The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. function gtag(){dataLayer.push(arguments);} Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. 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. Copyright 2022 Penumbra, Inc. All rights reserved. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. Penumbra ENGINE Intended Use gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. The deliverability and continuous aspiration power were essential to achieving restoration of flow supporting a positive patient outcome to help heal this case of CLI. Latest System Designed for Single Session Arterial Thrombus Removal News 2018;72:1589-1596. 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. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Figure 2. 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. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. 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. Return all damaged devices and packaging to the manufacturer/distributor. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. Otherwise, this could result in degradation of the performance of this equipment. 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; 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. 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. The canister is intended for single use only. Mechanical Thrombectomy. It will reduce service life of the Penumbra ENGINE. 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. 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. 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. Learn more about Lightning. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. St. Joseph Hospital CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. These pages are not intended for patients or for members of the general public. Copyright 2022 Penumbra, Inc. All rights reserved. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Precautions The device is intended or single use only. Return all damaged devices and packaging to the manufacturer/distributor. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 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. 5, 21. Missouri Baptist Medical Center 0, 23. 2. 2018;29:92-100. This website is intended for US audience only. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. 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. 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. Do not reuse. 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. There are no contraindications. Do not use kinked or damaged devices. Return all damaged devices and packaging to the manufacturer/distributor. To prevent fire or shock hazard, use a replacement power cord of equal rating. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Flow through left circumflex artery post-CAT RX. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Waqas R. Qureshi, MD, MS Indigo System | Computer-Aided Mechanical Aspiration. Available in a selection of sizes, the CAT family can provide access to distal peripheral . Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. right-arrow Do not use in oxygen rich environment. The pulmonary capillary wedge pressure is 10 mmHg. Penumbra's not relying on software alone. 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. 2. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 2: Add 2017;377:2240-2252. (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. Final angiogram after stent placement showing resolution of underlying disease. The patient received a 3.5- X 38-mm everolimus-eluting stent (Synergy drug-eluting stent [DES], Boston Scientific Corporation) with postdilation optimized by intravascular ultrasound (IVUS) and was then sent to the step-down unit. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. No modification of this equipment is allowed. Units in stock: 1. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. Do not reuse. Learn more about Lightning. Figure 3. 2023 Bryn Mawr Communications II, LLC. Do not use kinked or damaged devices. 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. Indigo Aspiration System Intended Use Director of Cardiac Catheterization Lab, PERT & Structural Heart Do not resterilize or reuse. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Penumbra Aspiration Pump: If the cause cannot be determined, withdraw the device or system as a unit. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. 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. Potential Adverse Events 5 and 94. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Randomized trial of primary PCI with or without routine manual thrombectomy. Director of Cardiac & Peripheral Cath Lab A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. Further evaluation of the returned device revealed kinks in the catheter shaft. INDIGO System LIGHTNING Aspiration Tubing Intended Use Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Potential Adverse Events 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. Use only waterbased solvents for cleaning. The procedure can be performed quickly,1 which is important for symptomatic patients. 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. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Do not use open or damaged packages. All Rights Reserved Privacy Policy, 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; Suhail Dohad, MD, FACC. 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. Distal emboli causing PDA occlusion after manual aspiration. 0, 24. Copyright 2022 Penumbra, Inc. All rights reserved. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. There was partial improvement of flow, but total occlusion remained. Medical Director, Aortic Disease and Ischemic Limb Disease These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015.