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 . For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. suhail.dohad@cshs.org Do not use open or damaged packages. Penumbra aspiration assistance | Medical Billing and Coding Forum - AAPC 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. Rethinking Thrombus Removal With the Indigo System: Introducing 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. Figure 1. Only use replacement fuse with correct rating (see Table 1 for fuse rating). 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. This warranted the need for further innovation in the field of acute coronary syndrome.2 The goal of the Indigo System CAT RX mechanical aspiration system powered by the Penumbra ENGINE is to provide sustained aspiration for the duration of the procedure with enhanced deliverability to navigate tortuous anatomy and track to the distal coronary vasculature. Do not resterilize or reuse. 2. 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. Not for use in the coronaries or the neurovasculature. Jawairia Sahar K. Mirza, MBBS 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. There were no cases of 30-day cardiovascular death or post procedural stroke. The deliverability and continuous aspiration power were essential to achieving restoration of flow supporting a positive patient outcome to help heal this case of CLI. Interventional Cardiology 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 ENGINE Intended Use Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. 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 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. Maintain a constant infusion of appropriate flush solution. Precautions The device is intended for single use only. Use prior to the Use By date. SciELO - Brasil - Suporte mecnico extracorpreo e trombectomia por Indigo Separator 4 is intended to be used with Indigo CAT RX Aspiration Catheter to clear the distal end of the catheter lumen should it be blocked with thrombus. Warnings The product-specific content of this website is intended for use by healthcare professionals only. . Do not block bottom air vents. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. The CAT family of catheters is the foundation of Penumbra's Indigo system. The Indigo System and CAT8 - Endovascular Today N Engl J Med. Aspiration Tubing Intended Use Indigo Aspiration System Intended Use Do not use kinked or damaged devices. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). The CAT familyof catheters is the foundation of Penumbras Indigo System. Device Name. 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. CAT8XTORQ115KIT-NS. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Do not use kinked or damaged devices. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Additional Details. Otherwise, this could result in degradation of the performance of this equipment. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. 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. INDIGO Aspiration Catheters and Separators: 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. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. Applicant. The newest indication for the Indigo System is the treatment of pulmonary embolism; this indication comes on the heels of the promising results of the EXTRACT-PE trial. The removal of fibrous, adherent or calcified material (e.g. 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. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Figure 1. Do not use open or damaged packages. 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. 510(k) Premarket Notification - Food And Drug Administration The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. Ballad CVA Heart & Vascular Institute Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. 0, 26. Indigo System | Computer-Aided Mechanical Aspiration. The Penumbra Indigo System Separator is intended for use with our Indigo Systems CAT family of catheters to enable the removal of a wide range of thrombus. Contraindications Lightning comes packaged with the Indigo CAT7 or CAT12. 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. CAT7 and CAT12 are the next generation of the Indigo System Catheters. 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. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. N Engl J Med. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. 1. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. 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. (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. 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. Contraindications Not for use in the coronaries or the neurovasculature. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . To prevent fire or shock hazard, use a replacement power cord of equal rating. 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. 0 cm from the hub. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . Smidt Heart institute The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Order Qty. Maintain a constant infusion of appropriate flush solution. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. 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. If the cause cannot be determined, withdraw the device or system as a unit. Final angiogram after stent placement showing resolution of underlying disease. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. Penumbra Aspiration Pump: Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Throughout each case, Lightning provides procedural feedback via audio visual cues. 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. Mechanical Thrombectomy. Manual aspiration using a Pronto V3 (Teleflex) catheter restored some flow, however, distal embolization to the posterior descending artery (PDA) immediately caused right ventricular cardiac arrest (Figure 2). Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. CAT7 and CAT12 are the next generation of the Indigo System catheters. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. This press release features multimedia. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 2. IN-DATE. QUICK VIEW. As part of the Indigo Aspiration System, the Indigo Sterile Aspiration Tubing is indicated to connect the Indigo CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). The CAT8 is indicated for removal of emboli and thrombi from the peripheral . Mathews SJ, Brown C, Kolski B, et al. The procedure was completed with the same catheter. Figure 2. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. UMassMemorial University Campus Worcester, Massachusetts INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 Indication for 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. Copyright 2023 Penumbra, Inc. All rights reserved. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. 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. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. The patient remained on cangrelor with no need for tirofiban. Initial angiogram of the right pulmonary artery showing pulmonary embolism. The device is intended for single use only. To prevent fire or shock hazard, use a replacement power cord of equal rating. Penumbra Aspiration Pump: Penumbra, CAT8TORQ85, Penumbra CAT8 Indigo Aspiration Catheter, Torq The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The product-specific content of this website is intended for use by healthcare professionals only. The INDIGO SEPARATOR is not intended for use as a guidewire. 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. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Potential Adverse Events A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). Precautions The device is intended or single use only. St. Joseph Hospital The penumbra cat8 indigo system (cat8) was kinked approximately 4. S. Jay Mathews, MD, MS, FACC Orange, California Brandenton, Florida Figure 3. INDIGO Aspiration System Intended Use 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. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . 1. Penumbra Indigo Aspiration System IDE Trial for Acute Pulmonary Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. 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. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The canister is intended for single use only. 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 . After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. 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. PDF May 15, 2018 - Food And Drug Administration 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 . . 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. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Innovation in Coronary Mechanical Thrombectomy: Indigo System CAT RX The Indigo Aspiration System is contraindicated in: 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. Indication For Use 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Indigo System - Vascupedia INDIGO Aspiration System Intended Use 3. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. If the cause cannot be determined, withdraw the device or system as a unit. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. INDIGO Aspiration System Indication for Use The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. The means of mains disconnect is to remove the power cord. The product-specific content of this website is intended for use by healthcare professionals only. Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight The CAT family of catheters is the foundation of Penumbra's Indigo system. Warnings/Precautions 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. Initial angiogram showing high thrombus burden in the RCA. 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. 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. 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 the PENUMBRA ENGINE. Warnings 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. The CAT family of catheters is the foundation of Penumbras Indigo System. These data are encouraging and have led to the next stage in data collection through the CHEETAH studya 400-patient, prospective, observational study evaluating the initial safety and performance of the Indigo Aspiration System CAT RX. 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. The low-profile catheter and Penumbra . Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Do not use open or damaged packages. Do not use kinked or damaged devices. 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. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Medical Director, Aortic Disease and Ischemic Limb Disease It will reduce the service life of the PENUMBRA ENGINE. Disclosures: None. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. Penumbra CAT6, Indigo system Aspiration Catheter 6F, 135cm - MedicalEcart gtag('js', new Date()); Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. Figure 1. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Indigo System CAT RX tracking through the distal posterior tibial artery. Bradenton Cardiology Center/Manatee Memorial Hospital . The system uses Penumbra's RED reperfusion catheters. The CAT family of catheters is the foundation of Penumbra's Indigo System. BJC Cardiology The Indigo System CAT RX was the preferred choice for mechanical aspiration thrombectomy to remove the distal emboli below the knee in the posterior tibial artery. Director of Cardiac Catheterization Lab, PERT & Structural Heart Return all damaged devices and packaging to the manufacturer/distributor. System Chair, Clinical Research Do not reuse. sjaymathewsmd@gmail.com Figure 3. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. 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. chronic clot, atherosclerotic plaque) No conversations found. This is potentially more effective than diminished syringe-based aspiration. The pulmonary capillary wedge pressure is 10 mmHg. PENUMBRA: CAT6 - WestCMR 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.
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