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After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. CAT RX is an essential tool in our percutaneous coronary armamentarium. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. 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. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Warnings Distal emboli causing PDA occlusion after manual aspiration. 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 use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The large aspiration lumen and highly trackable, low-profile design coupled with the power of the Penumbra ENGINE resulted in the successful removal of the emboli in one pass. 0, 26. Contraindications The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. 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. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . 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. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. The CAT family of catheters is the foundation of Penumbra's Indigo system. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Photo: Courtesy of Business Wire. UPC: Current Stock: This item is out of stock. 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. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arrhythmia; arteriovenous fistula; cardiac injury; cardio-respiratory arrest; death; device malfunction; distal embolization; emboli; excessive blood loss; 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; hemoptysis; respiratory failure; thromboembolic events. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. Figure 1. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Jolly SS, Cairns JA, Lavi S, et al. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Only use replacement fuse with correct rating (see Table 1 for fuse rating). There are no contraindications. 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. Penumbra's not relying on software alone. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. Do not resterilize or reuse. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Copyright 2023 Penumbra, Inc. All rights reserved. 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. Sista A. Indigo aspiration system for acute pulmonary embolism. 2023 Bryn Mawr Communications II, LLC. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. 8: Add BMK6F95M-NE . Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. 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 product-specific content of this website is intended for use by healthcare professionals only. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. Return all damaged devices and packaging to the manufacturer/distributor. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. . The CAT family of catheters is the foundation of Penumbra's Indigo System. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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 . The Indigo System Catheter CAT8 was used across 22 sites in the United States in patients with submassive PE who did not receive thrombolytics (98.3%), with a . S. Jay Mathews, MD, MS, FACC Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Contraindications Final angiographic result of SVG. 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 Lightning comes packaged with the Indigo CAT7 or CAT12. Figure 1. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 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. CAT7 and CAT12 are the next generation of the Indigo System catheters. Saxon RR, Benenati JF, Teigen C, et al. Do not use kinked or damaged devices. Do not reuse. The Indigo System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. 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 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. 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. $399.00 EACH. BJC Cardiology INDIGO Aspiration Tubing: Indication For Use The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Maintain a constant infusion of appropriate flush solution. Gus Theodos, MD, FACC, FSCAI Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. The product-specific content of this website is intended for use by healthcare professionals only. Figure 2. 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. 0, and 37. Contraindications Not for use in the coronaries or the neurovasculature. Penumbra Aspiration Pump: Do not use open or damaged packages. Available in a selection of sizes, the CAT family can provide access to distal peripheral . The means of mains disconnect is to remove the power cord. Figure 2. To prevent fire or shock hazard, use a replacement power cord of equal rating. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Otherwise, this could result in degradation of the performance of this equipment. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. She had acute tubular necrosis with minimal urine output at the time of transfer. Ultrasound-guided access was obtained through the right femoral vein. Vedantham S, Goldhaber SZ, Julian JA, et al. 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. Do not re-infuse blood or fluid from the canister back into the patient. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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; arteriovenous fistula; cardiac injury; cardio-respiratory arrest; death; device malfunction; distal embolization; emboli; excessive blood loss; 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; hemoptysis; respiratory failure; thromboembolic events. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. Worcester, Massachusetts Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy.
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