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INDIGO Aspiration System Intended Use The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. Do not use kinked or damaged devices. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Penumbra enrols first patient in CHEETAH Study of Indigo CAT RX device 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 System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. CAT RX is an essential tool in our percutaneous coronary armamentarium. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Penumbra ENGINE Intended 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. Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight Penumbras Indigo Aspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism and/or certain central circulatory system conditions such as pulmonary emboli. Penumbra, CAT8XTORQ115, Penumbra CAT8 Indigo Aspiration Catheter, XTorq Lightning 12 and Lightning 8 expand the already broad offering of CAT8, CATD, CAT6, CAT5, and CAT3 and are paired with Penumbra ENGINE, the company's proprietary continuous, mechanical vacuum . Do not resterilize or reuse. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Saxon RR, Benenati JF, Teigen C, et al. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. Figure 2. Use prior to the Use By date. There are no contraindications. Do not use kinked or damaged devices. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. The Indigo Aspiration System is comprised of several devices: The Indigo System may be used as a first-line approach or rescue therapy for arterial and venous thrombotic events. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Do not use kinked or damaged devices. A, Penumbra Indigo System Continuous Aspiration - ResearchGate It will reduce service life of the Penumbra ENGINE. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum (-29 inHg or 98.2 kPa) to our catheters, enabling thrombus removal in vessels of various sizes. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. Do not use in oxygen rich environment. Distal emboli causing PDA occlusion after manual aspiration. 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 . 2015;372:1389-1398. Otherwise, this could result in degradation of the performance of this equipment. 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. 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. 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. Potential Adverse Events Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. Maintain a constant infusion of appropriate flush solution. 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. 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. Mechanical Aspiration Thrombectomy Using the Penumbra CAT RX - PubMed Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. gtag('js', new Date()); Do not block bottom or back air vents. SciELO - Brasil - Suporte mecnico extracorpreo e trombectomia por CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Do not re-infuse blood or fluid from the canister back into the patient. The device is intended for single use only. The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: Indigo System - Vascupedia Do not use open or damaged packages. 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 If the cause cannot be determined, withdraw the device or system as a unit. Potential Adverse Events . Do not use in an oxygen rich environment. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. The CAT family of catheters is the foundation of Penumbra's Indigo system. 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. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Further evaluation of the returned device revealed kinks in the catheter shaft. 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 device is intended for single use only. N Engl J Med. 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. Separator 8, 150 cm Length, 0.072 in. K180412. Potential Adverse Events There was partial improvement of flow, but total occlusion remained. 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. 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. Sista A. Indigo aspiration system for acute pulmonary embolism. INDIGO Aspiration Tubing: 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 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. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. 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 Indigo Aspiration System is contraindicated in: Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Do not use open or damaged packages. Learn more about Lightning. 5, 21. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 0, 23. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. Do not use in an oxygen rich environment. Medical Director, Aortic Disease and Ischemic Limb Disease Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . Innovation in Coronary Mechanical Thrombectomy: Indigo System CAT RX Contraindications Penumbra Cat 8 - IndiaMART Alameda, CA 94502. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. 22. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. 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. 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. Next Article 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. Copyright 2023 Penumbra, Inc. All rights reserved. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). Copyright 2022 Penumbra, Inc. All rights reserved. The CAT family of catheters is the foundation of Penumbra's Indigo System. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Indigo System Catheters & Separators | Penumbra Inc Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Return all damaged devices and packaging to the manufacturer/ distributor. Figure 3. Warnings Copyright 2023 Penumbra, Inc. All rights reserved. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Contraindications There are no known contraindications. Additional Details. Do not use open or damaged packages. SVG occlusions can be challenging to resolve using traditional treatment modalities. Aspiration Tubing Intended Use Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Units in stock: 1. TIMI 3 flow was achieved in 88% of cases. Distal OD. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). Penumbra Announces U.S. Commercial Availability of INDIGO System Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. This website is intended for US audience only. The means of mains disconnect is to remove the power cord. 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 Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. Jolly SS, Cairns JA, Lavi S, et al. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Orange, California 2: Add Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. Related Items. 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. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 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. 510(k) Premarket Notification - Food And Drug Administration 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). Giri J, Sista AK, Weinberg J, et al. Figure 1. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. If the cause cannot be determined, withdraw the device or system as a unit. 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. Conclusions: evaluation of the cat8 revealed that the device was fractured. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. 1. The cat8 was kinked approximately 69. Contraindications There are no known contraindications. Worcester, Massachusetts If the cause cannot be determined, withdraw the device or system as a unit. Penumbra, CAT8TORQ85, Penumbra CAT8 Indigo Aspiration Catheter, Torq PENUMBRA ENGINE Intended Use The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Copyright 2022 Penumbra, Inc. All rights reserved. After one pass with CAT RX, the initial occlusion was removed. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. Copyright 2022 Penumbra, Inc. All rights reserved. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. The Indigo System utilises the Penumbra ENGINE aspiration source capable of delivering nearly pure, continuous vacuum (-29 inHg or 98.2 kPa) to our catheters, enabling thrombus removal in vessels of various sizes. University of Massachusetts Medical School 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). 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. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. 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. 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; The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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 lower . 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 . As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 (Penumbra, Inc.) are indicated for the removal of fresh soft emboli and thrombi from vessels in the coronary and peripheral vasculature. BJC Cardiology 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. 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 . PENUMBRA: SEP8 - Westcmr.com Director of Cardiac & Peripheral Cath Lab When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Do not use kinked or damaged devices. This warranted the need for further innovation in the field of acute coronary syndrome.2 The goal of the Indigo System CAT RX mechanical aspiration system powered by the Penumbra ENGINE is to provide sustained aspiration for the duration of the procedure with enhanced deliverability to navigate tortuous anatomy and track to the distal coronary vasculature. Do not use open or damaged packages. Relying on a different mechanism of action, power aspiration with CAT RX and Penumbra ENGINE was able to extract the thrombus intact; thus restoring flow through the graft. Photo: Courtesy of Business Wire. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Jawairia Sahar K. Mirza, MBBS Lightning Flash: The Most Powerful and Advanced Mechanical Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. 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. 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 following case reports highlight CAT RX in a multitude of unique applications as a primary frontline device to treat patients with high thrombus burden. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Categories. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Los Angeles, California A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The CAT familyof catheters is the foundation of Penumbras Indigo System. 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. 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 . 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. Thrombectomy & Embolization | Vascular Medical Devices - Penumbra Inc Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Famous Characters Named Grace, Articles C

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