It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. IN-DATE. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. 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. Vascular Thrombectomy. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. These pages are not intended for patients or for members of the general public. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. 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 results may vary depending on a variety of patient specific attributes. kolskiwellness@gmail.com 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. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION Penumbra Aspiration Pump: Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). 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. Waqas R. Qureshi, MD, MS 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. Distal OD. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). 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. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. 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. Possible complications include, but are not limited to, the following: The complaint has been evaluated. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. Innovation in Coronary Mechanical Thrombectomy: Indigo System CAT RX Do not use open or damaged packages. The Indigo Aspiration System is contraindicated in: 8: Add BMK6F95M-NE . Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Do not reuse. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Penumbra Cat 8 - IndiaMART Maintain a constant infusion of appropriate flush solution. Penumbra, CAT8XTORQ115, Penumbra CAT8 Indigo Aspiration Catheter, XTorq The Indigo System CAT RX with Penumbra ENGINE is an invaluable tool that is easy to set up and can provide rapid thrombectomy and immediate reperfusion. Figure 1. There are no contraindications. Penumbra CAT6, Indigo system Aspiration Catheter 6F, 135cm - MedicalEcart Contraindications Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. Initial angiogram showing high thrombus burden in the RCA. Maintain a constant infusion of appropriate flush solution. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. J Am Coll Cardiol. Warnings/Precautions The canister is intended for single use only. Precautions The device is intended or single use only. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Contraindications The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Copyright 2023 Penumbra, Inc. All rights reserved. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 5, 21. The CAT family of catheters is the foundation of Penumbra's Indigo system. 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 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 sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. Indigo Aspiration System Intended Use 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. 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. Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Equipment is not safe for MR use. Kingsport, Tennessee Otherwise, this could result in degradation of the performance of this equipment. 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. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. 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. Penumbra ENGINE Intended Use The complaint indicated that the cat8 was kinked during the procedure. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. A Penumbra CAT8 catheter was placed into the right upper lobe, right middle lobe, and right lower lobe, and aspiration with a separator was performed. gtag('js', new Date()); The low-profile catheter and Penumbra ENGINE are easy to set up and use. Penumbra Recalls JET 7 Catheters with Xtra Flex -Risk of Mortality Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. 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. Indigo System Intended Use 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. 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. She had acute tubular necrosis with minimal urine output at the time of transfer. 2023 Bryn Mawr Communications II, LLC. 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. Mechanical clot engagement with proprietary Separator technology, Tip directionality for circumferential aspiration, The Indigo System is an integrated system for use only with other components of the Indigo System including the CAT family of catheters, Separators, Dynamic Aspiration Tubing, Lightning, Penumbra ENGINE, and Penumbra ENGINE Canister, Lightning Computer-Aided Aspiration comes packaged with CAT7 or CAT12, Live feedback during the procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. To prevent fire or shock hazard, use a replacement power cord of equal rating. Do not use kinked or damaged devices. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . waqas.qureshi@umassmemorial.org Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. CAT8XTORQ115KIT-NS.