of equal rating. The Indigo Aspiration System is comprised of several devices: The Indigo System is used as a first-line approach or rescue therapy for arterial and venous thrombotic events. Figure 1. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. CAT 12 is a . The INDIGO SEPARATOR 4 is not intended for use as a guidewire. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Manhattan Veterans Administration Hospital The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. After considering the acute onset of symptoms and the history of thrombosis, we decided to proceed with the Indigo System to treat the bilateral PE in one session. Notably, Lightning 7 is designed . Risk Information. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Diagn Interv Radiol. 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.
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indigo system lightning 12