The product-specific content of this website is intended for use by healthcare professionals only. Figure 1. 2015;372:1389-1398. An Interview With Binita Shah, MD, MS, FACC, FSCAI, By Mansi Oberoi, MD; M. Chadi Alraies, MD; and Poonam Velagapudi, MD, MS, Left Main Disease and Bifurcation Revascularization in Female Patients, By Tara L. Jones, MD, PharmD, and Valeria Paradies, MD, By Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, Applying Team-Based Care Delivery to Interventional Cardiology: Learnings from the 2022 MedAxiom CV APP Survey, Understanding Sex Differences in Acute and Chronic Coronary Syndromes, By F. Aaysha Cader, MBBS, MD, MRCP(UK), MSc(Oxon); Rudaynah Amein Alali, MBBS, Internal Medicine Board, Interventional Cardiology Fellowship, RCPI; and Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, SuperSaturated Oxygen Therapy: Cases and Cocktails Event Winning Presentations, With Charishma Nallapati, MD; Amer N. Kadri, MD; James Richard Spears, MD; Zaid Al-Jebaje, MD; Babar Basir, DO; and Khaldoon Alaswad, MD, FACC, FSCAI. Do not use open or damaged packages. St. Joseph Hospital Indigo Aspiration System Intended Use Brandenton, Florida Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. Worcester, Massachusetts 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. Disclosures: None. 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. Copyright 2023 Penumbra, Inc. All rights reserved. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. The pulmonary capillary wedge pressure is 10 mmHg. 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. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. The INDIGO SEPARATOR is not intended for use as a guidewire. The CAT family of catheters is the foundation of Penumbra's Indigo System. Do not use kinked or damaged devices. 0, 23. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. 1. J Am Coll Cardiol. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. 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. 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. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. 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. Equipment is not safe for MR use. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. If the cause cannot be determined, withdraw the device or system as a unit. 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. 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. Final angiogram showing resolution of extensive thrombus burden. Warnings/Precautions Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. 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. The low-profile catheter and Penumbra ENGINE are easy to set up and use. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. window.dataLayer = window.dataLayer || []; The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Penumbra Aspiration Pump: 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 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. Maintain a constant infusion of appropriate flush solution. N Engl J Med. Copyright 2022 Penumbra, Inc. All rights reserved. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Use only water-based solvents for cleaning. 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. Maintain a constant infusion of appropriate flush solution. BJC Cardiology Manual aspiration suffers from diminished aspiration force as fluid fills in the syringe, potentially resulting in systemic embolization during catheter removal, as shown in the TOTAL trial published in 2015 (Figure 1).1 Subgroup analysis of patients with high thrombus burden was explored that highlighted the potential for improved outcomes. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. 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. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. 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. Distal posterior tibial artery emboli occlusion. 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. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. 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. 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. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. These pages are not intended for patients or for members of the general public. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. 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. The product-specific content of this website is intended for use by healthcare professionals only. There were no cases of 30-day cardiovascular death or post procedural stroke. 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. Figure 2. System Chair, Clinical Research Vedantham S, Goldhaber SZ, Julian JA, et al. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Do not use open or damaged packages. 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. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. 0, 26. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. These pages are not intended for patients or for members of the general public. In a retrospective analysis of patients in our practice with fresh thrombus burden, we have observed TIMI 3 restored when using CAT RX frontline.1 This is another positive patient outcome with the use of CAT RX in a case of high thrombus burden. 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. 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. Saint Louis, Missouri INDIGO Aspiration Tubing: 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. function gtag(){dataLayer.push(arguments);} Available in a selection of sizes, the CAT family can provide access to distal peripheral . Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Return all damaged devices and packaging to the manufacturer/ distributor. After one pass with CAT RX, the initial occlusion was removed. 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. (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. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. . The procedure was completed with the same catheter. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Conclusions: evaluation of the cat8 revealed that the device was fractured. 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 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. Mathews SJ, Brown C, Kolski B, et al. The device is intended for single use only. Do not use kinked or damaged devices. Contraindications Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. 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. Otherwise, this could result in degradation of the performance of this equipment. Created with Sketch. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Penumbra's high-performance aspiration catheters. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. Precautions The device is intended for single use only. Do not re-infuse blood or fluid from the canister back into the patient. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 510 (k) Number. The procedure can be performed quickly,1 which is important for symptomatic patients. Initial angiography revealed an occlusion of the distal RCA. Do not use kinked or damaged devices. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Possible complications include, but are not limited to, the following: 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. Alameda, CA 94502. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Copyright 2023 Penumbra, Inc. All rights reserved. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Director, Structural Heart Created with Sketch. 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 advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. 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. 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. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). Indication For Use LIGHTNING Aspiration Tubing Indication for Use To prevent fire or shock hazard, use a replacement power cord of equal rating. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . Figure 1. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. Return all damaged devices and packaging to the manufacturer/distributor. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. Device Name. Order Qty. Separator 8, 150 cm Length, 0.072 in. This website is intended for US audience only. Potential Adverse Events Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. Figure 2. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. Do not resterilize or reuse. 2023 Bryn Mawr Communications II, LLC. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. gtag('js', new Date()); Figure 1. 2. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Use prior to the Use By date. 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. Return all damaged devices and packaging to the manufacturer/distributor. . Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Units in stock: 1. The Indigo Aspiration System is contraindicated in: Penumbra Aspiration Pump: CAT RX is an essential tool in our percutaneous coronary armamentarium. CAT7 and CAT12 are the next generation of the Indigo System Catheters. Los Angeles, California Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . 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 Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. 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. INDIGO Aspiration Catheters and Separators: Do not resterilize or reuse. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . Indigo System | Computer-Aided Mechanical Aspiration. 5 and 94. 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. 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. Do not resterilize or reuse. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. 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. 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. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. UPC: Current Stock: This item is out of stock. 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. Penumbra's CAT family of catheters is engineered to be robust, trackable, atraumatic, and well suited to the peripheral anatomy where clots can form in long segments. If the cause cannot be determined, withdraw the device or system as a unit. Do not use in oxygen rich environment. Next Article The cerebral vasculature Saxon RR, Benenati JF, Teigen C, et al. Contraindications There are no known contraindications. The system uses Penumbra's RED reperfusion catheters. Aspiration Tubing Intended Use The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. 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. Precautions The device is intended or single use only. 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. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30 cm) to any part of the PENUMBRA ENGINE. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. The large aspiration lumen and highly trackable, low-profile design coupled with the power of the Penumbra ENGINE resulted in the successful removal of the emboli in one pass. The results may vary depending on a variety of patient specific attributes. The Swan-Ganz catheter was exchanged over a long V18 wire. Precautions The canister is intended for single use only. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Use only waterbased solvents for cleaning. 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. These types of burns heal withing 5 or 6 days without permanent scarring. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. Catheters & Separators. Do not use in oxygen rich environment. 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. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. kolskiwellness@gmail.com Unit may overheat and shut off or fail to restart if run for extended periods without airflow. Copyright 2022 Penumbra, Inc. All rights reserved. Gus Theodos, MD, FACC, FSCAI It will reduce service life of the Penumbra ENGINE. Potential Adverse Events Interventional Cardiology Do not resterilize or reuse. 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). The complaint indicated that the cat8 was kinked during the procedure. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Contraindications There are no contraindications. Use prior to the Use By date. 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 . Figure 2. 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 . Learn more about Lightning. Maintain a constant infusion of appropriate flush solution. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. The pain became more intense and constant, so he presented to the ED. Indigo System Intended Use Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. J Vasc Interv Radiol. The Indigo System Catheter CAT8 was used across 22 sites in the United States in patients with submassive PE who did not receive thrombolytics (98.3%), with a . The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. It will reduce the service life of the PENUMBRA ENGINE. 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. Throughout each case, Lightning provides procedural feedback via audiovisual cues. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration.