cat8 penumbra catheter cat8 penumbra catheter

Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. This is potentially more effective than diminished syringe-based aspiration. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. The system uses Penumbra's RED reperfusion catheters. Use only water-based solvents for cleaning. Prior to use, please consult device labeling and instructions for use. Do not resterilize or reuse. Do not use kinked or damaged devices. 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 . Do not resterilize or reuse. 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. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. Initial angiography revealed an occlusion of the distal RCA. Vascular Thrombectomy. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. The pulmonary capillary wedge pressure is 10 mmHg. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. All Rights Reserved Privacy Policy, 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; Suhail Dohad, MD, FACC. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Disclosures: Consultant to Penumbra, Inc. A 92-year-old man with a history of coronary artery disease (treated previously with coronary artery bypass graft) and severe aortic stenosis (treated previously with transcatheter aortic valve replacement) presented to the ED with chest pain. Do not use kinked or damaged devices. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. J Am Coll Cardiol. The CAT familyof catheters is the foundation of Penumbras Indigo System. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. INDIGO Aspiration System Indication for Use Contraindications There are no known contraindications. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. 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 . The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). 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. Enter your email address and we will contact you. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. K180412. Smidt Heart institute Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. This content is not intended to offer professional medical advice. It will reduce the service life of the PENUMBRA ENGINE. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. To prevent fire or shock hazard, use a replacement power cord of equal rating. 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. Figure 1. Penumbra's high-performance aspiration catheters. 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. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. There was partial improvement of flow, but total occlusion remained. Next Article Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. St. Joseph Hospital Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. window.dataLayer = window.dataLayer || []; Contraindications 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. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 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. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Precautions Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. suhail.dohad@cshs.org The procedure was completed with the same catheter. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. . This website is intended for US audience only. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. The Penumbra P logos, 3D, 3D Revascularization Device, ACE, BENCHMARK, CAT, Indigo, LANTERN, MAX, Neuron, Neuron MAX, Penumbra ENGINE, Penumbra JET, Penumbra System, Penumbra SMART COIL, POD, Ruby, Separator, Velocity, and WAVE are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. Do not reuse. Indigo Aspiration System Intended Use This is potentially more effective than diminished syringe-based aspiration. Potential Adverse Events 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. In patients with submassive pulmonary embolism with compromised right ventricular function and elevated biomarkers, the Indigo System is an excellent frontline tool offering a safe and effective1 treatment option. 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. 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. Penumbra ENGINE Intended Use N Engl J Med. 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. waqas.qureshi@umassmemorial.org If the cause cannot be determined, withdraw the device or system as a unit. 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. Warnings/Precautions The canister is intended for single use only. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. Control angiography immediately after thrombectomy demonstrated restored patency . Final angiogram with complete TIMI 3 flow after the use of CAT RX. 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. gtag('js', new Date()); Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Bradenton Cardiology Center/Manatee Memorial Hospital (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. 2023 Bryn Mawr Communications II, LLC. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. Otherwise, this could result in degradation of the performance of this equipment. After one pass with mechanical thrombectomy using CAT RX, the thrombus was removed and flow was restored to the pedal arch via the plantar posterior tibial artery (Figure 2 and Figure 3). Return all damaged devices and packaging to the manufacturer/distributor. The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum to our catheters to remove thrombus in vessels of various sizes. This press release features multimedia. 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. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. 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.