cat8 penumbra catheter

Use prior to the Use By date. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Ballad CVA Heart & Vascular Institute function gtag(){dataLayer.push(arguments);} 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. Created with Sketch. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Order Qty. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. 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). Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . 1. 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. Throughout each case, Lightning provides procedural feedback via audio visual cues. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. 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 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. LIGHTNING Aspiration Tubing Indication for Use Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. If repositioning of the INDIGO Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard catheter and guidewire techniques. 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). Distal OD. gtag('js', new Date()); Indigo System CAT RX tracking through the distal posterior tibial artery. Vascular Thrombectomy. J Am Coll Cardiol. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Prior to use, please consult device labeling and instructions for use. Brandenton, Florida Potential Adverse Events 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. INDIGO Aspiration System Indication for Use Otherwise, this could result in degradation of the performance of this equipment. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. [email protected] The cerebral vasculature N Engl J Med. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. 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 complaint indicated that the cat8 was kinked during the procedure. Units in stock: 1. Penumbra, Inc. One Penumbra Place. Copyright 2022 Penumbra, Inc. All rights reserved. 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. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. 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. Ultrasound-guided access was obtained through the right femoral vein. This content is not intended to offer professional medical advice. Do not block bottom or back air vents. To prevent fire or shock hazard, use a replacement power cord of equal rating. Do not use open or damaged packages. Disclosures: Consultant to Penumbra, Inc. An 83-year-old woman transferred from an outside hospital presented with acute shortness of breath, was hypotensive, and was intubated. window.dataLayer = window.dataLayer || []; Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 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 . Aspiration Tubing Intended Use Do not reuse. These pages are not intended for patients or for members of the general public. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. [email protected]; @gtheodosmd Do not use in oxygen rich environment. Physicians in the USA have published details ofto their knowledgethe "first reported use" of the Indigo aspiration system (Penumbra) to treat cerebral venous sinus thrombosis (CVST) via endovascular thrombectomy.The treated patient underwent successful partial recanalisation of the superior sagittal sinus (SSS) and bilateral transverse sinuses (TS), and experienced . Figure 2. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). Do not use open or damaged packages. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The newly available Indigo CAT12 Aspiration Catheter (Penumbra, Inc.) was utilized to perform mechanical thrombectomy of the FV, CFV, and EIV and CIV without the use of thrombolytics . Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. 1. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Figure 1. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Contraindications Tareq Kass-Hout. Mathews SJ, Brown C, Kolski B, et al. Cedars Sinai Medical Center This website is intended for US audience only. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 Worcester, Massachusetts 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. 0, 23. CAT8XTORQ115KIT-NS. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. 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. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious . Sista A. Indigo aspiration system for acute pulmonary embolism. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. The INDIGO SEPARATOR is not intended for use as a guidewire. Copyright 2022 Penumbra, Inc. All rights reserved. Device Name. The patient remained on cangrelor with no need for tirofiban. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. Penumbra Aspiration Pump: 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. 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. Control angiography immediately after thrombectomy demonstrated restored patency . Waqas R. Qureshi, MD, MS It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. 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. No conversations found. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. Warnings Potential Adverse Events 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. 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. 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. Please email [email protected] or call us at 877-663-8686 and we will try to locate the product with our suppliers. 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. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Possible complications include, but are not limited to, the following: 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 5 and 94. The results may vary depending on a variety of patient specific attributes. The Penumbra CAT RX catheter was used in a total of 34 patients, with 71% STEMI, 23% NSTEMI, 3% UA, and 3% new onset heart failure. Lightning 7 expands Penumbra's offering of the Indigo Aspiration System with Intelligent Aspiration for mechanical thrombectomy and is designed for single session arterial thrombus removal. . The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. Mathews SJ, Brown C, Kolski B, et al. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. She had acute tubular necrosis with minimal urine output at the time of transfer. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Contraindications There are no contraindications. This press release features multimedia. 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. Distal posterior tibial artery emboli occlusion. [email protected] Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 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.

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