cat8 penumbra catheter

Do not block bottom or back air vents. Kingsport, Tennessee Penumbra Aspiration Pump: Do not block bottom air vents. Do not use in oxygen rich environment. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Disclosures: Consultant to Penumbra, Inc. A 75-year-old woman with a history of diabetes, hypertension, and dyslipidemia presented with Rutherford class 5 critical limb ischemia (CLI) due to a nonhealing ulcer. Saint Louis, Missouri Penumbra's Newest Generation of Indigo Aspiration System Receives FDA Conclusions: evaluation of the cat8 revealed that the device was fractured. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Throughout each case, Lightning provides procedural feedback via audiovisual cues. Vascular Thrombectomy. Final angiogram showing resolution of extensive thrombus burden. 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. Figure 1. The INDIGO Aspiration Tubing: 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. 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. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 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. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. Contraindications This is potentially more effective than diminished syringe-based aspiration. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Device Name. Figure 2. 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. Mechanical clot engagement with proprietary Separator technology, Tip directionality for circumferential aspiration, The Indigo System is an integrated system for use only with other components of the Indigo System including the CAT family of catheters, Separators, Dynamic Aspiration Tubing, Lightning, Penumbra ENGINE, and Penumbra ENGINE Canister, Lightning Computer-Aided Aspiration comes packaged with CAT7 or CAT12, Live feedback during the procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F(x) Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Use prior to the Use By date. 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). Vedantham S, Goldhaber SZ, Julian JA, et al. The CAT familyof catheters is the foundation of Penumbras Indigo System. Penumbra's high-performance aspiration catheters. 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. Penumbra's LANTERN Delivery Microcatheter integrates a highly trackable 2.6 F microcatheter with a high-flow lumen to facilitate confident delivery of Ruby Coil, POD, and Packing Coil even in tortuous anatomy. Indigo System | Computer-Aided Mechanical Aspiration. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 1.10 Summary of Non-Clinical Data As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Initial angiogram showing high thrombus burden in the left circumflex artery. These pages are not intended for patients or for members of the general public. The means of mains disconnect is to remove the power cord. 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. UPC: Current Stock: . Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. 510(k) Premarket Notification - Food And Drug Administration Order Qty. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. This website is intended for US audience only. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. 1. 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. $399.00 EACH. Mechanical power aspiration with a continuous vacuum source and large lumen aspiration catheter was first introduced in the neurovascular space when Penumbra revolutionized thrombus removal for acute ischemic stroke patients. There are no contraindications. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. TIMI 3 flow was achieved in 88% of cases. 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. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. 3D, 3D Revascularization Device, ACE, Artemis, BENCHMARK, CAT, Indigo, LANTERN, Lightning, MAX, Neuron, Neuron MAX, Penumbra Coil 400, Penumbra ENGINE, Penumbra P logos, Penumbra System, Penumbra SMART COIL, POD, PX SLIM, Ruby, Select, Separator, Velocity, and WAVE are all registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. J Am Coll Cardiol. INDIGO Aspiration Tubing: Do not use kinked or damaged devices. Use prior to the Use By date. Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. CAT7 and CAT12 are the next generation of the Indigo System Catheters. The device is intended for single use only. Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. Units in stock: 1. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Sista A. Indigo aspiration system for acute pulmonary embolism. Figure 3. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Equipment is not safe for MR use. Maintain a constant infusion of appropriate flush solution. Figure 1. Do not resterilize or reuse. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The removal of fibrous, adherent or calcified material (e.g. Return all damaged devices and packaging to the manufacturer/distributor. The Swan-Ganz catheter was exchanged over a long V18 wire. J Vasc Interv Radiol. This content is not intended to offer professional medical advice. As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. gtag('js', new Date()); Categories. Copyright 2023 Penumbra, Inc. All rights reserved. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 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. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. PENUMBRA ENGINE Indication for Use 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. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. This site is protected by reCAPTCHA and the Google, Mechanical clot engagement with proprietary Separator technology, Tip directionality for circumferential aspiration, The Indigo System is an integrated system for use only with other components of the Indigo System including the CAT family of catheters, Separators, Dynamic Aspiration Tubing, Lightning, Penumbra ENGINE, and Penumbra ENGINE Canister, Lightning Intelligent Aspiration comes packaged with CAT7, CAT8 or CAT12, Live feedback during the procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. The treatment of arterial and venous thrombus is challenging. Director, Structural Heart Control angiography immediately after thrombectomy demonstrated restored patency . Mechanical Power Aspiration With the Indigo - Endovascular Today 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. . Equipment is not safe for MR 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. These pages are not intended for patients or for members of the general public. 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. Potential Adverse Events 1. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. SVG occlusions can be challenging to resolve using traditional treatment modalities. Return all damaged devices and packaging to the manufacturer/ distributor. Circulation. 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. An Interview With Binita Shah, MD, MS, FACC, FSCAI, By Mansi Oberoi, MD; M. Chadi Alraies, MD; and Poonam Velagapudi, MD, MS, Left Main Disease and Bifurcation Revascularization in Female Patients, By Tara L. Jones, MD, PharmD, and Valeria Paradies, MD, By Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, Applying Team-Based Care Delivery to Interventional Cardiology: Learnings from the 2022 MedAxiom CV APP Survey, Understanding Sex Differences in Acute and Chronic Coronary Syndromes, By F. Aaysha Cader, MBBS, MD, MRCP(UK), MSc(Oxon); Rudaynah Amein Alali, MBBS, Internal Medicine Board, Interventional Cardiology Fellowship, RCPI; and Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, SuperSaturated Oxygen Therapy: Cases and Cocktails Event Winning Presentations, With Charishma Nallapati, MD; Amer N. Kadri, MD; James Richard Spears, MD; Zaid Al-Jebaje, MD; Babar Basir, DO; and Khaldoon Alaswad, MD, FACC, FSCAI. The CAT family of catheters is the foundation of Penumbra's Indigo System. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Penumbras IndigoAspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Maintain a constant infusion of appropriate flush solution. window.dataLayer = window.dataLayer || []; The device is intended for single use only. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. 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). Lightning Flash: The Most Powerful and Advanced Mechanical US physicians publish "first reported use" of Indigo aspiration system Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. The pulmonary capillary wedge pressure is 10 mmHg. Do not use in an oxygen rich environment. Mechanical Thrombectomy. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. gtag('js', new Date()); The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. Potential Adverse Events Jawairia Sahar K. Mirza, MBBS The Indigo System and CAT8 - Endovascular Today The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. 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 . The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Indigo System - Vascupedia Photo: Courtesy of Business Wire. Indigo Aspiration System Intended Use waqas.qureshi@umassmemorial.org Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Do not resterilize or reuse. Missouri Baptist Medical Center There were no cases of 30-day cardiovascular death or post procedural stroke. Indication For Use The product-specific content of this website is intended for use by healthcare professionals only. University of Massachusetts Medical School Use prior to the Use By date. Initial angiogram of the right pulmonary artery showing pulmonary embolism. Contraindications There are no contraindications. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Disclosures: None. 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. 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. PENUMBRA: SEP8 - Westcmr.com The INDIGO SEPARATOR is not intended for use as a guidewire. PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8 DXE: Back to Search Results: Model Number CAT8XTORQ115KIT-S: Device Problems Break (1069); Physical Resistance/Sticking (4012) Patient Problem No Clinical Signs, Symptoms or Conditions (4582) Event Date 05/19/2021: Do not use open or damaged packages. Figure 1. Chris Metzger, MD Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. The procedure was completed with the same catheter. The penumbra cat8 indigo system (cat8) was kinked approximately 4. 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 .

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