Further evaluation of the returned device revealed kinks in the catheter shaft. QUICK VIEW. Figure 2. Brian Kolski, MD Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. N Engl J Med. There was partial improvement of flow, but total occlusion remained. Penumbra, a US-based provider of advanced therapies, has enrolled the first patient into the CHEETAH clinical study, designed to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. 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. Copyright 2023 Penumbra, Inc. All rights reserved. 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; function gtag(){dataLayer.push(arguments);} Distal posterior tibial artery emboli occlusion. 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. Contraindications There are no contraindications. Figure 2. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Use only water-based solvents for cleaning. 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. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . Throughout each case, Lightning provides procedural feedback via audio visual cues. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. 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. After one pass with mechanical thrombectomy using CAT RX, the thrombus was removed and flow was restored to the pedal arch via the plantar posterior tibial artery (Figure 2 and Figure 3). 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. 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. Director of Cardiac Catheterization Lab, PERT & Structural Heart 2. Figure 1. Penumbra's not relying on software alone. Contraindications Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Do not use in oxygen rich environment. Only use replacement fuse with correct rating (see Table 1 for fuse rating). She had acute tubular necrosis with minimal urine output at the time of transfer. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. 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. 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. In patients with submassive pulmonary embolism with compromised right ventricular function and elevated biomarkers, the Indigo System is an excellent frontline tool offering a safe and effective1 treatment option. 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. Initial angiography revealed an occlusion of the distal RCA. 2: Add Copyright 2022 Penumbra, Inc. All rights reserved. N Engl J Med. 2. 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. This is potentially more effective than diminished syringe-based aspiration. Return all damaged devices and packaging to the manufacturer/distributor. gus.theodos@bjc.org; @gtheodosmd It will reduce the service life of the PENUMBRA ENGINE. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. This website is intended for US audience only. Prior to use, please consult device labeling and instructions for use. K180412. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). 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. 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. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. The cerebral vasculature CAT7 and CAT12 are the next generation of the Indigo System Catheters. 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. 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. 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. Equipment is not safe for MR use. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. This press release features multimedia. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Potential Adverse Events The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. Warnings/Precautions 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. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. 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. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . Additional Details. The pulmonary capillary wedge pressure is 10 mmHg. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. The complaint indicated that the cat8 was kinked during the procedure. Figure 1. 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. Do not re-infuse blood or fluid from the canister back into the patient. Possible complications include, but are not limited to, the following: acute vessel occlusion; air embolism; allergic reaction and anaphylaxis from contrast media or device material; anemia; arrhythmia; arteriovenous fistula; cardiac injury, cardiac perforation, cardiac tamponade; cardio-respiratory arrest; compartment syndrome; death; emboli; emergent surgery; foreign body embolization; hematoma or hemorrhage at access site; hemoptysis; hemorrhage; hypotension/hypertension; infarction leading to organ damage; infection; ischemia; myocardial infarction; neurological deficits including stroke; pneumothorax; pseudoaneurysm; renal impairment or acute renal failure from contrast media; residual thrombus due to inability to completely remove thrombus or control blood flow; respiratory failure; valvular damage; vessel spasm, thrombosis, dissection (intimal disruption), or perforation. If the cause cannot be determined, withdraw the device or system as a unit. 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. To prevent fire or shock hazard, use a replacement power cord of equal rating. Initial angiogram showing high thrombus burden in the RCA. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The newly available Indigo CAT12 Aspiration Catheter (Penumbra, Inc.) was utilized to perform mechanical thrombectomy of the FV, CFV, and EIV and CIV without the use of thrombolytics . 2015;372:1389-1398. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Otherwise, this could result in degradation of the performance of this equipment. Do not use open or damaged packages. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. 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. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Units in stock: 1. After one pass with CAT RX, the initial occlusion was removed. 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 Penumbra Aspiration Pump: 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. 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. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Maintain a constant infusion of appropriate flush solution. indicated to connect the INDIGO CAT RX 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. Disclosures: Consultant to Penumbra, Inc. A 92-year-old man with a history of coronary artery disease (treated previously with coronary artery bypass graft) and severe aortic stenosis (treated previously with transcatheter aortic valve replacement) presented to the ED with chest pain. 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 . Initial angiogram of the right pulmonary artery showing pulmonary embolism. Contraindications There are no known contraindications. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 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. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. The Swan-Ganz catheter was exchanged over a long V18 wire. 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 CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Use prior to the Use By date. Chris Metzger, MD 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/fibrillation; arteriovenous fistula; death; device malfunction; distal embolization; emergent surgery; false aneurysm formation; hematoma, hemorrhage, or blood loss at access site; hematoma, hemorrhage, or blood loss; hypotension; inability to completely remove thrombus or control blood flow; infection; ischemia; kidney damage from contrast media; myocardial infarction; neurological deficits including stroke; respiratory failure; thromboembolic events; vascular complications (including vessel spasm, thrombosis, intimal disruption, dissection, or perforation). The Indigo Separator 4 is not intended for use as a guidewire. 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. gtag('js', new Date()); Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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). The device is intended for single use only. 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 (CAT) are the foundation of Penumbras IndigoSystem. 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. Orange, California Due to our experience in such cases, sustained aspiration with the Indigo System CAT RX with Penumbra ENGINE has quickly become our frontline device, challenging the traditional method of manual aspiration in patients with thrombi and emboli in the coronary arteries. This content is not intended to offer professional medical advice. Maintain a constant infusion of appropriate flush solution. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. This site is protected by reCAPTCHA and the Google, 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 Intelligent Aspiration comes packaged with CAT7, CAT8 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. 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 in the presence of a flammable anesthetic mixture with air or nitrous oxide. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Figure 2. This website is intended for US audience only. 8: Add BMK6F95M-NE . Indication For Use Ultrasound-guided access was obtained through the right femoral vein. Distal emboli causing PDA occlusion after manual aspiration. Indigo Aspiration System Intended Use Initial angiogram showing high thrombus burden in the left circumflex artery. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Categories. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. suhail.dohad@cshs.org 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. 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 The CAT family of catheters is the foundation of Penumbra's Indigo System. 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. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. . System Chair, Clinical Research Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Do not use open or damaged packages. Do not block bottom air vents. There are no contraindications. Precautions Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Use prior to the Use By date. Use prior to the Use By date. Potential Adverse Events The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). 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. Waqas R. Qureshi, MD, MS . Use prior to the Use By date. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. SVG occlusions can be challenging to resolve using traditional treatment modalities. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Jolly SS, Cairns JA, Yusuf S, et al. TIMI 3 flow was achieved in 88% of cases. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. No modification of this equipment is allowed. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. function gtag(){dataLayer.push(arguments);} Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. The INDIGO SEPARATOR is not intended for use as a guidewire. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2).
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