Indigo System CAT RX tracking through the distal posterior tibial artery. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). 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. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. The complaint has been evaluated. Copyright 2023 Penumbra, Inc. All rights reserved. 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. The CAT familyof catheters is the foundation of Penumbras Indigo System. 2018;29:92-100. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. If the cause cannot be determined, withdraw the device or system as a unit. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . 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. Return all damaged devices and packaging to the manufacturer/distributor. Throughout each case, Lightning provides procedural feedback via audio visual cues. Prior to use, please consult device labeling and instructions for use. BJC Cardiology 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. TIMI 3 flow was achieved in 88% of cases. Maintain a constant infusion of appropriate flush solution. The device is intended for single use only. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. The complaint indicated that the cat8 was kinked during the procedure. 2019;140:e774-e801. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Catheters & Separators. Randomized trial of primary PCI with or without routine manual thrombectomy. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Penumbra's Indigo Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Use prior to the Use By date. Contraindications A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. Do not resterilize or reuse. Lightning comes packaged with the Indigo CAT7 or CAT12. 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. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. 2015;372:1389-1398. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Figure 3. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. Figure 1. She was in a rehab facility prior to this new event recovering from her CVA. There were no cases of 30-day cardiovascular death or post procedural stroke. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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 pulmonary capillary wedge pressure is 10 mmHg. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. The Swan-Ganz catheter was exchanged over a long V18 wire. The procedure time was short (median of 37 minutes)the shortest demonstrated so far in an investigational device exemption (IDE) trial on patients with pulmonary embolism. 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. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. Final angiogram with complete TIMI 3 flow after the use of CAT RX. Contraindications There are no known contraindications. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Use prior to the Use By date. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. 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 kinked or damaged devices. 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 . Ultrasound-guided access was obtained through the right femoral vein. Orange, California 5 and 94. 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. 1. 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). The device is intended for single use only. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. 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. Precautions These types of burns heal withing 5 or 6 days without permanent scarring. 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). CAT RX is an essential tool in our percutaneous coronary armamentarium. Penumbra's high-performance aspiration catheters. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Penumbra, Inc. One Penumbra Place. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: 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. INDIGO Aspiration Tubing: 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. waqas.qureshi@umassmemorial.org 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. 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. J Vasc Interv Radiol. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. Circulation. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. gtag('js', new Date()); Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. Do not use open or damaged packages. 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).

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