Indigo System Intended Use Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. The Indigo Aspiration System is contraindicated in: Contraindications Not for use in the coronaries or the neurovasculature. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. 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. function gtag(){dataLayer.push(arguments);} Potential Adverse Events If repositioning of the INDIGO Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard catheter and guidewire techniques. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Mechanical thrombectomy was performed. 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 System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . 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 . 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. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. 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. Mechanical Thrombectomy. The means of mains disconnect is to remove the power cord. 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. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 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. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. 3. Final angiogram after stent placement showing resolution of underlying disease. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. The device is intended for single use only. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. 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. 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). Initial angiogram showing high thrombus burden in the RCA. This is potentially more effective than diminished syringe-based aspiration. Contraindications SVG occlusions can be challenging to resolve using traditional treatment modalities. This website is intended for US audience only. Created with Sketch. Precautions The device is intended or single use only. Not for use in the coronaries or the neurovasculature. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. Device Name. 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. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. 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. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Warnings 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. Penumbras Indigo Aspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism and/or certain central circulatory system conditions such as pulmonary emboli. The patient remained on cangrelor with no need for tirofiban. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). 1. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Launches Indigo System Lightning 12 in U.S. Appoints Corey L. Teigen, M.D., as Chief Scientific Officer and James F. Benenati, M.D., FSIR, as Chief Medical Officer Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced its next phase for vascular franchise growth with U.S. commercial availability of the Indigo System Lightning 12 and . Aspiration or disruption of thrombus with traditional diminished syringe-based aspiration or other mechanical devices is difficult, often incomplete, and has been associated with high complication rates.1 Use of medical therapy, such as powerful anticoagulants and thrombolytics (ie, tissue plasminogen activator), may carry a high risk of bleeding.2 The Indigo System was designed to provide sustained aspiration with Penumbra ENGINE to effectively remove thrombus, while reducing the risk of bleeding complications.3 The Indigo System utilizes atraumatic catheters varying in diameters from 3.4 to 8 F and lengths ranging from 50 to 150 cm. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. The device is intended for single use only. 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. Do not use kinked or damaged devices. These pages are not intended for patients or for members of the general public. Do not use kinked or damaged devices. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Distal OD. If the cause cannot be determined, withdraw the device or system as a unit. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Interventional Cardiology Director of Cardiac & Peripheral Cath Lab 5, 19. IN-DATE. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 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. 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. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. Vedantham S, Goldhaber SZ, Julian JA, et al. Use prior to the Use By date. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. The INDIGO SEPARATOR is not intended for use as a guidewire. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. 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. Randomized trial of primary PCI with or without routine manual thrombectomy. Related Items. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Do not re-infuse blood or fluid from the canister back into the patient. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. Tareq Kass-Hout. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. System Chair, Clinical Research The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. Figure 1. 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. If the cause cannot be determined, withdraw the device or system as a unit. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. J Vasc Interv Radiol. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. 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. 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. Indigo System | Computer-Aided Mechanical Aspiration. 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). The removal of fibrous, adherent or calcified material (e.g. S. Jay Mathews, MD, MS, FACC Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Copyright 2022 Penumbra, Inc. All rights reserved. Penumbra ENGINE Indication For Use Director of Cardiac Catheterization Lab, PERT & Structural Heart The cerebral vasculature 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. These pages are not intended for patients or for members of the general public. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Otherwise, this could result in degradation of the performance of this equipment. If the cause cannot be determined, withdraw the device or system as a unit. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. 0, and 37. Do not use in oxygen rich environment. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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. Sista A. Indigo aspiration system for acute pulmonary embolism. 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. Penumbra's not relying on software alone. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . This press release features multimedia. 2023 Bryn Mawr Communications II, LLC. 1. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Vascular Thrombectomy. Available in a selection of sizes, the CAT family can provide access to distal peripheral . Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Penumbra ENGINE. Penumbra ENGINE Intended Use Precautions Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. The product-specific content of this website is intended for use by healthcare professionals only. Kingsport, Tennessee If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 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 CAT family of catheters is the foundation of Penumbra's Indigo System. The Indigo System aspiration catheters are available in a range of lengths and diameters that, when connected to the Penumbra ENGINE pump, can atraumatically remove the thrombus present in various peripheral vascular beds. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. 2: Add The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. Alameda, CA 94502. 2019;140:e774-e801. She was in a rehab facility prior to this new event recovering from her CVA. 5 and 94. These types of burns heal withing 5 or 6 days without permanent scarring. Aspiration Tubing Intended Use Saxon RR, Benenati JF, Teigen C, et al. 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. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions.
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