These types of burns heal withing 5 or 6 days without permanent scarring. SVG occlusions can be challenging to resolve using traditional treatment modalities. The cat8 was kinked approximately 69. 1. 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. This warranted the need for further innovation in the field of acute coronary syndrome.2 The goal of the Indigo System CAT RX mechanical aspiration system powered by the Penumbra ENGINE is to provide sustained aspiration for the duration of the procedure with enhanced deliverability to navigate tortuous anatomy and track to the distal coronary vasculature. LIGHTNING Aspiration Tubing Indication for Use 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 . Interventional Cardiology Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. No modification of this equipment is allowed. Do not resterilize or reuse. The CAT family of catheters is the foundation of Penumbra's Indigo System. The pulmonary capillary wedge pressure is 10 mmHg. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. 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. Mathews SJ, Brown C, Kolski B, et al. 2019;140:e774-e801. Possible complications include, but are not limited to, the following: Do not use open or damaged packages. PENUMBRA ENGINE Indication for Use Use prior to the Use By date. 3D, 3D Revascularization Device, ACE, Artemis, BENCHMARK, CAT, Indigo, LANTERN, Lightning, MAX, Neuron, Neuron MAX, Penumbra Coil 400, Penumbra ENGINE, Penumbra P logos, Penumbra System, Penumbra SMART COIL, POD, PX SLIM, Ruby, Select, Separator, Velocity, and WAVE are all registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. Available in a selection of sizes, the CAT family can provide access to distal peripheral . If the cause cannot be determined, withdraw the device or system as a unit. This press release features multimedia. Do not use in oxygen rich environment. suhail.dohad@cshs.org gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. (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. The cerebral vasculature Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. N Engl J Med. The Indigo Aspiration System is comprised of several devices: The Indigo System may be used as a first-line approach or rescue therapy for arterial and venous thrombotic events. TIMI 3 flow was achieved in 88% of cases. System Chair, Clinical Research 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 canister is intended for single use only. She had acute tubular necrosis with minimal urine output at the time of transfer. 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. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. Contraindications There are no known contraindications. 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. Jawairia Sahar K. Mirza, MBBS Disclosures: Consultant to Penumbra, Inc. A 59-year-old man with a history of hypertension and tobacco use presented with an inferior-posterior acute myocardial infarction (MI). 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 . 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. Maintain a constant infusion of appropriate flush solution. Applicant. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Potential Adverse Events Do not resterilize or reuse. waqas.qureshi@umassmemorial.org The INDIGO SEPARATOR is not intended for use as a guidewire. 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. 1. Do not resterilize or reuse. The INDIGO SEPARATOR is not intended for use as a guidewire. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Do not use open or damaged packages. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . K180412. 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). . Next Article Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 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. Indication For Use Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. 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. Further evaluation of the returned device revealed kinks in the catheter shaft. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Distal posterior tibial artery emboli occlusion. Chris Metzger, MD 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. 2023 Bryn Mawr Communications II, LLC. Mechanical Thrombectomy. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Conclusions: evaluation of the cat8 revealed that the device was fractured. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Copyright 2022 Penumbra, Inc. All rights reserved. Final angiogram showing resolution of extensive thrombus burden. 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. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. University of Massachusetts Medical School Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. This website is intended for US audience only. Figure 2. This content is not intended to offer professional medical advice. This website is intended for US audience only. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. Figure 1. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. 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. 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. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. Warnings Categories. In a retrospective analysis of patients in our practice with fresh thrombus burden, we have observed TIMI 3 restored when using CAT RX frontline.1 This is another positive patient outcome with the use of CAT RX in a case of high thrombus burden. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. minimalism: a documentary about the important things transcript; cat8 penumbra catheter; i 75 road construction cincinnati; tocaya west hollywood; best places to live in alabama near the. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Penumbras IndigoAspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. Do not use in oxygen rich environment. After one pass with CAT RX, the initial occlusion was removed. Copyright 2023 Penumbra, Inc. All rights reserved. Randomized trial of primary PCI with or without routine manual thrombectomy. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. The product-specific content of this website is intended for use by healthcare professionals only. CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral . Figure 2. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. An Interview With Binita Shah, MD, MS, FACC, FSCAI, By Mansi Oberoi, MD; M. Chadi Alraies, MD; and Poonam Velagapudi, MD, MS, Left Main Disease and Bifurcation Revascularization in Female Patients, By Tara L. Jones, MD, PharmD, and Valeria Paradies, MD, By Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, Applying Team-Based Care Delivery to Interventional Cardiology: Learnings from the 2022 MedAxiom CV APP Survey, Understanding Sex Differences in Acute and Chronic Coronary Syndromes, By F. Aaysha Cader, MBBS, MD, MRCP(UK), MSc(Oxon); Rudaynah Amein Alali, MBBS, Internal Medicine Board, Interventional Cardiology Fellowship, RCPI; and Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, SuperSaturated Oxygen Therapy: Cases and Cocktails Event Winning Presentations, With Charishma Nallapati, MD; Amer N. Kadri, MD; James Richard Spears, MD; Zaid Al-Jebaje, MD; Babar Basir, DO; and Khaldoon Alaswad, MD, FACC, FSCAI. gtag('js', new Date()); It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. 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. The pain became more intense and constant, so he presented to the ED. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). Figure 1. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Figure 2. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. 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. Do not use open or damaged packages. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. BJC Cardiology Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. Units in stock: 1. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. The product-specific content of this website is intended for use by healthcare professionals only. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . The INDIGO Aspiration Tubing: chronic clot, atherosclerotic plaque) Disclosures: Consultant to Penumbra, Inc. A 92-year-old man with a history of coronary artery disease (treated previously with coronary artery bypass graft) and severe aortic stenosis (treated previously with transcatheter aortic valve replacement) presented to the ED with chest pain. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Worcester, Massachusetts The INDIGO SEPARATOR 4 is not intended for use as a guidewire. INDIGO Aspiration System Intended Use There are no contraindications. 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). Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. 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. 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. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 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. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. It will reduce the service life of the PENUMBRA ENGINE. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. 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. Precautions The device is intended for single use only. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. 3D, 3D Revascularization Device, ACE, Artemis, BENCHMARK, CAT, Indigo, LANTERN, Lightning, MAX, Neuron, Neuron MAX, Penumbra Coil 400, Penumbra ENGINE, Penumbra P logos, Penumbra System, Penumbra SMART COIL, POD, PX SLIM, Ruby, Select, Separator, Velocity, and WAVE are all registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . 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. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Orange, California 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. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Initial angiogram of the right pulmonary artery showing pulmonary embolism. Figure 2. Penumbra ENGINE Intended Use Potential Adverse Events Copyright 2023 Penumbra, Inc. All rights reserved. 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). Return all damaged devices and packaging to the manufacturer/distributor. She was in a rehab facility prior to this new event recovering from her CVA. Learn more about Lightning. These pages are not intended for patients or for members of the general public. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. Otherwise, this could result in degradation of the performance of this equipment. 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. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus.

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