Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. 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. J Vasc Interv Radiol. 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. The Indigo System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Tip directionality for circumferential aspiration, Live feedback during procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposablePenumbra ENGINE Canister. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. N Engl J Med. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. 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. This case illustrates the vast improvement in aspiration technology with an easy-to-deliver, trackable catheter that maintains sustained aspiration for the duration of the procedure. The atraumatic tip and small catheter French size of the CAT8 device allows for easy tracking and maneuvering through the vasculature and selective debulking of thrombus from lobar branches of the pulmonary arterial tree. This ability of lobar thrombectomy likely allowed EXTRACT-PE to be the first endovascular IDE, pulmonary embolism trial that has reported statistically significant reduction in on-table systolic pulmonary artery pressures. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. Penumbra, a US-based provider of advanced therapies, has enrolled the first patient into the CHEETAH clinical study, designed to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Aspiration Tubing Intended Use These pages are not intended for patients or for members of the general public. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. 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. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. There are no contraindications. Penumbras Indigo Aspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism and/or certain central circulatory system conditions such as pulmonary emboli. Indigo System CAT RX tracking through the distal posterior tibial artery. 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. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Do not reuse. The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum to our catheters to remove thrombus in vessels of various sizes. 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. Circulation. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. The treatment of arterial and venous thrombus is challenging. window.dataLayer = window.dataLayer || []; Contraindications There are no contraindications. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 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. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . Equipment is not safe for MR use. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. Initial angiography revealed an occlusion of the distal RCA. Copyright 2023 Penumbra, Inc. All rights reserved. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Preprocedure TIMI 0 flow was seen in 76.3% of patients; TIMI 3 flow immediately post-CAT RX was demonstrated in 93.2% of patients. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). CAT7 and CAT12 are the next generation of the Indigo System catheters. 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. The patient remained on cangrelor with no need for tirofiban. Return all damaged devices and packaging to the manufacturer/distributor. These pages are not intended for patients or for members of the general public. Figure 1. Manual aspiration suffers from diminished aspiration force as fluid fills in the syringe, potentially resulting in systemic embolization during catheter removal, as shown in the TOTAL trial published in 2015 (Figure 1).1 Subgroup analysis of patients with high thrombus burden was explored that highlighted the potential for improved outcomes. Figure 3. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. 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. Use prior to the Use By date. 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. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. Interventional Cardiology The CAT family of catheters is the foundation of Penumbra's Indigo System. This website is intended for US audience only. After one pass with mechanical thrombectomy using CAT RX, the thrombus was removed and flow was restored to the pedal arch via the plantar posterior tibial artery (Figure 2 and Figure 3). Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Do not re-infuse blood or fluid from the canister back into the patient. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. Please email [email protected] or call us at 877-663-8686 and we will try to locate the product with our suppliers. INDIGO System LIGHTNING Aspiration Tubing Intended Use . Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. The Indigo System CAT RX was the preferred choice for mechanical aspiration thrombectomy to remove the distal emboli below the knee in the posterior tibial artery. 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 INDIGO Aspiration Tubing: The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. The Indigo System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. This content is not intended to offer professional medical advice. Figure 1. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. The cerebral vasculature Figure 3. Bradenton Cardiology Center/Manatee Memorial Hospital N Engl J Med. [email protected] The CAT family of catheters is the foundation of Penumbra's Indigo System. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 1. Created with Sketch. Use prior to the Use By date. Distal OD, Sterile, Single-Use, Disposable, For CAT8 Penumbra Devices, Indigo Aspiration Catheters, Removal of Fresh, Soft Emboli and Thrombi from Vessels of Peripheral Arterial and Venous Systems Sista A. Indigo aspiration system for acute pulmonary embolism. The device is intended for single use only. Mathews SJ, Brown C, Kolski B, et al. [email protected] [email protected] Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious . LIGHTNING Aspiration Tubing is a sterile aspiration tubing component of the INDIGO Aspiration System and 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.