The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Penumbra, Inc. One Penumbra Place. Cedars Sinai Medical Center Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). 2: Add Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. The patient remained on cangrelor with no need for tirofiban. Contraindications Catheters & Separators. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. 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. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. 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 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. 0 cm from the distal tip. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Initial angiogram showing high thrombus burden in the left circumflex artery. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 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. This content is not intended to offer professional medical advice. function gtag(){dataLayer.push(arguments);} Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. 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. Potential Adverse Events Circulation. This website is intended for US audience only. University of Massachusetts Medical School Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. 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). Figure 3. Otherwise, this could result in degradation of the performance of this equipment. The procedure was completed with the same catheter. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. The Penumbra P logos, 3D, 3D Revascularization Device, ACE, BENCHMARK, CAT, Indigo, LANTERN, MAX, Neuron, Neuron MAX, Penumbra ENGINE, Penumbra JET, Penumbra System, Penumbra SMART COIL, POD, Ruby, Separator, Velocity, and WAVE are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. The pulmonary capillary wedge pressure is 10 mmHg. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Figure 1. window.dataLayer = window.dataLayer || []; Separator 8, 150 cm Length, 0.072 in. . Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. An Interview With Binita Shah, MD, MS, FACC, FSCAI, By Mansi Oberoi, MD; M. Chadi Alraies, MD; and Poonam Velagapudi, MD, MS, Left Main Disease and Bifurcation Revascularization in Female Patients, By Tara L. Jones, MD, PharmD, and Valeria Paradies, MD, By Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, Applying Team-Based Care Delivery to Interventional Cardiology: Learnings from the 2022 MedAxiom CV APP Survey, Understanding Sex Differences in Acute and Chronic Coronary Syndromes, By F. Aaysha Cader, MBBS, MD, MRCP(UK), MSc(Oxon); Rudaynah Amein Alali, MBBS, Internal Medicine Board, Interventional Cardiology Fellowship, RCPI; and Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, SuperSaturated Oxygen Therapy: Cases and Cocktails Event Winning Presentations, With Charishma Nallapati, MD; Amer N. Kadri, MD; James Richard Spears, MD; Zaid Al-Jebaje, MD; Babar Basir, DO; and Khaldoon Alaswad, MD, FACC, FSCAI. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The deliverability and continuous aspiration power were essential to achieving restoration of flow supporting a positive patient outcome to help heal this case of CLI. Final angiogram after stent placement showing resolution of underlying disease. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. 2023 Bryn Mawr Communications II, LLC. 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 combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 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. Created with Sketch. Use prior to the Use By date. 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. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. Precautions Copyright 2023 Penumbra, Inc. All rights reserved. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. UMassMemorial University Campus Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. 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. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. This website is intended for US audience only. Mathews SJ, Brown C, Kolski B, et al. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. Possible complications include, but are not limited to, the following: Distal posterior tibial artery emboli occlusion. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. The product-specific content of this website is intended for use by healthcare professionals only. The low-profile catheter and Penumbra ENGINE are easy to set up and use. 3. The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. waqas.qureshi@umassmemorial.org Do not use in an oxygen rich environment. Precautions The device is intended for single use only. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. Throughout each case, Lightning provides procedural feedback via audio visual cues. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Do not reuse. Jolly SS, Cairns JA, Yusuf S, et al. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. 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. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Sista A. Indigo aspiration system for acute pulmonary embolism. Indigo System CAT RX tracking through the distal posterior tibial artery. Applicant. Device Name. 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. In our practice, we have been able to more accurately define percutaneous transluminal coronary angioplasty and stent length as a result of this increased visualization. INDIGO System LIGHTNING Aspiration Tubing Intended Use 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 . Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. 0 cm from the hub. 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. Do not resterilize or reuse. UPC: Current Stock: This item is out of stock. IN-DATE. 0, 24. If the cause cannot be determined, withdraw the device or system as a unit. Maintain a constant infusion of appropriate flush solution. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. This website is intended for US audience only. Return all damaged devices and packaging to the manufacturer/distributor. 2019;140:e774-e801. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). right-arrow 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. Otherwise, this could result in degradation of the performance of this equipment. Units in stock: 1. Final angiogram showing resolution of extensive thrombus burden. 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). A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). 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 PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 System Chair, Clinical Research Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. 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. 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. PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8 DXE: Back to Search Results: Model Number CAT8XTORQ115KIT-S: Device Problems Break (1069); Physical Resistance/Sticking (4012) Patient Problem No Clinical Signs, Symptoms or Conditions (4582) Event Date 05/19/2021: Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. Contraindications 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. Penumbra Aspiration Pump: The complaint has been evaluated. function gtag(){dataLayer.push(arguments);} o The Penumbra Indigo System Separator is intended for use with our Indigo System's family of catheters to enable the removal of a wide range of thrombus. Potential Adverse Events Enter your email address and we will contact you. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. N Engl J Med. No modification of this equipment is allowed. 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. 2. LIGHTNING Aspiration Tubing Indication for Use 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 Aspiration System 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Use only waterbased solvents for cleaning. 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.
American Airlines Flight 191 Passenger List,
Topher Grace Venom Return,
Gaited Morgan Stallions At Stud,
Deliveroo Refusing Refund,
Articles C
