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. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. Potential Adverse Events 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. Indication For Use The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). function gtag(){dataLayer.push(arguments);} 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. 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 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. Penumbra aspiration assistance | Medical Billing and Coding Forum - AAPC The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. To prevent fire or shock hazard, use a replacement power cord of equal rating. St. Joseph Hospital
Prior to use, please consult device labeling and instructions for use. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Utility of a power aspiration-based extraction technique as an initial and secondary approach in the treatment of peripheral arterial thromboembolism: results of the multicenter PRISM Trial. 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. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Penumbra ENGINE Intended Use gtag('js', new Date()); sjaymathewsmd@gmail.com
Initial angiography revealed an occlusion of the distal RCA. CAT7 and CAT12 are the next generation of the Indigo System Catheters. Final angiogram showing resolution of extensive thrombus burden. . 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. 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. Use prior to the Use By date. 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. Figure 3. Penumbras IndigoAspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Conclusions: evaluation of the cat8 revealed that the device was fractured. 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). Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. Director of Cardiac & Peripheral Cath Lab
The healthcare firm said that the Indigo CAT RX Aspiration Catheters . $399.00 EACH. 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. The CAT familyof catheters is the foundation of Penumbras Indigo System. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. 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. 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 Aspiration Catheter because it may damage the device. CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. The INDIGO SEPARATOR is not intended for use as a guidewire. Do not use open or damaged packages. Penumbra ENGINE Indication For Use Kingsport, Tennessee
Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. 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. SciELO - Brasil - Suporte mecnico extracorpreo e trombectomia por If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Initial angiogram showing high thrombus burden in the RCA. 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 CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. PENUMBRA ENGINE Indication for Use These pages are not intended for patients or for members of the general public. Do not re-infuse blood or fluid from the canister back into the patient. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. 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. Indication For Use Warnings The means of mains disconnect is to remove the power cord. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. Figure 1. The canister is intended for single use only. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. Potential Adverse Events 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. window.dataLayer = window.dataLayer || []; The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. This content is not intended to offer professional medical advice. 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. Copyright 2023 Penumbra, Inc. All rights reserved. Prior to use, please consult device labeling and instructions for use. Created with Sketch. Because the patient was not a candidate for thrombolysis, the decision was made to intervene with the Indigo System CAT8XTORQ115 and SEP 8, which were advanced sequentially into the right then left pulmonary artery. (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. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . 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. If repositioning of the INDIGO CAT RX Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard guidewire techniques. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Precautions The device is intended for single use only. This website is intended for US audience only. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. The product-specific content of this website is intended for use by healthcare professionals only. If the cause cannot be determined, withdraw the device or system as a unit. Final angiogram with complete TIMI 3 flow after the use of CAT RX. 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. Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. The cerebral vasculature The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Due to our experience in such cases, sustained aspiration with the Indigo System CAT RX with Penumbra ENGINE has quickly become our frontline device, challenging the traditional method of manual aspiration in patients with thrombi and emboli in the coronary arteries. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Only use replacement fuse with correct rating (see Table 1 for fuse rating). A, Penumbra Indigo System Continuous Aspiration - ResearchGate If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. The CAT family of catheters is the foundation of Penumbra's Indigo system. 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. There were no cases of 30-day cardiovascular death or post procedural stroke. To prevent fire or shock hazard, use a replacement power cord of equal rating. System Chair, Clinical Research
Penumbra Cat 8 - IndiaMART 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 safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Copyright 2022 Penumbra, Inc. All rights reserved. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. Gus Theodos, MD, FACC, FSCAI
The device is intended for single use only. This content is not intended to offer professional medical advice. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . This website is intended for US audience only. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. gtag('js', new Date()); The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Rethinking Thrombus Removal With the Indigo System: Introducing 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. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Possible complications include, but are not limited to, the following: Contraindications The penumbra cat8 indigo system (cat8) was kinked approximately 4. 3. Contraindications The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. INDIGO Aspiration System Indication for Use INDIGO System LIGHTNING Aspiration Tubing Intended Use Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. These pages are not intended for patients or for members of the general public. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. UPC: Current Stock: . Device Name. 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The procedure was completed with the same catheter. Penumbra Indigo Aspiration System IDE Trial for Acute Pulmonary Penumbra Announces U.S. Commercial Availability of INDIGO System Circulation. With the maximized inner diameter of 0.082 and a 7 French outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . 0, 26. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. . 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. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. 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. Potential Adverse Events Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arrhythmia/fibrillation; arteriovenous fistula; death; device malfunction; distal embolization; emergent surgery; false aneurysm formation; hematoma, hemorrhage, or blood loss at access site; hematoma, hemorrhage, or blood loss; hypotension; inability to completely remove thrombus or control blood flow; infection; ischemia; kidney damage from contrast media; myocardial infarction; neurological deficits including stroke; respiratory failure; thromboembolic events; vascular complications (including vessel spasm, thrombosis, intimal disruption, dissection, or perforation). Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Giri J, Sista AK, Weinberg J, et al. J Am Coll Cardiol. 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. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. 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 . 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. Worcester, Massachusetts
Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. If the cause cannot be determined, withdraw the device or system as a unit. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. 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). Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. Penumbra enrols first patient in CHEETAH Study of Indigo CAT RX device A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Otherwise, this could result in degradation of the performance of this equipment. Penumbra's Newest Generation of Indigo Aspiration System Receives FDA Categories. 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 Intended Use Penumbra, CAT8XTORQ115, Penumbra CAT8 Indigo Aspiration Catheter, XTorq Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Only use replacement fuse with correct rating (see Table 1 for fuse rating). 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 patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). 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 patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. The Penumbra CAT RX catheter was used in a total of 34 patients, with 71% STEMI, 23% NSTEMI, 3% UA, and 3% new onset heart failure. 0 cm from the distal tip. INDIGO Aspiration Catheters and Separators: Figure 1. waqas.qureshi@umassmemorial.org
When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Lightning Flash: The Most Powerful and Advanced Mechanical Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. gus.theodos@bjc.org; @gtheodosmd
This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. University of Massachusetts Medical School
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. The INDIGO Aspiration Tubing: 5 and 94. Vascular Thrombectomy. Warnings Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. INDIGO Aspiration Tubing: Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Director, Structural Heart
Copyright 2023 Penumbra, Inc. All rights reserved. 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 Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy.