cat8 penumbra catheter

Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. QUICK VIEW. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. We expect the results to further refine and improve our technique for mechanical aspiration and fine-tune the use of CAT RX for patients with high thrombus burden. SVG occlusions can be challenging to resolve using traditional treatment modalities. 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. Jolly SS, Cairns JA, Yusuf S, et al. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Final angiographic result of SVG. 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 Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. . 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Otherwise, this could result in degradation of the performance of this equipment. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. 2. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. 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.). Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. 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 the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. 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. UMassMemorial University Campus This website is intended for US audience only. The device is intended for single use only. 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. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. Jolly SS, Cairns JA, Lavi S, et al. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Potential Adverse Events There are no contraindications. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. CAT8XTORQ115KIT-NS. Initial angiography revealed an occlusion of the distal RCA. The Indigo Separator 4 is not intended for use as a guidewire. . Separator 8, 150 cm Length, 0.072 in. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). Prior to use, please consult device labeling and instructions for use. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. 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. Initial angiogram showing high thrombus burden in the left circumflex artery. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. 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 angiogram showing high thrombus burden in the RCA. 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. 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. 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. With the maximized inner diameter of 0.082 and a 7 French outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. The product-specific content of this website is intended for use by healthcare professionals only. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. PENUMBRA ENGINE Indication for Use 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. The means of mains disconnect is to remove the power cord. The CAT family of catheters is the foundation of Penumbra's Indigo System. 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. Control angiography immediately after thrombectomy demonstrated restored patency . The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. gtag('js', new Date()); No modification of this equipment is allowed. Jawairia Sahar K. Mirza, MBBS The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Copyright 2022 Penumbra, Inc. All rights reserved. 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 2023 Penumbra, Inc. All rights reserved. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. The Indigo Aspiration System is contraindicated in: If the cause cannot be determined, withdraw the device or system as a unit. The complaint indicated that the cat8 was kinked during the procedure. The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. Contraindications There are no known contraindications. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Return all damaged devices and packaging to the manufacturer/distributor. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Latest System Designed for Single Session Arterial Thrombus Removal News 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. 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. function gtag(){dataLayer.push(arguments);} 2018;72:1589-1596. 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 . No conversations found. 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. INDIGO Aspiration Catheters and Separators: Copyright 2022 Penumbra, Inc. All rights reserved. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Do not use open or damaged packages. 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. 5, 19. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. S. Jay Mathews, MD, MS, FACC 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. 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. 1. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). These data are encouraging and have led to the next stage in data collection through the CHEETAH studya 400-patient, prospective, observational study evaluating the initial safety and performance of the Indigo Aspiration System CAT RX. The device is intended for single use only. Potential Adverse Events 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. Potential Adverse Events When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Power aspiration with CAT RX has allowed us to successfully remove thrombus in patients presenting with acute coronary syndrome, establishing quick distal reperfusion and also visualization of the underlying stenosis. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . 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. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Copyright 2023 Penumbra, Inc. All rights reserved. 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 LIGHTNING Aspiration Tubing. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The penumbra cat8 indigo system (cat8) was kinked approximately 4. Results of EXTRACT-PE Trial presented at Vascular InterVentional Advances (VIVA) Annual Meeting Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced that the EXTRACT-PE trial successfully met the primary endpoints, demonstrating the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with . 2023 Bryn Mawr Communications II, LLC. 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. suhail.dohad@cshs.org Return all damaged devices and packaging to the manufacturer/distributor. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. This content is not intended to offer professional medical advice. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. The pulmonary capillary wedge pressure is 10 mmHg. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. 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. 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. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. Contraindications There are no contraindications. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 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. Medical Director, Aortic Disease and Ischemic Limb Disease UPC: Current Stock: This item is out of stock. The cat8 was kinked approximately 69. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 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; We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. Do not block bottom or back air vents. 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. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Penumbra ENGINE. These pages are not intended for patients or for members of the general public. Return all damaged devices and packaging to the manufacturer/ distributor. After one pass with CAT RX, the initial occlusion was removed. 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 . Suhail Dohad, MD, FACC Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. Do not resterilize or reuse. 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. 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. Distal OD. 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 in an oxygen rich environment. The device is intended for single use only. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Catheters & Separators. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. To prevent fire or shock hazard, use a replacement power cord of equal rating. 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). Potential Adverse Events 0, and 37. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. INDIGO Aspiration System Intended Use Penumbra's high-performance aspiration catheters. Mechanical Thrombectomy. 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. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 0, 24. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . 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. PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8 DXE: Back to Search Results: Model Number CAT8XTORQ115KIT-S: Device Problems Break (1069); Physical Resistance/Sticking (4012) Patient Problem No Clinical Signs, Symptoms or Conditions (4582) Event Date 05/19/2021: Do not use open or damaged packages. 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. 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 patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. Los Angeles, California Figure 3. 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. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. sjaymathewsmd@gmail.com Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. 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. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Use prior to the Use By date. 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 patient had a robust recovery and was discharged to her rehab facility on anticoagulation. The Indigo System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. 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 . With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. She was in a rehab facility prior to this new event recovering from her CVA. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. The results may vary depending on a variety of patient specific attributes. Return all damaged devices and packaging to the manufacturer/distributor. PENUMBRA ENGINE Intended Use Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: Learn more about Lightning. Not for use in the coronaries or the neurovasculature. 1. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. 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. 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. Do not re-infuse blood or fluid from the canister back into the patient. Otherwise, this could result in degradation of the performance of this equipment. The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum to our catheters to remove thrombus in vessels of various sizes. Use prior to the Use By date. gtag('js', new Date()); In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon 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. 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. Warnings 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. System Chair, Clinical Research 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Penumbra ENGINE Intended Use Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 1. Aspiration Tubing Intended Use 1. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Mathews SJ, Brown C, Kolski B, et al. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Worcester, Massachusetts Figure 2. Do not use kinked or damaged devices. The cerebral vasculature The low-profile catheter and Penumbra . Penumbra's not relying on software alone. 5 and 94. Prior to use, please consult device labeling and instructions for use. J Vasc Interv Radiol. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. This is potentially more effective than diminished syringe-based aspiration. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Bradenton Cardiology Center/Manatee Memorial Hospital The CAT family of catheters is the foundation of Penumbra's Indigo system. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. Do not use in oxygen rich environment. Penumbras IndigoAspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. 2017;377:2240-2252. This press release features multimedia. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. LIGHTNING Aspiration Tubing Indication for Use 2: Add 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. Equipment is not safe for MR use. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 0, 23. Precautions The device is intended for single use only. Initial angiogram of the right pulmonary artery showing pulmonary embolism. 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. After IVUS, the stent was dilated to 3.75 mm. Figure 2. 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 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.

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