Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. 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. Final angiogram after stent placement showing resolution of underlying disease. Penumbra Aspiration Pump: Potential Adverse Events The device is intended for single use only. Potential Adverse Events Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Return all damaged devices and packaging to the manufacturer/distributor. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. 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. 510(k) Premarket Notification - Food And Drug Administration Contraindications Distal OD. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Figure 2. Categories. 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. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 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. IN-DATE. Distal OD, Sterile, Single-Use, Disposable, For CAT8 Penumbra Devices, Indigo Aspiration Catheters, Removal of Fresh, Soft Emboli and Thrombi from Vessels of Peripheral Arterial and Venous Systems Potential Adverse Events Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Catheters & Separators. 2018;72:1589-1596. Do not resterilize or reuse. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. The device is intended for single use only. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. 2023 Bryn Mawr Communications II, LLC. Indigo System - Vascupedia Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. This website is intended for US audience only. Precautions The device is intended or single use only. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. 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 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. Penumbra Augments Vascular Franchise with Latest Indigo System Launch Distal posterior tibial artery emboli occlusion. INDIGO Aspiration System Indication for Use 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: 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. 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. Indigo System Intended Use Only use replacement fuse with correct rating (see Table 1 for fuse rating). 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. Penumbra, Inc. One Penumbra Place. The low-profile catheter and Penumbra . Learn more about Lightning. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. The device is intended for single use only. 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. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. 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. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. INDIGO Aspiration Catheters and Separators: Worcester, Massachusetts window.dataLayer = window.dataLayer || []; In 2014, Penumbra broke into the peripheral thrombectomy space with the release of the first Indigo System catheters, the 5-F CAT5 catheter and the 3-F CAT3 catheter (Penumbra, Inc.). N Engl J Med. This press release features multimedia. Initial angiography revealed an occlusion of the distal RCA. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. Created with Sketch. This is potentially more effective than diminished syringe-based aspiration. Prior to use, please consult device labeling and instructions for use. Use prior to the Use By date. The system uses Penumbra's RED reperfusion catheters. 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. In a retrospective analysis of patients in our practice with fresh thrombus burden, we have observed TIMI 3 restored when using CAT RX frontline.1 This is another positive patient outcome with the use of CAT RX in a case of high thrombus burden. 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. Penumbra's high-performance aspiration catheters. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 2: Add gtag('js', new Date()); The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). 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. 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. The treatment of arterial and venous thrombus is challenging. Available in a selection of sizes, the CAT family can provide access to distal peripheral . Maintain a constant infusion of appropriate flush solution. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). 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). 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. Penumbra ENGINE Intended Use MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 Suhail Dohad, MD, FACC 0 cm from the hub. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. Penumbra aspiration assistance | Medical Billing and Coding Forum - AAPC Vedantham S, Goldhaber SZ, Julian JA, et al. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. J Am Coll Cardiol. 2015;372:1389-1398. 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. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. 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 . Use prior to the Use By date. She was in a rehab facility prior to this new event recovering from her CVA. 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. Figure 1. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. 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). Alameda, CA 94502. 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. Kingsport, Tennessee Indigo System | Penumbra Inc The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. 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. chronic clot, atherosclerotic plaque) The cerebral vasculature Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. To prevent fire or shock hazard, use a replacement power cord of equal rating. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Warnings/Precautions Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Copyright 2023 Penumbra, Inc. All rights reserved. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Penumbra, a US-based provider of advanced therapies, has enrolled the first patient into the CHEETAH clinical study, designed to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. Penumbra ENGINE Indication For Use These pages are not intended for patients or for members of the general public. Circulation. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. A 65-cm 8-F Destination sheath (Terumo Interventional Systems) was advanced into the right pulmonary artery, first over a telescoping balloon tip catheter and stiff angle Glidewire (Terumo Interventional Systems). Final angiographic result of SVG. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Disclosures: None. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 1. Copyright 2022 Penumbra, Inc. All rights reserved. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The canister is intended for single use only. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. INDIGO Aspiration System Intended Use Copyright 2022 Penumbra, Inc. All rights reserved. Worcester, Massachusetts Potential Adverse Events There was partial improvement of flow, but total occlusion remained. Return all damaged devices and packaging to the manufacturer/distributor. Giri J, Sista AK, Weinberg J, et al. Figure 1. This website is intended for US audience only. 0, 26. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. PDF May 15, 2018 - Food And Drug Administration Throughout each case, Lightning provides procedural feedback via audiovisual cues. Do not re-infuse blood or fluid from the canister back into the patient. The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. chronic clot, atherosclerotic plaque) Initial angiogram showing high thrombus burden in the left circumflex artery. Return all damaged devices and packaging to the manufacturer/distributor. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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 Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 1. Use prior to the Use By date. suhail.dohad@cshs.org 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. Ballad CVA Heart & Vascular Institute She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. LIGHTNING Aspiration Tubing Indication for Use System Chair, Clinical Research The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. The product-specific content of this website is intended for use by healthcare professionals only. The Swan-Ganz catheter was exchanged over a long V18 wire. Saint Louis, Missouri 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). . The means of mains disconnect is to remove the power cord. Do not use open or damaged packages. Use only waterbased solvents for cleaning. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The complaint has been evaluated. 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. 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. US physicians publish "first reported use" of Indigo aspiration system Possible complications include, but are not limited to, the following: acute vessel occlusion; air embolism; allergic reaction and anaphylaxis from contrast media or device material; anemia; arrhythmia; arteriovenous fistula; cardiac injury, cardiac perforation, cardiac tamponade; cardio-respiratory arrest; compartment syndrome; death; emboli; emergent surgery; foreign body embolization; hematoma or hemorrhage at access site; hemoptysis; hemorrhage; hypotension/hypertension; infarction leading to organ damage; infection; ischemia; myocardial infarction; neurological deficits including stroke; pneumothorax; pseudoaneurysm; renal impairment or acute renal failure from contrast media; residual thrombus due to inability to completely remove thrombus or control blood flow; respiratory failure; valvular damage; vessel spasm, thrombosis, dissection (intimal disruption), or perforation. 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 introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. Return all damaged devices and packaging to the manufacturer/distributor. 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. skin is red but turns white when pressed Prior to use, please consult device labeling and instructions for use. Potential Adverse 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. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 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. The cerebral vasculature For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Indigo System CAT RX | Penumbra Inc Possible complications include, but are not limited to, the following: No modification of this equipment is allowed. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels.
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