Maintain a constant infusion of appropriate flush solution. Pinterest; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm Penumbra System) Model #: CAT8XTORQ115KIT OEM: Penumbra System Expiration Date: 2022 Size : 8Fr x 115cm . Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Prior to use, please consult device labeling and instructions for use. UMassMemorial University Campus Penumbra Aspiration Pump: PDF May 15, 2018 - Food And Drug Administration Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. gtag('js', new Date()); The product-specific content of this website is intended for use by healthcare professionals only. This website is intended for US audience only. Ballad CVA Heart & Vascular Institute Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. Penumbra Indigo System | Vascular Thrombectomy excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . The INDIGO SEPARATOR is not intended for use as a guidewire. Do not use kinked or damaged devices. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Missouri Baptist Medical Center Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). 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. Distal OD. Circulation. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Indication For Use St. Joseph Hospital Categories. Penumbra's CAT family of catheters is engineered to be robust, trackable, atraumatic, and well suited to the peripheral anatomy where clots can form in long segments. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Created with Sketch. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Figure 1. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. gtag('js', new Date()); 2. Only use replacement fuse with correct rating (see Table 1 for fuse rating). CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. 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. Return all damaged devices and packaging to the manufacturer/distributor. suhail.dohad@cshs.org Copyright 2023 Penumbra, Inc. All rights reserved. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Neuro | Penumbra, Inc. | Mechanical Thrombectomy & Embolization Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 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. No modification of this equipment is allowed. CAT7 and CAT12 are the next generation of the Indigo System Catheters. waqas.qureshi@umassmemorial.org Potential Adverse Events 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. Penumbra Aspiration Pump: Not for use in the coronaries or the neurovasculature. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Warnings Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. Conclusions: evaluation of the cat8 revealed that the device was fractured. Photo: Courtesy of Business Wire. Initial angiogram of the right pulmonary artery showing pulmonary embolism. . CAT7 and CAT12 are the next generation of the Indigo System catheters. Potential Adverse Events gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. 2019;140:e774-e801. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. Do not resterilize or reuse. Learn more about Lightning. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. Initial angiogram showing high thrombus burden in the RCA. Worcester, Massachusetts MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION 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. Penumbra's high-performance aspiration catheters. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Indigo System CAT RX tracking through the distal posterior tibial artery. Order Qty. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). This content is not intended to offer professional medical advice. Do not resterilize or reuse. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. The cerebral vasculature We presented our initial experience at the American College of Cardiologys (ACC) 68th Annual Scientific Session, which showed promising results for mechanical power aspiration for thrombus removal during percutaneous intervention using CAT RX.3 This retrospective case series included 59 patients from four institutions around the United States. CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. Warnings/Precautions The canister is intended for single use only. 1. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. 5, 19. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Do not use open or damaged packages. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. 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. 5, 21. Lightning comes packaged with the Indigo CAT7 or CAT12. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Mathews SJ, Brown C, Kolski B, et al. The results may vary depending on a variety of patient specific attributes. The treatment of arterial and venous thrombus is challenging. Do not resterilize or reuse. Do not block bottom air vents. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Use prior to the Use By date. Figure 2. Chris Metzger, MD Return all damaged devices and packaging to the manufacturer/distributor. Indigo System - Vascupedia Copyright 2022 Penumbra, Inc. All rights reserved. The Penumbra CAT RX catheter was used in a total of 34 patients, with 71% STEMI, 23% NSTEMI, 3% UA, and 3% new onset heart failure. Figure 2. Penumbra enrols first patient in CHEETAH Study of Indigo CAT RX device With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. INDIGO Aspiration Catheters and Separators: 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. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . . 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. 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. Final angiogram with complete TIMI 3 flow after the use of CAT RX. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. 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. 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 . Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. PENUMBRA: SEP8 - Westcmr.com 510(k) Premarket Notification - Food And Drug Administration The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. Bradenton Cardiology Center/Manatee Memorial Hospital Equipment is not safe for MR use. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. The Indigo System met its efficacy and safety endpoints by reducing right-to-left ventricle (RV/LV) ratio at 48 hours by 27.3% (mean ratio reduction, 0.43; 95% confidence interval, 0.380.47; P < .0001) and had a low major adverse event of 1.7% (2/119). 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). 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 the PENUMBRA ENGINE. System Chair, Clinical Research Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. 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. INDIGO Aspiration System Indication for Use 5 and 94. 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. 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. Copyright 2023 Penumbra, Inc. All rights reserved. Precautions INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Jolly SS, Cairns JA, Yusuf S, et al. In our practice, we have been able to more accurately define percutaneous transluminal coronary angioplasty and stent length as a result of this increased visualization. Potential Adverse Events The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 1. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. Prior to use, please consult device labeling and instructions for use. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. 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. window.dataLayer = window.dataLayer || []; PENUMBRA ENGINE Intended Use QUICK VIEW. Alameda, CA 94502. Jawairia Sahar K. Mirza, MBBS 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). The Penumbra P logos, 3D, 3D Revascularization Device, ACE, BENCHMARK, CAT, Indigo, LANTERN, MAX, Neuron, Neuron MAX, Penumbra ENGINE, Penumbra JET, Penumbra System, Penumbra SMART COIL, POD, Ruby, Separator, Velocity, and WAVE are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Brian Kolski, MD This website is intended for US audience only. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. The newest indication for the Indigo System is the treatment of pulmonary embolism; this indication comes on the heels of the promising results of the EXTRACT-PE trial. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Orange, California Return all damaged devices and packaging to the manufacturer/distributor. Saint Louis, Missouri Control angiography immediately after thrombectomy demonstrated restored patency . Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. 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. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. Figure 2. 3. chronic clot, atherosclerotic plaque) A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Innovation in Coronary Mechanical Thrombectomy: Indigo System CAT RX 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. Only use replacement fuse with correct rating (see Table 1 for fuse rating). The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Utility of a power aspiration-based extraction technique as an initial and secondary approach in the treatment of peripheral arterial thromboembolism: results of the multicenter PRISM Trial. Figure 2. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. Do not use in an oxygen rich environment. 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. The complaint indicated that the cat8 was kinked during the procedure. Director, Structural Heart Figure 1. Pela bainha, foi introduzido o dispositivo de aspirao Penumbra Indigo System CAT8 XTORQ (Penumbra Inc., Alameda, Califrnia, Estados Unidos) em trombo segmentar, lobar ou arterial pulmonar principal, sendo realizada aspirao contnua (Figuras 2 e 3). Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. window.dataLayer = window.dataLayer || []; left-arrow 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'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. 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. right-arrow Jolly SS, Cairns JA, Lavi S, et al. CAT RX is an essential tool in our percutaneous coronary armamentarium. Separator 8, 150 cm Length, 0.072 in. Figure 3. How Penumbra's smart-sucking algorithms and catheters speed up clot Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. function gtag(){dataLayer.push(arguments);} Initial angiography revealed an occlusion of the distal RCA. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. Lightning Flash: The Most Powerful and Advanced Mechanical 2. The removal of fibrous, adherent or calcified material (e.g. Indigo System | Penumbra Inc 3. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. Do not reuse. Indigo Aspiration System Intended Use Suhail Dohad, MD, FACC Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Potential Adverse Events Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. 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. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Penumbra Cat 8 - IndiaMART If the cause cannot be determined, withdraw the device or system as a unit. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 510 (k) Number. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. This site is protected by reCAPTCHA and the Google, 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 Intelligent Aspiration comes packaged with CAT7, CAT8 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. Flow through left circumflex artery post-CAT RX. 2018;72:1589-1596. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. 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). The Penumbra Indigo System Separator is intended for use with our Indigo Systems CAT family of catheters to enable the removal of a wide range of thrombus. PENUMBRA ENGINE Indication for Use Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System.

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