indigo system lightning 12

Only use replacement fuse with correct rating (see Table 1 for fuse rating). 2021 Nov 1;48(5):e217571. Minneapolis, Minnesota Lightning 12 combines the Indigo System CAT12 Aspiration Catheter with . Henderson Hospital Heart disease and stroke statistics2020 update: a report from the American Heart Association. COVID has increased the awareness of the need for therapies that remove blood clots, and we are thrilled with the FDA clearance of the PE treatment indication for Lightning 12.. The catheters, which were initially designed for intracranial navigation for the treatment of acute stroke, are provided with an atraumatic tip. 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; arteriovenous fistula; cardiac injury; cardio-respiratory arrest; death; device malfunction; distal embolization; emboli; excessive blood loss; 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; hemoptysis; respiratory failure; thromboembolic events. The Indigo System Lightning 12 was launched in July and is available immediately for patients needing interventional treatment for PE. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 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. Miami Cardiac and Vascular Institute Otherwise, this could result in degradation of the performance of this equipment. 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. Ballad Health System CVA Heart & Vascular Institute 2020;59:173-218. doi: 10.1016/j.ejvs.2019.09.006. Use prior to the Use By date. After adjunctive endovascular (angioplasty, stenting, or lysis), TIMI 2-3 was reached in up to 95.3% of patients. 2020;141(9):e139e596. The SEP12 was introduced to help clear the lumen of the catheter due to the heavy thrombus burden. All Rights Reserved Privacy Policy. Indication For Use Copyright 2022 Penumbra, Inc. All rights reserved. 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. A 47-year-old woman with no previous history of thromboembolism presented with sudden-onset PE. The INDIGO SEPARATOR is not intended for use as a guidewire. Real-world use of the Indigo System Lightning 7 and Lightning 12 Intelligent Aspiration in arterial, pulmonary embolism, and venous cases. The Indigo Aspiration System with Lightning 12 removes these difficult-to-access, life-threatening clots, potentially reducing the need for thrombolytics and their associated ICU stays. Real-world case examples of Indigo System Lightning 12 Intelligent Aspiration for pulmonary embolism, plus insight into the science behind computer-aided mechanical aspiration and outlooks on PERT development in 2022. Figure 1. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. In this case, the PE patient had an extremely high PA pressure of 35 mm Hg, which we were able to significantly reduce by 40%. 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. In my radiology practice, Ive seen firsthand the challenges medical practitioners face while treating difficult medical conditions, stated Dr. Teigen in the announcement. MHealth Fairview System Medical Director for Interventional Radiology Operations Use only water-based solvents for cleaning. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. If the cause cannot be determined, withdraw the device or system as a unit. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The wire was removed, and the CAT8 was used to remove thrombus from the popliteal artery. Otherwise, this could result in degradation of the performance of this equipment. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Lightning 12 and Lightning 8 expand the already broad offering of CAT8, CATD, CAT6, CAT5, and CAT3 and are paired with Penumbra ENGINE, the companys proprietary continuous, mechanical vacuum aspiration pump. Figure 2. Warnings/Precautions The canister is intended for single use only. Equipment is not safe for MR use. 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. Return all damaged devices and packaging to the manufacturer/ distributor. 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. Figure 8. Do not block bottom air vents. Miami, Florida 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. 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. Contraindications Not for use in the coronaries or the neurovasculature. 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. 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. D. Chris Metzger, MD Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Access was gained using an 8-F sheath in the left popliteal vein, which was then upsized to a 12-F sheath. Otherwise, this could result in degradation of the performance of this equipment. Do not use kinked or damaged devices. Do not re-infuse blood or fluid from the canister back into the patient. 2018;29:92-100. doi: 10.1016/j.jvir.2017.08.019. 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. Do not use in oxygen rich environment. The Lightning 12 addition to the Indigo Aspiration System is a formative development in the thrombectomy space. 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. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 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. INDIGO Aspiration System with LIGHTNING Aspiration Tubing - Indication for Use . Director, Venous Thromboembolic Center and Aortic Center Scan showing preoperative left venous thrombus. Created with Sketch. 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. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Contraindications Not for use in the coronaries or the neurovasculature. The patient, an active smoker, also had a history of pulmonary hypertension and hypercholesterolemia. on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. o The Indigo catheters vary in diameters from 3.4Fr to 12Fr. Penumbra's Indigo Aspiration System Lightning 12 received FDA clearance for the treatment of pulmonary embolism. Learn more about Lightning. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. When 4 solid illuminated bars on the . Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Co-Director, Aortic Institute Lightning 12 Intelligent Aspiration. Fluoroscopy showed additional thrombus in the tibioperoneal trunk (TPT) (, Final fluoroscopy of the left leg showed restored distal runoff (. Semin Dial. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. 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 . 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. Figure 2. Total aspiration time was 34 minutes. 2011;17:283-289. doi: 10.4261/1305-3825.DIR.3687-10.2, 3. Figure 3. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. 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). 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). Advancement of the CAT8 and CAT6 through the popliteal and tibial arteries (A, B). 1. Maintain a constant infusion of appropriate flush solution. 2. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. The Indigo System Lightning 12 is the companys newest generation aspiration system for peripheral thrombectomy. To prevent fire or shock hazard, use a replacement power cord of equal rating. Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use. 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. The Indigo System with . Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. At Penumbra, I have a profound opportunity to change the course of healthcare delivery for people living with vascular disease. Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. Thomas S. Maldonado, MD If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Disclosures: Consultant to Penumbra, Inc. A 68-year-old man presented with a sudden coolness in both legs after stopping apixaban therapy for 3 days. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Precautions The device is intended or single use only. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Merryman Communications Lightning 12 combines the new Indigo System CAT12 aspiration catheter with Lightning intelligent aspiration, enabling physicians to focus on optimising thrombus removal using the system's clot detection mechanism. 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.

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