cat8 penumbra catheter

Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. After one pass with CAT RX, the initial occlusion was removed. CAT7 and CAT12 are the next generation of the Indigo System catheters. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. The canister is intended for single use only. The Indigo System and CAT8 - Endovascular Today 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);} In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 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. Interventional Cardiology If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. 2015;372:1389-1398. Distal emboli causing PDA occlusion after manual aspiration. Do not resterilize or reuse. 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. 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 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. 3. These types of burns heal withing 5 or 6 days without permanent scarring. Maintain a constant infusion of appropriate flush solution. Return all damaged devices and packaging to the manufacturer/distributor. The cerebral vasculature The product-specific content of this website is intended for use by healthcare professionals only. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Do not use in 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. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION Jolly SS, Cairns JA, Lavi S, et al. Penumbra Announces U.S. Commercial Availability of INDIGO System UPC: Current Stock: This item is out of stock. The Penumbra Aspiration Pump is indicated 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. Use prior to the Use By date. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . Circulation. Potential Adverse Events If the cause cannot be determined, withdraw the device or system as a unit. Catheters & Separators. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. Enter your email address and we will contact you. Final angiographic result of SVG. Precautions The device is intended for single use only. 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. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Next Article 2023 Bryn Mawr Communications II, LLC. 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 . This content is not intended to offer professional medical advice. . When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. We presented our initial experience at the American College of Cardiologys (ACC) 68th Annual Scientific Session, which showed promising results for mechanical power aspiration for thrombus removal during percutaneous intervention using CAT RX.3 This retrospective case series included 59 patients from four institutions around the United States. Indication For Use This content is not intended to offer professional medical advice. 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. IN-DATE. Penumbra, Inc. One Penumbra Place. The device is intended for single use only. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. J Vasc Interv Radiol. Figure 1. The system uses Penumbra's RED reperfusion catheters. S. Jay Mathews, MD, MS, FACC The Penumbra CAT RX catheter was used in a total of 34 patients, with 71% STEMI, 23% NSTEMI, 3% UA, and 3% new onset heart failure. 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. 3. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 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. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. . Copyright 2023 Penumbra, Inc. All rights reserved. Photo: Courtesy of Business Wire. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: 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. 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. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Copyright 2022 Penumbra, Inc. All rights reserved. Mathews SJ, Brown C, Kolski B, et al. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Equipment is not safe for MR 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. Warnings Penumbra Augments Vascular Franchise with Latest Indigo System Launch An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. Contraindications There are no known contraindications. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Catheters - Aspiration Catheters - Page 1 - Medical Materials Figure 3. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. 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. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . 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 product-specific content of this website is intended for use by healthcare professionals only. Indigo System | Computer-Aided Mechanical Aspiration. CAT7 and CAT12 are the next generation of the Indigo System Catheters. 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). Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Initial angiography revealed an occlusion of the distal RCA. Do not re-infuse blood or fluid from the canister back into the patient. 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. 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). To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 0, 26. CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing Precautions The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. The CAT family of catheters is the foundation of Penumbras Indigo System. INDIGO Aspiration System Intended Use Return all damaged devices and packaging to the manufacturer/ distributor. Figure 1. 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. She was in a rehab facility prior to this new event recovering from her CVA. Do not use in an oxygen rich environment. Distal OD. Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. The CAT family of catheters is the foundation of Penumbra's Indigo system. Bradenton Cardiology Center/Manatee Memorial Hospital INDIGO Aspiration Tubing: function gtag(){dataLayer.push(arguments);} The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Orange, California Pela bainha, foi introduzido o dispositivo de aspirao Penumbra Indigo System CAT8 XTORQ (Penumbra Inc., Alameda, Califrnia, Estados Unidos) em trombo segmentar, lobar ou arterial pulmonar principal, sendo realizada aspirao contnua (Figuras 2 e 3). 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 . Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. 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. suhail.dohad@cshs.org 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. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Indigo System CAT RX tracking through the distal posterior tibial artery. Director of Cardiac & Peripheral Cath Lab K180412. Contraindications Not for use in the coronaries or the neurovasculature. Indigo System | Penumbra Inc How Penumbra's smart-sucking algorithms and catheters speed up clot 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. 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. Maintain a constant infusion of appropriate flush solution. 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. 0, and 37. 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.). These pages are not intended for patients or for members of the general public. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. Penumbra Indigo Aspiration System IDE Trial for Acute Pulmonary Latest System Designed for Single Session Arterial Thrombus Removal News The procedure can be performed quickly,1 which is important for symptomatic patients. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . It will reduce service life of the Penumbra ENGINE. SVG occlusions can be challenging to resolve using traditional treatment modalities. Available in a selection of sizes, the CAT family can provide access to distal peripheral . To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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. Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. Gus Theodos, MD, FACC, FSCAI Use only waterbased solvents for cleaning. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. The advantages of CAT RX with Penumbra ENGINE include the potential to remove the thrombus intact and reduce the potential of systemic embolization while also increasing the visualization of the underlying stenosis and distal vessel. 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. Figure 3. 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. 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. Contraindications Sista A. Indigo aspiration system for acute pulmonary embolism. 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. Additional Details. Penumbra's high-performance aspiration catheters. Vascular Thrombectomy. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. If the cause cannot be determined, withdraw the device or system as a unit. Do not re-infuse blood or fluid from the canister back into the patient. 1. 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. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). 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. gtag('js', new Date()); 5, 21. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. 2. 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. Figure 2. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Warnings/Precautions The canister is intended for single use only. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. The INDIGO SEPARATOR is not intended for use as a guidewire. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. Figure 1. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove 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. This website is intended for US audience 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. window.dataLayer = window.dataLayer || []; Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. (CAT3, CAT RX, CAT5, CAT6, CAT8, and CATD) and patented Separator technology, which maintains continuous aspiration and helps limit clogging of the catheters tip during the procedure. UPC: Current Stock: . The Swan-Ganz catheter was exchanged over a long V18 wire. Categories. Missouri Baptist Medical Center Use only water-based solvents for cleaning. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. 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. To prevent fire or shock hazard, use a replacement power cord of equal rating. left-arrow Kingsport, Tennessee University of Massachusetts Medical School 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 patient had a robust recovery and was discharged to her rehab facility on anticoagulation. 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. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Cedars Sinai Medical Center The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Aspiration Tubing Intended Use Penumbra aspiration assistance | Medical Billing and Coding Forum - AAPC Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Saxon RR, Benenati JF, Teigen C, et al. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. All Rights Reserved Privacy Policy, With S. Jay Mathews, MD, MS, FACC; Chris Metzger, MD; Waqas R. Qureshi, MD, MS; Jawairia Sahar K. Mirza, MBBS; Gus Theodos, MD, FACC, FSCAI; Brian Kolski, MD; Suhail Dohad, MD, FACC. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. Control angiography immediately after thrombectomy demonstrated restored patency . gus.theodos@bjc.org; @gtheodosmd Penumbra System Products - Medical Materials System Chair, Clinical Research 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. 2: Add Copyright 2023 Penumbra, Inc. All rights reserved. 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. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Do not use open or damaged packages. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: .

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