indigo system lightning 12

Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. A preliminary analysis of the first 143 patients showed a technical success (defined as complete or near-complete revascularizationTIMI 2-3 flow) after thromboaspiration procedure alone in 89.5%. Catheters & Separators. Figure 6. The Indigo System with Lightning Intelligent Aspiration and Separators is indicated for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous . CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. Immediately postprocedure, a decrease in PA pressure from 35 to 27 mm Hg was observed. Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the PENUMBRA ENGINE as they can interfere with and result in degradation of the performance of the equipment. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. of Medicine We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Access was gained through the groin using an 8-F Destination sheath (Terumo Interventional Systems). Venogram showing thrombosis of the left FV and CFV. The Indigo System of catheters are trackable, deliverable, and can provide a nice treatment option for complex patients. This procedure time has been embraced by countless interventionalists concerned about prolonged case times with other thromboaspiration technologies. Warnings/Precautions The canister is intended for single use only. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Many of the first-generation mechanical endovascular devices for thrombus removal have failed to be adequately successful or have been associated with unacceptable complication rates. Upon arrival to the hospital, physical examination and a Doppler ultrasound examination revealed absent pulses in the left foot. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Created with Sketch. 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. Figure 2. Maintain a constant infusion of appropriate flush solution. Author S Jay Mathews 1 Affiliation 1 Bradenton Cardiology Center, Manatee . The means of mains disconnect is to remove the power cord. 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 (. Otherwise, this could result in degradation of the performance of this equipment. Potential adverse . Do not block bottom air vents. 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. 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. 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. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Precautions The device is intended for single use only. J Vasc Surg. 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. Minneapolis, Minnesota Director of Interventional Radiology The INDIGO SEPARATOR is not intended for use as a guidewire. Do not use kinked or damaged devices. Otherwise, this could result in degradation of the performance of this equipment. Do not reuse. At the 30-day follow-up, the patient no longer had residual shortness of breath or exertional dyspnea. When the catheter is engaged on thrombus or embolic material, the clicking sound ceases. Do not use in an oxygen rich environment. 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. Betsy Merryman Stainless steel hypotube; Large lumen size and circumferential sweep enables maximized thrombus engagement; Figure 5. Low-dose tPA was dripped into the left and right lobes of the PA. Blood clots in the lungs can block the lungs from absorbing oxygen, causing strain on the heart and other organs. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Disclosures: None. Good Samaritan Hospital Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Plus, get our latest issues & supplements delivered to your inbox each month. 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. The Penumbra Indigo System Separator is intended for use with our Indigo Systems CAT family of catheters to enable the removal of a wide range of thrombus. The patients right leg was completely cold, insensate, and immobile from the thigh down. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. o The Indigo catheters vary in diameters from 3.4Fr to 12Fr. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 2. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. The means of mains disconnect is to remove the power cord. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The thromboaspiration with the Indigo System was particularly useful in situations of multilevel vessel acute occlusion. The sustained aspiration from the Penumbra ENGINE provides constant uninterrupted full-vacuum aspiration throughout the procedure, addressing the constraints of syringe-based large-bore embolectomy, which include vacuum dropoff from the syringe filling with fluid. CAT12 features a large 0.131-inch lumen and angled tip for additional circumferential sweep (Figure 2). A 48-year-old man presented with a 3-day history of acute shortness of breath and chest pressure. 2019;140:e774-e801. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. NYU Langone Health Figure 1 shows a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism in the tibial and plantar arteries. The Indigo Aspiration System Lightning 12 granted FDA approval. The major adverse event rate in EXTRACT-PE was 1.7%, and patients had a median intensive care unit stay of < 1 day. Schwartz-Buckley Professor of Surgery, Vascular Division Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Semin Dial. This website is intended for US audience only. Lightning was hooked up to the Indigo System Catheter CAT12 and placed into the access sheath. Professor, FIU Herbert Wertheim College When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. (EXTRACT-PE). 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. Device Problem Adverse Event Without Identified Device or Use Problem (2993) The product was not returned for evaluation. Contraindications There are no known contraindications. Do not use kinked or damaged devices. Lightning 12 and Separator 12 are designed for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. If the cause cannot be determined, withdraw the device or system as a unit. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 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. 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 . Of note, the patient was not a good candidate for thrombolysis due to retroperitoneal hemorrhage from lymph node biopsy several days earlier. 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Prior to use, please refer to the . Associate Professor of Vascular Surgery Figure 3. Made of laser-cut hypotube technology, the CAT12 is Penumbras most trackable and torqueable catheter to date. 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. 2014;59:729-36. Maintain a constant infusion of appropriate flush solution. doi: 10.1161/CIR.0000000000000707. Do not reuse. Department of Medicine, Surgery and Neuroscience 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. Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM Created with Sketch. 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 . Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 2018;29:92-100. doi: 10.1016/j.jvir.2017.08.019. Manhattan Veterans Administration Hospital Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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. Director, Venous Thromboembolic Center and Aortic Center 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. Image showing the total thrombus removed. Created with Sketch. Lightning 12 combines the Indigo System CAT12 Aspiration Catheter with .

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