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. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Do not use open or damaged packages. 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. 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. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon suhail.dohad@cshs.org gtag('js', new Date()); Initial angiogram showing high thrombus burden in the RCA. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). 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 prior to the Use By date. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. To prevent fire or shock hazard, use a replacement power cord of equal rating. Otherwise, this could result in degradation of the performance of this equipment. Return all damaged devices and packaging to the manufacturer/distributor. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. function gtag(){dataLayer.push(arguments);} The Indigo Aspiration System is contraindicated in: This website is intended for US audience only. Equipment is not safe for MR use. K180412. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Do not use in an oxygen rich environment. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. CAT8XTORQ115KIT-NS. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). 2019;140:e774-e801. Final angiographic result of SVG. Throughout each case, Lightning provides procedural feedback via audiovisual cues. 2. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Ballad CVA Heart & Vascular Institute The system uses Penumbra's RED reperfusion catheters. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Indication For Use Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. 5, 19. Precautions Aspiration Tubing Intended Use 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. INDIGO Aspiration Tubing: 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. 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. N Engl J Med. 2015;372:1389-1398. Final angiogram after stent placement showing resolution of underlying disease. Do not use in oxygen rich environment. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. 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. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Return all damaged devices and packaging to the manufacturer/distributor. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. 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). Figure 2. Contraindications Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. INDIGO SEPARATOR 4 is intended to be used with INDIGO CAT RX Aspiration Catheter to clear the distal end of the catheter lumen should it be blocked with thrombus. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Director of Cardiac & Peripheral Cath Lab Jolly SS, Cairns JA, Yusuf S, et al. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. 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. 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. CAT RX is an essential tool in our percutaneous coronary armamentarium. 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. The complaint indicated that the cat8 was kinked during the procedure. Do not resterilize or reuse. Smidt Heart institute 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 . Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. 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. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. Otherwise, this could result in degradation of the performance of this equipment. 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 . Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Further evaluation of the returned device revealed kinks in the catheter shaft. 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. Contraindications There are no known contraindications. Mathews SJ, Brown C, Kolski B, et al. The cat8 was kinked approximately 69. Bradenton Cardiology Center/Manatee Memorial Hospital Indigo Separator 4 is intended to be used with Indigo CAT RX Aspiration Catheter to clear the distal end of the catheter lumen should it be blocked with thrombus. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. Indigo System | Computer-Aided Mechanical Aspiration. 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. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. INDIGO System LIGHTNING Aspiration Tubing Intended Use BJC Cardiology Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Device Name. Contraindications There are no contraindications. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Do not resterilize or reuse. Maintain a constant infusion of appropriate flush solution. 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. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Possible complications include, but are not limited to, the following: The Indigo Aspiration System is comprised of several devices: The Indigo System is used as a first-line approach or rescue therapy for arterial and venous thrombotic events. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. This content is not intended to offer professional medical advice. 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. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. 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 the PENUMBRA ENGINE. 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. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. Return all damaged devices and packaging to the manufacturer/distributor. 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. Possible complications include, but are not limited to, the following: 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. Figure 1. Distal posterior tibial artery emboli occlusion. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . This website is intended for US audience only. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Available in a selection of sizes, the CAT family can provide access to distal peripheral . 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. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Figure 3. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. Copyright 2023 Penumbra, Inc. All rights reserved. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . No modification of this equipment is allowed. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. A Penumbra CAT8 catheter was placed into the right upper lobe, right middle lobe, and right lower lobe, and aspiration with a separator was performed. function gtag(){dataLayer.push(arguments);} University of Massachusetts Medical School Precautions The product-specific content of this website is intended for use by healthcare professionals only. The low-profile catheter and Penumbra . Use only water-based solvents for cleaning. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Potential Adverse Events She was in a rehab facility prior to this new event recovering from her CVA. The Indigo System Catheter CAT8 was used across 22 sites in the United States in patients with submassive PE who did not receive thrombolytics (98.3%), with a . 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. 0, 23. Warnings Use prior to the Use By date. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. 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. 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. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. Do not use kinked or damaged devices. Created with Sketch. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. 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. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 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. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. Jolly SS, Cairns JA, Lavi S, et al. 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. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. Warnings Mechanical thrombectomy was performed. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. N Engl J Med. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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. Copyright 2022 Penumbra, Inc. All rights reserved. Indication For Use Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Do not re-infuse blood or fluid from the canister back into the patient. Do not use open or damaged packages. Final angiogram with complete TIMI 3 flow after the use of CAT RX. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). 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 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). UPC: Current Stock: This item is out of stock. Saxon RR, Benenati JF, Teigen C, et al. 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. These pages are not intended for patients or for members of the general public. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. Latest System Designed for Single Session Arterial Thrombus Removal News 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. 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.
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