Do not use in oxygen rich environment. 5, 19. 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. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The CAT family of catheters is the foundation of Penumbras Indigo System. Prior to use, please consult device labeling and instructions for use. 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. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 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; Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. BJC Cardiology Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 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. Use prior to the Use By date. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. The low-profile catheter and Penumbra . Potential Adverse Events Final angiogram after stent placement showing resolution of underlying disease. These types of burns heal withing 5 or 6 days without permanent scarring. waqas.qureshi@umassmemorial.org 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. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. INDIGO Aspiration Tubing: 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. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. K180412. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. 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. Units in stock: 1. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. No conversations found. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. Brandenton, Florida Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . 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. CAT7 and CAT12 are the next generation of the Indigo System Catheters. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. There were no cases of 30-day cardiovascular death or post procedural stroke. Latest System Designed for Single Session Arterial Thrombus Removal News 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. 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. After IVUS, the stent was dilated to 3.75 mm. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. INDIGO Aspiration Tubing: CAT7 and CAT12 are the next generation of the Indigo System catheters. 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. 2. CAT RX is an essential tool in our percutaneous coronary armamentarium. The complaint has been evaluated. No modification of this equipment is allowed. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The cerebral vasculature 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. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. SVG occlusions can be challenging to resolve using traditional treatment modalities. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. 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. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon Do not use kinked or damaged devices. Jolly SS, Cairns JA, Yusuf S, et al. Engineered with neuro-tracking technology, CAT RX is designed to navigate tortuous anatomy and track to distal coronary vasculature while maintaining sustained mechanical aspiration with the Penumbra ENGINE. 0, and 37. Otherwise, this could result in degradation of the performance of this equipment. Do not resterilize or reuse. Lightning 7 expands Penumbra's offering of the Indigo Aspiration System with Intelligent Aspiration for mechanical thrombectomy and is designed for single session arterial thrombus removal. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. Figure 2. Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. Do not use in oxygen rich environment. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . 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. 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. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. Figure 2. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 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. 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. In patients with submassive pulmonary embolism with compromised right ventricular function and elevated biomarkers, the Indigo System is an excellent frontline tool offering a safe and effective1 treatment option. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. 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. Return all damaged devices and packaging to the manufacturer/ distributor. Worcester, Massachusetts Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. kolskiwellness@gmail.com 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. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Penumbra, Inc. One Penumbra Place. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D 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. 8: Add BMK6F95M-NE . Throughout each case, Lightning provides procedural feedback via audiovisual cues. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. 2015;372:1389-1398. Initial angiogram showing high thrombus burden in the left circumflex artery. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Do not re-infuse blood or fluid from the canister back into the patient. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. 2. 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 . Pela bainha, foi introduzido o dispositivo de aspirao Penumbra Indigo System CAT8 XTORQ (Penumbra Inc., Alameda, Califrnia, Estados Unidos) em trombo segmentar, lobar ou arterial pulmonar principal, sendo realizada aspirao contnua (Figuras 2 e 3). Figure 1. Penumbra's not relying on software alone. This content is not intended to offer professional medical advice. 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. The means of mains disconnect is to remove the power cord. Copyright 2022 Penumbra, Inc. All rights reserved. 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. 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. Indigo System CAT RX tracking through the distal posterior tibial artery. Contraindications There are no known contraindications. 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. Penumbra Aspiration Pump: 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). Warnings Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Indigo System Intended Use The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. 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. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. The means of mains disconnect is to remove the power cord. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Do not use kinked or damaged devices. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. System Chair, Clinical Research Disclosures: None. Precautions 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. Potential Adverse Events Copyright 2023 Penumbra, Inc. All rights reserved. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. N Engl J Med. Alameda, CA 94502. Equipment is not safe for MR use. 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. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. Copyright 2022 Penumbra, Inc. All rights reserved. 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. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Disclosures: None. 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 CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. The device is intended for single use only. 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. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Mechanical Thrombectomy. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. The CAT family of catheters is the foundation of Penumbra's Indigo System. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 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 . Final angiogram after mechanical thrombectomy with CAT8 and SEP8. Do not use in an oxygen rich environment. INDIGO Aspiration Catheters and Separators: Separator 8, 150 cm Length, 0.072 in. The product-specific content of this website is intended for use by healthcare professionals only. Tareq Kass-Hout. 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. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. 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. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Potential Adverse Events Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Do not resterilize or reuse. Return all damaged devices and packaging to the manufacturer/distributor. 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. N Engl J Med. 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. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Use prior to the Use By date. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 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.
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