Indigo System Catheters & Separators | Penumbra Inc 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. The Indigo Separator 4 is not intended for use as a guidewire. The Indigo System and CAT8 - Endovascular Today The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 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). 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. Penumbra CAT6, Indigo system Aspiration Catheter 6F, 135cm - MedicalEcart Do not use in an oxygen rich environment. Do not resterilize or reuse. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . We expect the results to further refine and improve our technique for mechanical aspiration and fine-tune the use of CAT RX for patients with high thrombus burden. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Saint Louis, Missouri Aspiration Tubing Intended Use 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. Gus Theodos, MD, FACC, FSCAI Created with Sketch. Warnings Warnings/Precautions 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. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. window.dataLayer = window.dataLayer || []; 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: Penumbra enrols first patient in CHEETAH Study of Indigo CAT RX device Smidt Heart institute Do not resterilize or reuse. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. 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. Do not block bottom or back air vents. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Warnings gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. The CAT family of catheters is the foundation of Penumbra's Indigo System. SciELO - Brasil - Suporte mecnico extracorpreo e trombectomia por Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. 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. Indication For Use 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 System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. The procedure can be performed quickly,1 which is important for symptomatic patients. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 0, and 37. Latest System Designed for Single Session Arterial Thrombus Removal News Do not reuse. N Engl J Med. 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 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. 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. Further evaluation of the returned device revealed kinks in the catheter shaft. N Engl J Med. 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. Do not resterilize or reuse. Potential Adverse Events 0 cm from the hub. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Categories. Penumbra Indigo System | Vascular Thrombectomy Final angiogram showing resolution of extensive thrombus burden. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Return all damaged devices and packaging to the manufacturer/distributor. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. chronic clot, atherosclerotic plaque) 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. University of Massachusetts Medical School 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. After one pass with CAT RX, the initial occlusion was removed. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Flow through left circumflex artery post-CAT RX. J Am Coll Cardiol. The means of mains disconnect is to remove the power cord. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. These pages are not intended for patients or for members of the general public. Initial angiogram showing high thrombus burden in the RCA. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. 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. A, Penumbra Indigo System Continuous Aspiration - ResearchGate Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Indigo System CAT RX tracking through the distal posterior tibial artery. With a maximised inner diameter of 0.08 (2.1 mm) and a 7 French (2.3 mm) outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. Mechanical Thrombectomy | Medical Billing and Coding Forum - AAPC Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Do not use open or damaged packages. Mechanical Power Aspiration With the Indigo - Endovascular Today 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. The CAT family of catheters is the foundation of Penumbra's Indigo system. Otherwise, this could result in degradation of the performance of this equipment. Use prior to the Use By date. Do not use in oxygen rich environment. Initial angiogram showing high thrombus burden in the left circumflex artery. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Penumbra Announces U.S. Commercial Availability of INDIGO System Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). Copyright 2023 Penumbra, Inc. All rights reserved. The patient underwent six shocks and was intubated while CAT RX was delivered through the freshly placed 3.5- X 38-mm DES to the PDA. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. Potential Adverse Events 2018;29:92-100. There was partial improvement of flow, but total occlusion remained. The following case reports highlight CAT RX in a multitude of unique applications as a primary frontline device to treat patients with high thrombus burden. 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. Figure 2. Precautions The device is intended or single use only. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. INDIGO Aspiration Tubing: 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 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. Otherwise, this could result in degradation of the performance of this equipment. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Conclusions: evaluation of the cat8 revealed that the device was fractured. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30 cm) to any part of LIGHTNING Aspiration Tubing. 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. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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. INDIGO Aspiration System Intended Use 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. Do not use in an oxygen rich environment. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. gus.theodos@bjc.org; @gtheodosmd CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. Worcester, Massachusetts Indigo Disposable Separator 8, 150 cm Length, 0.072 in. The INDIGO Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems and certain central circulatory system conditions such as pulmonary emboli using continuous aspiration. Figure 2. The Indigo Aspiration System is comprised of several devices: The Indigo System is used as a first-line approach or rescue therapy for arterial and venous thrombotic events. gtag('js', new Date()); SVG occlusions can be challenging to resolve using traditional treatment modalities. The means of mains disconnect is to remove the power cord. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . 22. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. Suhail Dohad, MD, FACC Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. K180412. It will reduce service life of the Penumbra ENGINE. Potential Adverse Events 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. 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. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Photo: Courtesy of Business Wire. Copyright 2022 Penumbra, Inc. All rights reserved. function gtag(){dataLayer.push(arguments);} CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Contraindications There are no known contraindications. Do not use kinked or damaged devices. Tareq Kass-Hout. INDIGO Aspiration Catheters and Separators: Do not use in oxygen rich environment. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 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. 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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