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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. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Do not reuse. 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). 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. 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. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). Possible complications include, but are not limited to, the following: The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The CAT family of catheters is the foundation of Penumbra's Indigo system. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . 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. 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 use open or damaged packages. University of Massachusetts Medical School chronic clot, atherosclerotic plaque) Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. (CAT3, CAT RX, CAT5, CAT6, CAT8, and CATD) and patented Separator technology, which maintains continuous aspiration and helps limit clogging of the catheters tip during the procedure. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 0, 23. Otherwise, this could result in degradation of the performance of this equipment. 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 SEPARATOR is not intended for use as a guidewire. Use prior to the Use By date. 2015;372:1389-1398. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Figure 1. Lightning 12 and Lightning 8 expand the already broad offering of CAT8, CATD, CAT6, CAT5, and CAT3 and are paired with Penumbra ENGINE, the company's proprietary continuous, mechanical vacuum . CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. Disclosures: None. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. 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. 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. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . The Indigo Separator 4 is not intended for use as a guidewire. 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. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. 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. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 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. 2. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. Director, Structural Heart Do not use open or damaged packages. Figure 2. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Penumbra ENGINE. Saxon RR, Benenati JF, Teigen C, et al. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Do not use in an oxygen rich environment. N Engl J Med. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The Swan-Ganz catheter was exchanged over a long V18 wire. . Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Do not use kinked or damaged devices. 1. SVG occlusions can be challenging to resolve using traditional treatment modalities. 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. To prevent fire or shock hazard, use a replacement power cord of equal rating. K180412. 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 . Lightning comes packaged with the Indigo CAT7 or CAT12. Do not use kinked or damaged devices. After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. Copyright 2022 Penumbra, Inc. All rights reserved. Indigo Aspiration System Intended 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. 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. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Final angiographic result of SVG. Penumbra Cat 8 - IndiaMART Maintain a constant infusion of appropriate flush solution. Distal posterior tibial artery emboli occlusion. To prevent fire or shock hazard, use a replacement power cord of equal rating. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Equipment is not safe for MR use. This is potentially more effective than diminished syringe-based aspiration. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. 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. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. 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. Prior to use, please consult device labeling and instructions for use. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. sjaymathewsmd@gmail.com The device is intended for single use only. PDF May 15, 2018 - Food And Drug Administration These pages are not intended for patients or for members of the general public. 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. UPC: Current Stock: . Missouri Baptist Medical Center Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 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. This content is not intended to offer professional medical advice. The results may vary depending on a variety of patient specific attributes. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Director of Cardiac Catheterization Lab, PERT & Structural Heart Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Penumbra Recalls JET 7 Catheters with Xtra Flex -Risk of Mortality The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. Rethinking Thrombus Removal With the Indigo System: Introducing Penumbra ENGINE Intended Use Control angiography immediately after thrombectomy demonstrated restored patency .

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