Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. Maintain a constant infusion of appropriate flush solution. 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. 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. Device Name. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump.
Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). 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. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Do not re-infuse blood or fluid from the canister back into the patient. No conversations found.
Mechanical Thrombectomy | Medical Billing and Coding Forum - AAPC Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . The Indigo Aspiration System is contraindicated in:
MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION 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. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. Copyright 2022 Penumbra, Inc. All rights reserved. gtag('js', new Date()); This content is not intended to offer professional medical advice. Figure 1. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: 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. Manual aspiration suffers from diminished aspiration force as fluid fills in the syringe, potentially resulting in systemic embolization during catheter removal, as shown in the TOTAL trial published in 2015 (Figure 1).1 Subgroup analysis of patients with high thrombus burden was explored that highlighted the potential for improved outcomes. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Cedars Sinai Medical Center
Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Vedantham S, Goldhaber SZ, Julian JA, et al.
Penumbra, CAT8XTORQ115, Penumbra CAT8 Indigo Aspiration Catheter, XTorq Penumbra ENGINE Intended Use Circulation. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Do not resterilize or reuse. This content is not intended to offer professional medical advice. Contraindications 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; Jolly SS, Cairns JA, Lavi S, et al. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Penumbra Aspiration Pump: Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. Penumbra, Inc. One Penumbra Place. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. Precautions The device is intended for single use only. The pulmonary capillary wedge pressure is 10 mmHg. 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 initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. Potential Adverse Events Warnings/Precautions 8: Add BMK6F95M-NE . waqas.qureshi@umassmemorial.org
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. CAT RX has allowed us to rethink how we approach these occluded SVGs.
MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 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. 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. Figure 2. This is potentially more effective than diminished syringe-based aspiration. 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. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. 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 This content is not intended to offer professional medical advice. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673
PENUMBRA: CAT6 - WestCMR Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. Throughout each case, Lightning provides procedural feedback via audiovisual cues. The CAT family of catheters is the foundation of Penumbras Indigo System. Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious .
Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm Equipment is not safe for MR use. 2019;140:e774-e801. Conclusions: evaluation of the cat8 revealed that the device was fractured.
Penumbra enrols first patient in CHEETAH Study of Indigo CAT RX device Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Do not use open or damaged packages. Figure 1. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. Use prior to the Use By date. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice.
Penumbra Announces U.S. Commercial Availability of INDIGO System Copyright 2022 Penumbra, Inc. All rights reserved. Do not use open or damaged packages. 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). Missouri Baptist Medical Center
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 pain became more intense and constant, so he presented to the ED. 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. The patient underwent six shocks and was intubated while CAT RX was delivered through the freshly placed 3.5- X 38-mm DES to the PDA. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon
Indigo System Catheters & Separators | Penumbra Inc Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Director of Cardiac Catheterization Lab, PERT & Structural Heart
Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 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 Announces U.S. Commercial Availability of INDIGO System Worcester, Massachusetts
Only use replacement fuse with correct rating (see Table 1 for fuse rating). The device is intended for single use only. 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. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Tareq Kass-Hout. 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. 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. Catheters & Separators. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Do not resterilize or reuse. Return all damaged devices and packaging to the manufacturer/distributor. 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. This website is intended for US audience only. Initial angiogram of the right pulmonary artery showing pulmonary embolism. Use prior to the Use By date. 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. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . CAT RX is an essential tool in our percutaneous coronary armamentarium. 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 . The patient remained on cangrelor with no need for tirofiban. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. There was partial improvement of flow, but total occlusion remained. The Indigo Aspiration System is comprised of several devices: The Indigo System may be used as a first-line approach or rescue therapy for arterial and venous thrombotic events. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. The product-specific content of this website is intended for use by healthcare professionals only. 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 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. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. window.dataLayer = window.dataLayer || []; Do not use in an oxygen rich environment. Throughout each case, Lightning provides procedural feedback via audio visual cues. Do not re-infuse blood or fluid from the canister back into the patient. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). Results of EXTRACT-PE Trial presented at Vascular InterVentional Advances (VIVA) Annual Meeting Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced that the EXTRACT-PE trial successfully met the primary endpoints, demonstrating the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with . 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.
How Penumbra's smart-sucking algorithms and catheters speed up clot