Do not use in oxygen rich environment. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Penumbra ENGINE. Figure 3. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. University of Massachusetts Medical School Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Copyright 2023 Penumbra, Inc. All rights reserved. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. S. Jay Mathews, MD, MS, FACC Director of Cardiac Catheterization Lab, PERT & Structural Heart INDIGO Aspiration System Indication for Use The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. kolskiwellness@gmail.com . In our practice, we have been able to more accurately define percutaneous transluminal coronary angioplasty and stent length as a result of this increased visualization. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Kingsport, Tennessee If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. 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. K180412. Catheters & Separators. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. Figure 1. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Penumbra's Indigo Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Separator 8, 150 cm Length, 0.072 in. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. 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. Gus Theodos, MD, FACC, FSCAI Figure 2. After IVUS, the stent was dilated to 3.75 mm. With a maximised inner diameter of 0.08 (2.1 mm) and a 7 French (2.3 mm) outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. Mechanical power aspiration with a continuous vacuum source and large lumen aspiration catheter was first introduced in the neurovascular space when Penumbra revolutionized thrombus removal for acute ischemic stroke patients. Return all damaged devices and packaging to the manufacturer/distributor. No modification of this equipment is allowed. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. The treatment of arterial and venous thrombus is challenging. 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. Order Qty. PENUMBRA ENGINE Indication for Use The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. N Engl J Med. Caution: 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. 0 cm from the hub. Possible complications include, but are not limited to, the following: We presented our initial experience at the American College of Cardiologys (ACC) 68th Annual Scientific Session, which showed promising results for mechanical power aspiration for thrombus removal during percutaneous intervention using CAT RX.3 This retrospective case series included 59 patients from four institutions around the United States. Return all damaged devices and packaging to the manufacturer/distributor. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. If the cause cannot be determined, withdraw the device or system as a unit. Vedantham S, Goldhaber SZ, Julian JA, et al. 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. Potential Adverse Events Only use replacement fuse with correct rating (see Table 1 for fuse rating). Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. $399.00 EACH. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Results of EXTRACT-PE Trial presented at Vascular InterVentional Advances (VIVA) Annual Meeting Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced that the EXTRACT-PE trial successfully met the primary endpoints, demonstrating the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with . A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 (Penumbra, Inc.) are indicated for the removal of fresh soft emboli and thrombi from vessels in the coronary and peripheral vasculature. Precautions The device is intended or single use only. She had acute tubular necrosis with minimal urine output at the time of transfer. (CAT3, CAT RX, CAT5, CAT6, CAT8, and CATD) and patented Separator technology, which maintains continuous aspiration and helps limit clogging of the catheters tip during the procedure. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. The INDIGO Aspiration System is intended to serve as a conduit to assist in thrombus removal and restoration of blood flow in the peripheral vasculature and for the treatment of pulmonary embolism. The Indigo Aspiration System is contraindicated in: It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. 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. 5, 19. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Possible complications include, but are not limited to, the following: acute vessel occlusion; air embolism; allergic reaction and anaphylaxis from contrast media or device material; anemia; arrhythmia; arteriovenous fistula; cardiac injury, cardiac perforation, cardiac tamponade; cardio-respiratory arrest; compartment syndrome; death; emboli; emergent surgery; foreign body embolization; hematoma or hemorrhage at access site; hemoptysis; hemorrhage; hypotension/hypertension; infarction leading to organ damage; infection; ischemia; myocardial infarction; neurological deficits including stroke; pneumothorax; pseudoaneurysm; renal impairment or acute renal failure from contrast media; residual thrombus due to inability to completely remove thrombus or control blood flow; respiratory failure; valvular damage; vessel spasm, thrombosis, dissection (intimal disruption), or perforation. Figure 2. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 22. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Relying on a different mechanism of action, power aspiration with CAT RX and Penumbra ENGINE was able to extract the thrombus intact; thus restoring flow through the graft. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. The complaint indicated that the cat8 was kinked during the procedure. Warnings This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. With S. Jay Mathews, MD, MS, FACC; Chris Metzger, MD; Waqas R. Qureshi, MD, MS; Jawairia Sahar K. Mirza, MBBS; Gus Theodos, MD, FACC, FSCAI; Brian Kolski, MD; and Suhail Dohad, MD, FACC. Available in a selection of sizes, the CAT family can enable access to distal peripheral vessels of the upper and lower extremities, including below the knee. This website is intended for US audience only. These data are encouraging and have led to the next stage in data collection through the CHEETAH studya 400-patient, prospective, observational study evaluating the initial safety and performance of the Indigo Aspiration System CAT RX. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. The Indigo Separator 4 is not intended for use as a guidewire. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . The means of mains disconnect is to remove the power cord. 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. 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. Director of Cardiac & Peripheral Cath Lab The low-profile catheter and Penumbra . window.dataLayer = window.dataLayer || []; The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. The catheters (CAT3, CAT RX*, CAT5, CAT6, CAT8, CATD) vary in diameters from 3.4 to 8 F and lengths of 50 to 150 cm to . Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. The advantages of CAT RX with Penumbra ENGINE include the potential to remove the thrombus intact and reduce the potential of systemic embolization while also increasing the visualization of the underlying stenosis and distal vessel. The CAT family of catheters is the foundation of Penumbra's Indigo system. After one pass with CAT RX, the initial occlusion was removed. The INDIGO Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems and certain central circulatory system conditions such as pulmonary emboli using continuous aspiration. sjaymathewsmd@gmail.com Use prior to the Use By date. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. No conversations found. Use only waterbased solvents for cleaning. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon Two passes of CAT RX with the Penumbra ENGINE resulted in TIMI 3 flow restoration and retrieval of the distal emboli from the PDA (Figure 3). The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established.
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