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It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. 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. The CAT family of catheters is the foundation of Penumbras Indigo System. 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. Precautions The device is intended for single use only. After one pass with CAT RX, the initial occlusion was removed. Only use replacement fuse with correct rating (see Table 1 for fuse rating). 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. Separator 8, 150 cm Length, 0.072 in. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. 5, 19. 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. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. S. Jay Mathews, MD, MS, FACC CAT7 and CAT12 are the next generation of the Indigo System catheters. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Do not block bottom or back air vents. N Engl J Med. Figure 3. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 (Penumbra, Inc.) are indicated for the removal of fresh soft emboli and thrombi from vessels in the coronary and peripheral vasculature. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. Do not resterilize or reuse. Figure 2. Distal OD. System Chair, Clinical Research 2015;372:1389-1398. 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. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. INDIGO System LIGHTNING Aspiration Tubing Intended Use St. Joseph Hospital If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. K180412. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Warnings The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Do not use in an oxygen rich environment. function gtag(){dataLayer.push(arguments);} 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. It will reduce the service life of the PENUMBRA ENGINE. Equipment is not safe for MR use. 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. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. 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. 1.10 Summary of Non-Clinical Data As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a 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. 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. Precautions The device is intended for single use only. 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. 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. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Final angiogram after stent placement showing resolution of underlying disease. Enter your email address and we will contact you. Warnings 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. Sista A. Indigo aspiration system for acute pulmonary embolism. Power aspiration with CAT RX has allowed us to successfully remove thrombus in patients presenting with acute coronary syndrome, establishing quick distal reperfusion and also visualization of the underlying stenosis. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . The patient remained on cangrelor with no need for tirofiban. Otherwise, this could result in degradation of the performance of this equipment. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The INDIGO Aspiration System 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. The product-specific content of this website is intended for use by healthcare professionals only. If the cause cannot be determined, withdraw the device or system as a unit. These pages are not intended for patients or for members of the general public. Possible complications include, but are not limited to, the following: gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Maintain a constant infusion of appropriate flush solution. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The atraumatic, low-profile design of CAT RX allowed for ease of deliverability through the freshly placed stent into the PDA when the patient was in critical condition. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. Figure 1. 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. gtag('js', new Date()); The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. Gus Theodos, MD, FACC, FSCAI Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 The low-profile catheter and Penumbra . Do not use kinked or damaged devices. After IVUS, the stent was dilated to 3.75 mm. Do not use open or damaged packages. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. 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 open or damaged packages. 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 . Warnings/Precautions Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 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, durable, and trackable for use in the peripheral anatomy. 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. The Indigo System utilises the Penumbra ENGINE aspiration 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. Orange, California Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. 3. Indication For Use Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. 2. This content is not intended to offer professional medical advice. 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. 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. Warnings/Precautions The canister is intended for single use only. Indication For Use Do not use kinked or damaged devices. 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. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. 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. The low-profile catheter and Penumbra ENGINE are easy to set up and use. After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Randomized trial of primary PCI with or without routine manual thrombectomy. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. UPC: Current Stock: . The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . The results may vary depending on a variety of patient specific attributes. Do not reuse. Copyright 2022 Penumbra, Inc. All rights reserved. Photo: Courtesy of Business Wire. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. Penumbra's not relying on software alone. The Indigo Aspiration System is contraindicated in: Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. Use only waterbased solvents for cleaning. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. The complaint has been evaluated. 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. 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. 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. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. This is potentially more effective than diminished syringe-based aspiration. Initial angiogram showing high thrombus burden in the left circumflex artery. 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. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. 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. The device is intended for single use only. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. INDIGO Aspiration System Indication for Use Use prior to the Use By date. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Final angiogram with complete TIMI 3 flow after the use of CAT RX. Interventional Cardiology Use prior to the Use By date. 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). The Indigo System aspiration catheters are available in a range of lengths and diameters that, when connected to the Penumbra ENGINE pump, can atraumatically remove the thrombus present in various peripheral vascular beds. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Contraindications Director of Cardiac & Peripheral Cath Lab The complaint indicated that the cat8 was kinked during the procedure. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). Prior to use, please consult device labeling and instructions for use. 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. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Categories. 5 and 94. suhail.dohad@cshs.org Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. 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. Jolly SS, Cairns JA, Yusuf S, et al. 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. Use prior to the Use By date. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1).

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