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Lightning comes packaged with the Indigo CAT7 or CAT12. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. Warnings/Precautions PENUMBRA: CAT3 - westcmr.com This is potentially more effective than diminished syringe-based aspiration. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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. Distal OD, Sterile, Single-Use, Disposable, For CAT8 Penumbra Devices, Indigo Aspiration Catheters, Removal of Fresh, Soft Emboli and Thrombi from Vessels of Peripheral Arterial and Venous Systems The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. S. Jay Mathews, MD, MS, FACC 0, 24. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. The Indigo Aspiration System is contraindicated in: Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Indigo System Catheters & Separators | Penumbra Inc Due to our experience in such cases, sustained aspiration with the Indigo System CAT RX with Penumbra ENGINE has quickly become our frontline device, challenging the traditional method of manual aspiration in patients with thrombi and emboli in the coronary arteries. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. Catheters - Aspiration Catheters - Page 1 - Medical Materials 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. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. Penumbras IndigoAspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Figure 2. Using the usual telescoping technique of the sheath, the CAT8 and SEP8 were used in tandem to aspirate the thrombus using sustained aspiration with Penumbra ENGINE. 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. The treatment of arterial and venous thrombus is challenging. Do not use in oxygen rich environment. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Final angiogram showing resolution of extensive thrombus burden. Potential Adverse Events Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. The canister is intended for single use only. Indigo System CAT RX tracking through the distal posterior tibial artery. Thrombectomy & Embolization | Vascular Medical Devices - Penumbra Inc Photo: Courtesy of Business Wire. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Maintain a constant infusion of appropriate flush solution. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. Worcester, Massachusetts Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Contraindications There are no contraindications. No conversations found. Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. 0, 26. 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. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. 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. Do not use open or damaged packages. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. 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, Inc. One Penumbra Place. The means of mains disconnect is to remove the power cord. Relying on a different mechanism of action, power aspiration with CAT RX and Penumbra ENGINE was able to extract the thrombus intact; thus restoring flow through the graft. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Do not re-infuse blood or fluid from the canister back into the patient. This website is intended for US audience only. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . 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. Separator 8, 150 cm Length, 0.072 in. Penumbra ENGINE Indication For Use 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 open or damaged packages. INDIGO Aspiration Catheters and Separators: 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. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. Do not use kinked or damaged devices. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Equipment is not safe for MR use. Do not re-infuse blood or fluid from the canister back into the patient. Missouri Baptist Medical Center Do not use kinked or damaged devices. 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. Penumbra ENGINE Intended Use The pain became more intense and constant, so he presented to the ED. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. The cerebral vasculature Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . 3. Placing guidewire too distal in the pulmonary vasculature or excessive manipulation of aspiration/guiding catheter in the smaller, peripheral, and segmental pulmonary artery branches can result in vessel perforation. Manual aspiration suffers from diminished aspiration force as fluid fills in the syringe, potentially resulting in systemic embolization during catheter removal, as shown in the TOTAL trial published in 2015 (Figure 1).1 Subgroup analysis of patients with high thrombus burden was explored that highlighted the potential for improved outcomes. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Use prior to the Use By date. Kingsport, Tennessee 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). Do not use kinked or damaged devices. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION 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). Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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. CAT7 and CAT12 are the next generation of the Indigo System Catheters. Maintain a constant infusion of appropriate flush solution. Director, Structural Heart If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. The cat8 was kinked approximately 69. There are no contraindications. The INDIGO Aspiration Tubing: When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Potential Adverse Events When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. 1. SciELO - Brasil - Suporte mecnico extracorpreo e trombectomia por 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. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 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. The low-profile catheter and Penumbra ENGINE are easy to set up and use. Chris Metzger, MD Manual aspiration using a Pronto V3 (Teleflex) catheter restored some flow, however, distal embolization to the posterior descending artery (PDA) immediately caused right ventricular cardiac arrest (Figure 2). No modification of this equipment is allowed. Giri J, Sista AK, Weinberg J, et al. This website is intended for US audience only. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Penumbra Indigo System | Vascular Thrombectomy This content is not intended to offer professional medical advice. Do not reuse. She was in a rehab facility prior to this new event recovering from her CVA. 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. gus.theodos@bjc.org; @gtheodosmd Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Final angiographic result of SVG. Created with Sketch. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Ultrasound-guided access was obtained through the right femoral vein. Interventional Cardiology Do not use open or damaged packages. 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. Waqas R. Qureshi, MD, MS chronic clot, atherosclerotic plaque) The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Next Article 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. 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. US physicians publish "first reported use" of Indigo aspiration system The Penumbra ENGINE addresses the limitations of traditional treatment options by providing sustained mechanical power aspiration for the duration of the procedure to help maximize efficiency of thrombus removal. Figure 3. 2: Add Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight Applicant. The pulmonary capillary wedge pressure is 10 mmHg. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. 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. She had acute tubular necrosis with minimal urine output at the time of transfer. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Director of Cardiac & Peripheral Cath Lab indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Possible complications include, but are not limited to, the following: A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. window.dataLayer = window.dataLayer || []; Equipment is not safe for MR use. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. 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 . N Engl J Med. Do not use open or damaged packages. Potential Adverse Events Figure 2. 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.