cat8 penumbra catheter cat8 penumbra catheter

Do not resterilize or reuse. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. 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. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Use only waterbased solvents for cleaning. IN-DATE. CAT7 and CAT12 are the next generation of the Indigo System catheters. Jolly SS, Cairns JA, Lavi S, et al. 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 . Figure 1. 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. Copyright 2023 Penumbra, Inc. All rights reserved. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Separator 8, 150 cm Length, 0.072 in. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. Contraindications window.dataLayer = window.dataLayer || []; Return all damaged devices and packaging to the manufacturer/distributor. 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. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Copyright 2023 Penumbra, Inc. All rights reserved. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 Penumbra Aspiration Pump: 0 cm from the distal tip. . Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). The atraumatic tip and small catheter French size of the CAT8 device allows for easy tracking and maneuvering through the vasculature and selective debulking of thrombus from lobar branches of the pulmonary arterial tree. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. 2018;72:1589-1596. Figure 1. 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 safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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. These pages are not intended for patients or for members of the general public. Otherwise, this could result in degradation of the performance of this equipment. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Los Angeles, California Do not use in oxygen rich environment. 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. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Alameda, CA 94502. She was in a rehab facility prior to this new event recovering from her CVA. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. Maintain a constant infusion of appropriate flush solution. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. K180412. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. 2: Add Penumbra ENGINE Intended Use The atraumatic, low-profile design of CAT RX allowed for ease of deliverability through the freshly placed stent into the PDA when the patient was in critical condition. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. 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. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. 0, 24. Additional Details. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Related Items. Precautions 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. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). Do not use kinked or damaged devices. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. 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. 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. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. The product-specific content of this website is intended for use by healthcare professionals only. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. 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 . Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. window.dataLayer = window.dataLayer || []; The CAT family of catheters is the foundation of Penumbras Indigo System. Contraindications There are no contraindications. The CAT family of catheters is the foundation of Penumbra's Indigo system. After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. 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. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. TIMI 3 flow was achieved in 88% of cases. Do not use kinked or damaged devices. J Am Coll Cardiol. Do not resterilize or reuse. 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. 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. Mechanical power aspiration with the Indigo System CAT RX (Penumbra, Inc.), introduced in 2018, continues to gain in popularity as a solution for high thrombus burden in the coronaries. 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. The CAT family of catheters is the foundation of Penumbra's Indigo System. Return all damaged devices and packaging to the manufacturer/ distributor. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. 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. Otherwise, this could result in degradation of the performance of this equipment. Two passes of CAT RX with the Penumbra ENGINE resulted in TIMI 3 flow restoration and retrieval of the distal emboli from the PDA (Figure 3). Indigo System CAT RX tracking through the distal posterior tibial artery. 0, and 37. Do not re-infuse blood or fluid from the canister back into the patient. The cat8 was kinked approximately 69. 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. Worcester, Massachusetts 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. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . The treatment of arterial and venous thrombus is challenging. The results may vary depending on a variety of patient specific attributes. Cedars Sinai Medical Center Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Do not re-infuse blood or fluid from the canister back into the patient. Smidt Heart institute Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Categories. Final angiogram showing resolution of extensive thrombus burden. kolskiwellness@gmail.com Created with Sketch. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 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. Penumbra's not relying on software alone. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. 2019;140:e774-e801. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Control angiography immediately after thrombectomy demonstrated restored patency . Brandenton, Florida These pages are not intended for patients or for members of the general public. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). Initial angiography revealed an occlusion of the distal RCA. Initial angiogram showing high thrombus burden in the RCA. Device Name. Missouri Baptist Medical Center 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. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. Warnings 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: 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). 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. The Penumbra ENGINE addresses the limitations of traditional treatment options by providing sustained mechanical power aspiration for the duration of the procedure to help maximize efficiency of thrombus removal. This case illustrates the vast improvement in aspiration technology with an easy-to-deliver, trackable catheter that maintains sustained aspiration for the duration of the procedure. Relying on a different mechanism of action, power aspiration with CAT RX and Penumbra ENGINE was able to extract the thrombus intact; thus restoring flow through the graft. Maintain a constant infusion of appropriate flush solution. 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. The CAT family of catheters is the foundation of Penumbra's Indigo system. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Preprocedure TIMI 0 flow was seen in 76.3% of patients; TIMI 3 flow immediately post-CAT RX was demonstrated in 93.2% of patients. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. 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). This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. Disclosures: None. Bradenton Cardiology Center/Manatee Memorial Hospital Return all damaged devices and packaging to the manufacturer/distributor. 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. Do not resterilize or reuse. St. Joseph Hospital 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. PENUMBRA ENGINE Indication for Use Final angiogram after mechanical thrombectomy with CAT8 and SEP8. Figure 1. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. 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. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. To prevent fire or shock hazard, use a replacement power cord of equal rating. Figure 2. The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. Do not use kinked or damaged devices.