Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. The procedure was completed with the same catheter. Indication For Use window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} Disclosures: Consultant to Penumbra, Inc. An 83-year-old woman transferred from an outside hospital presented with acute shortness of breath, was hypotensive, and was intubated. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Precautions 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. 5 and 94. With a maximised inner diameter of 0.08 (2.1 mm) and a 7 French (2.3 mm) outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. Use prior to the Use By date. If the cause cannot be determined, withdraw the device or system as a unit. Potential Adverse Events The complaint has been evaluated. The means of mains disconnect is to remove the power cord. 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. This website is intended for US audience only. 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. 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. function gtag(){dataLayer.push(arguments);} 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. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. Initial angiogram showing high thrombus burden in the left circumflex artery. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. Pinterest; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm Penumbra System) Model #: CAT8XTORQ115KIT OEM: Penumbra System Expiration Date: 2022 Size : 8Fr x 115cm . waqas.qureshi@umassmemorial.org With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. This content is not intended to offer professional medical advice. 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 block bottom air vents. 0, and 37. The CAT family of catheters is the foundation of Penumbra's Indigo System. 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. Brandenton, Florida Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 0, 23. 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. 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. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. When performing aspiration, ensure that the INDIGO Aspiration Tubing 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. 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. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. 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. No modification of this equipment is allowed. 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. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Final angiogram after stent placement showing resolution of underlying disease. The device is intended for single use only. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. Penumbra ENGINE Intended Use Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. Otherwise, this could result in degradation of the performance of this equipment. Separator 8, 150 cm Length, 0.072 in. This website is intended for US audience only. Indigo System CAT RX tracking through the distal posterior tibial artery. Figure 3. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . 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 CAT family of catheters is the foundation of Penumbra's Indigo system. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. INDIGO Aspiration Tubing: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. This press release features multimedia. Randomized trial of primary PCI with or without routine manual thrombectomy. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Giri J, Sista AK, Weinberg J, et al. 1.10 Summary of Non-Clinical Data As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Disclosures: Consultant to Penumbra, Inc. A 59-year-old man with a history of hypertension and tobacco use presented with an inferior-posterior acute myocardial infarction (MI). Saxon RR, Benenati JF, Teigen C, et al. The product-specific content of this website is intended for use by healthcare professionals only. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 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. 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. 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 . For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 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. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. She was in a rehab facility prior to this new event recovering from her CVA. 2. The INDIGO SEPARATOR is not intended for use as a guidewire. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Return all damaged devices and packaging to the manufacturer/ distributor. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. CAT7 and CAT12 are the next generation of the Indigo System Catheters. gtag('js', new Date()); The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Use only waterbased solvents for cleaning. To prevent fire or shock hazard, use a replacement power cord of equal rating. 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. QUICK VIEW. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 2. 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. Penumbras IndigoAspiration 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 a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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. INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. 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. Return all damaged devices and packaging to the manufacturer/distributor. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. 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. System Chair, Clinical Research Do not resterilize or reuse. 0, 26. If the cause cannot be determined, withdraw the device or system as a unit. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. 3. Jawairia Sahar K. Mirza, MBBS If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. In 2014, Penumbra broke into the peripheral thrombectomy space with the release of the first Indigo System catheters, the 5-F CAT5 catheter and the 3-F CAT3 catheter (Penumbra, Inc.). Copyright 2022 Penumbra, Inc. All rights reserved. Indication For Use Potential Adverse Events 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. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Figure 1. Disclosures: None. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . Jolly SS, Cairns JA, Lavi S, et al. SVG occlusions can be challenging to resolve using traditional treatment modalities. Final angiogram showing resolution of extensive thrombus burden. 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. The canister is intended for single use only. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . This is potentially more effective than diminished syringe-based aspiration. Return all damaged devices and packaging to the manufacturer/distributor. S. Jay Mathews, MD, MS, FACC Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Created with Sketch. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. PENUMBRA ENGINE Indication for Use Cedars Sinai Medical Center Because the patient was not a candidate for thrombolysis, the decision was made to intervene with the Indigo System CAT8XTORQ115 and SEP 8, which were advanced sequentially into the right then left pulmonary artery. Otherwise, this could result in degradation of the performance of this equipment. 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. TIMI 3 flow was achieved in 88% of cases. 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. Potential Adverse Events 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. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. Suhail Dohad, MD, FACC 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. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. 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 initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. INDIGO Aspiration Catheters and Separators: If repositioning of the INDIGO Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard catheter and guidewire techniques. These pages are not intended for patients or for members of the general public. 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 Indigo CAT RX Aspiration Catheters and Indigo Separator 4: Mechanical Thrombectomy. The large aspiration lumen and highly trackable, low-profile design coupled with the power of the Penumbra ENGINE resulted in the successful removal of the emboli in one pass. function gtag(){dataLayer.push(arguments);} Alameda, CA 94502. Final angiogram with complete TIMI 3 flow after the use of CAT RX. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use The pulmonary capillary wedge pressure is 10 mmHg. 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. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Maintain a constant infusion of appropriate flush solution. 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; Use prior to the Use By date. Learn more about Lightning. Otherwise, this could result in degradation of the performance of this equipment. 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.