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. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. Indigo System | Penumbra Inc Figure 2. Created with Sketch. Because the patient was not a candidate for thrombolysis, the decision was made to intervene with the Indigo System CAT8XTORQ115 and SEP 8, which were advanced sequentially into the right then left pulmonary artery. Penumbra Recalls JET 7 Catheters with Xtra Flex -Risk of Mortality Physicians in the USA have published details ofto their knowledgethe "first reported use" of the Indigo aspiration system (Penumbra) to treat cerebral venous sinus thrombosis (CVST) via endovascular thrombectomy.The treated patient underwent successful partial recanalisation of the superior sagittal sinus (SSS) and bilateral transverse sinuses (TS), and experienced . Indigo System CAT RX tracking through the distal posterior tibial artery. Indigo System | Computer-Aided Mechanical Aspiration. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Figure 1. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Throughout each case, Lightning provides procedural feedback via audiovisual cues. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Possible complications include, but are not limited to, the following: Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight 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. 5, 19. Only use replacement fuse with correct rating (see Table 1 for fuse rating). This content is not intended to offer professional medical advice. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. Penumbra, CAT8TORQ85, Penumbra CAT8 Indigo Aspiration Catheter, Torq Penumbra CAT6, Indigo system Aspiration Catheter 6F, 135cm - MedicalEcart PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8 DXE: Back to Search Results: Model Number CAT8XTORQ115KIT-S: Device Problems Break (1069); Physical Resistance/Sticking (4012) Patient Problem No Clinical Signs, Symptoms or Conditions (4582) Event Date 05/19/2021: Figure 2. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. These pages are not intended for patients or for members of the general public. Penumbra, Inc. One Penumbra Place. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). Control angiography immediately after thrombectomy demonstrated restored patency . The Indigo Aspiration System is contraindicated in: Disclosures: Consultant to Penumbra, Inc. An 83-year-old woman transferred from an outside hospital presented with acute shortness of breath, was hypotensive, and was intubated. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. CAT7 and CAT12 are the next generation of the Indigo System catheters. 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. System Chair, Clinical Research Created with Sketch. Director of Cardiac Catheterization Lab, PERT & Structural Heart Do not re-infuse blood or fluid from the canister back into the patient. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). The procedure was completed with the same catheter. INDIGO Aspiration System Intended Use Use prior to the Use By date. Mechanical Power Aspiration With the Indigo - Endovascular Today Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. Return all damaged devices and packaging to the manufacturer/distributor. Do not use open or damaged packages. Enter your email address and we will contact you. 1.10 Summary of Non-Clinical Data As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. 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. gtag('js', new Date()); Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. Contraindications 2017;377:2240-2252. 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 Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Lightning 12 and Lightning 8 expand the already broad offering of CAT8, CATD, CAT6, CAT5, and CAT3 and are paired with Penumbra ENGINE, the company's proprietary continuous, mechanical vacuum . window.dataLayer = window.dataLayer || []; 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. 0, 24. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Do not resterilize or reuse. The CAT family of catheters is the foundation of Penumbra's Indigo system. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. o The Penumbra Indigo System Separator is intended for use with our Indigo System's family of catheters to enable the removal of a wide range of thrombus. Distal OD. PDF May 15, 2018 - Food And Drug Administration 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. Copyright 2022 Penumbra, Inc. All rights reserved. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. The INDIGO SEPARATOR is not intended for use as a guidewire. Maintain a constant infusion of appropriate flush solution. 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. Contraindications There are no known contraindications. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Do not use kinked or damaged devices. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. Chris Metzger, MD The patient underwent six shocks and was intubated while CAT RX was delivered through the freshly placed 3.5- X 38-mm DES to the PDA. Prior to use, please consult device labeling and instructions for use. 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. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. 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. Bradenton Cardiology Center/Manatee Memorial Hospital 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. Engineered with neuro-tracking technology, CAT RX is designed to navigate tortuous anatomy and track to distal coronary vasculature while maintaining sustained mechanical aspiration with the Penumbra ENGINE. 2023 Bryn Mawr Communications II, LLC. The CAT family of catheters is the foundation of Penumbra's Indigo System. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . chronic clot, atherosclerotic plaque) The cerebral vasculature Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Randomized trial of primary PCI with or without routine manual thrombectomy. function gtag(){dataLayer.push(arguments);} Vascular Thrombectomy. 2015;372:1389-1398. Indigo System - Vascupedia These pages are not intended for patients or for members of the general public. Penumbra's LANTERN Delivery Microcatheter integrates a highly trackable 2.6 F microcatheter with a high-flow lumen to facilitate confident delivery of Ruby Coil, POD, and Packing Coil even in tortuous anatomy. BJC Cardiology Throughout each case, Lightning provides procedural feedback via audio visual cues. 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. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . This content is not intended to offer professional medical advice. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . 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. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). suhail.dohad@cshs.org Interventional Cardiology Figure 3. Otherwise, this could result in degradation of the performance of this equipment. Do not use in oxygen rich environment. She was in a rehab facility prior to this new event recovering from her CVA. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. SciELO - Brasil - Suporte mecnico extracorpreo e trombectomia por Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Do not use kinked or damaged devices. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. The Indigo System and CAT8 - Endovascular Today 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. Aspiration or disruption of thrombus with traditional diminished syringe-based aspiration or other mechanical devices is difficult, often incomplete, and has been associated with high complication rates.1 Use of medical therapy, such as powerful anticoagulants and thrombolytics (ie, tissue plasminogen activator), may carry a high risk of bleeding.2 The Indigo System was designed to provide sustained aspiration with Penumbra ENGINE to effectively remove thrombus, while reducing the risk of bleeding complications.3 The Indigo System utilizes atraumatic catheters varying in diameters from 3.4 to 8 F and lengths ranging from 50 to 150 cm. Do not use in an oxygen rich environment. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. Device Name. Use prior to the Use By date. 1. The procedure can be performed quickly,1 which is important for symptomatic patients. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System.The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Contraindications Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. 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. Latest System Designed for Single Session Arterial Thrombus Removal News The means of mains disconnect is to remove the power cord. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). left-arrow . Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. Giri J, Sista AK, Weinberg J, et al. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. kolskiwellness@gmail.com This website is intended for US audience only. 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. 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 . Warnings/Precautions The canister is intended for single use only. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. The pain became more intense and constant, so he presented to the ED. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon.
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