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Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Warnings/Precautions The canister is intended for single use only. N Engl J Med. Catheters & Separators. If the cause cannot be determined, withdraw the device or system as a unit. function gtag(){dataLayer.push(arguments);} Brandenton, Florida 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. Do not re-infuse blood or fluid from the canister back into the patient. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. Latest System Designed for Single Session Arterial Thrombus Removal News Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Warnings/Precautions A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). Missouri Baptist Medical Center window.dataLayer = window.dataLayer || []; Manual aspiration using a Pronto V3 (Teleflex) catheter restored some flow, however, distal embolization to the posterior descending artery (PDA) immediately caused right ventricular cardiac arrest (Figure 2). Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. left-arrow 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. 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. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Do not use kinked or damaged devices. Initial angiogram of the right pulmonary artery showing pulmonary embolism. 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 . 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. 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. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 N Engl J Med. Director of Cardiac Catheterization Lab, PERT & Structural Heart Next Article 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. . Order Qty. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Conclusions: evaluation of the cat8 revealed that the device was fractured. Penumbra Augments Vascular Franchise with Latest Indigo System Launch 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Launches Indigo System Lightning 12 in U.S. Appoints Corey L. Teigen, M.D., as Chief Scientific Officer and James F. Benenati, M.D., FSIR, as Chief Medical Officer Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced its next phase for vascular franchise growth with U.S. commercial availability of the Indigo System Lightning 12 and . 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. Her heart rate was 110 beats per minute, elevated troponin levels at 4.5 ng/mL, and elevated brain natriuretic peptide at 1,164 pg/mL. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. window.dataLayer = window.dataLayer || []; Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Contraindications Distal OD. 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. Precautions The device is intended for single use only. The catheters (CAT3, CAT RX*, CAT5, CAT6, CAT8, CATD) vary in diameters from 3.4 to 8 F and lengths of 50 to 150 cm to . 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. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Do not use open or damaged packages. The procedure time was short (median of 37 minutes)the shortest demonstrated so far in an investigational device exemption (IDE) trial on patients with pulmonary embolism. Rethinking Thrombus Removal With the Indigo System: Introducing 5, 21. Jawairia Sahar K. Mirza, MBBS gus.theodos@bjc.org; @gtheodosmd Figure 2. The device is intended for single use only. PENUMBRA: SEP8 - Westcmr.com The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. Do not use open or damaged packages. Director of Cardiac & Peripheral Cath Lab Mechanical Power Aspiration With the Indigo - Endovascular Today Do not reuse. 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 PDF May 15, 2018 - Food And Drug Administration The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. These types of burns heal withing 5 or 6 days without permanent scarring. 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 . Return all damaged devices and packaging to the manufacturer/distributor. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. These pages are not intended for patients or for members of the general public. If the cause cannot be determined, withdraw the device or system as a unit. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. INDIGO Aspiration System Intended Use This case illustrates the vast improvement in aspiration technology with an easy-to-deliver, trackable catheter that maintains sustained aspiration for the duration of the procedure. Vascular Thrombectomy. Only use replacement fuse with correct rating (see Table 1 for fuse rating). S. Jay Mathews, MD, MS, FACC Indigo System CAT RX tracking through the distal posterior tibial artery. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. System Chair, Clinical Research Prior to use, please consult device labeling and instructions for use. QUICK VIEW. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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 ENGINE Intended Use The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. She had acute tubular necrosis with minimal urine output at the time of transfer. PENUMBRA: CAT3 - westcmr.com Do not use in oxygen rich environment. Medical Director, Aortic Disease and Ischemic Limb Disease 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. skin is red but turns white when pressed When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. 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. PENUMBRA ENGINE Indication for Use Disclosures: None. Use only waterbased solvents for cleaning. US physicians publish "first reported use" of Indigo aspiration system J Vasc Interv Radiol. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. 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. Indigo System | Penumbra Inc CAT RX has allowed us to rethink how we approach these occluded SVGs. Indication For Use Mechanical thrombectomy was performed. Penumbra Indigo System | Vascular Thrombectomy The Penumbra ENGINE addresses the limitations of traditional treatment options by providing sustained mechanical power aspiration for the duration of the procedure to help maximize efficiency of thrombus removal. 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 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. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arrhythmia; arteriovenous fistula; cardiac injury; cardio-respiratory arrest; death; device malfunction; distal embolization; emboli; excessive blood loss; 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; hemoptysis; respiratory failure; thromboembolic events. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 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. Innovation in Coronary Mechanical Thrombectomy: Indigo System CAT RX Do not use in an oxygen rich environment. 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. 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). Interventional Cardiology Ballad CVA Heart & Vascular Institute Distal posterior tibial artery emboli occlusion. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. 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. Two passes of CAT RX with the Penumbra ENGINE resulted in TIMI 3 flow restoration and retrieval of the distal emboli from the PDA (Figure 3). 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. University of Massachusetts Medical School Contraindications There are no known contraindications. 0, and 37. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. 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. 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 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. Use prior to the Use By date. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . 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. Figure 3. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. 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. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Penumbra, Inc. One Penumbra Place. Do not use in oxygen rich environment. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Bradenton Cardiology Center/Manatee Memorial Hospital Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). Precautions 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. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Figure 3. It will reduce service life of the Penumbra ENGINE. The means of mains disconnect is to remove the power cord. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. Jolly SS, Cairns JA, Lavi S, et al. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Return all damaged devices and packaging to the manufacturer/distributor. The pain became more intense and constant, so he presented to the ED. This is potentially more effective than diminished syringe-based aspiration. Return all damaged devices and packaging to the manufacturer/distributor. Prior to use, please consult device labeling and instructions for use. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . 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. function gtag(){dataLayer.push(arguments);} Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . 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.