cat8 penumbra catheter

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 . With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Use prior to the Use By date. Penumbra Augments Vascular Franchise with Latest Indigo System Launch Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. 0, and 37. Contraindications Not for use in the coronaries or the neurovasculature. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. Do not block bottom air vents. 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. 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. 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. 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. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Maintain a constant infusion of appropriate flush solution. The means of mains disconnect is to remove the power cord. System Chair, Clinical Research 2. Penumbras IndigoAspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. Figure 2. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Do not use kinked or damaged devices. To prevent fire or shock hazard, use a replacement power cord of equal rating. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Contraindications There are no contraindications. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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. 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. Lightning comes packaged with the Indigo CAT7 or CAT12. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. Initial angiogram showing high thrombus burden in the RCA. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. Medical Director, Aortic Disease and Ischemic Limb Disease MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. After one pass with CAT RX, the initial occlusion was removed. CAT8XTORQ115KIT-NS. 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. 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. 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. If the cause cannot be determined, withdraw the device or system as a unit. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. LIGHTNING Aspiration Tubing is a sterile aspiration tubing component of the INDIGO Aspiration System and is intended to serve as a conduit to assist in thrombus removal and restoration of blood flow in the peripheral vasculature and for the treatment of pulmonary embolism. Figure 1. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . 8: Add BMK6F95M-NE . MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. The CAT family of catheters is 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. Circulation. Learn more about Lightning. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. Indigo System - Vascupedia Copyright 2022 Penumbra, Inc. All rights reserved. Indigo Aspiration System Intended Use function gtag(){dataLayer.push(arguments);} 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 built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Penumbra enrols first patient in CHEETAH Study of Indigo CAT RX device Penumbra ENGINE Indication For Use 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. 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 . To prevent fire or shock hazard, use a replacement power cord of equal rating. Cedars Sinai Medical Center The patient received a 3.5- X 38-mm everolimus-eluting stent (Synergy drug-eluting stent [DES], Boston Scientific Corporation) with postdilation optimized by intravascular ultrasound (IVUS) and was then sent to the step-down unit. Missouri Baptist Medical Center 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 INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Potential Adverse Events 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. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. Warnings Applicant. 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). Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The product-specific content of this website is intended for use by healthcare professionals only. 22. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . Bradenton Cardiology Center/Manatee Memorial Hospital Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. 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 resterilize or reuse. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. The pain became more intense and constant, so he presented to the ED. Do not resterilize or reuse. 0, 24. 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.

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