The CAT8 is indicated for removal of emboli and thrombi from the peripheral . Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. Worcester, Massachusetts The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. The INDIGO SEPARATOR is not intended for use as a guidewire. Penumbra Indigo System | Vascular Thrombectomy Return all damaged devices and packaging to the manufacturer/distributor. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. Control angiography immediately after thrombectomy demonstrated restored patency . SVG occlusions can be challenging to resolve using traditional treatment modalities. 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. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). Penumbra's Newest Generation of Indigo Aspiration System Receives FDA suhail.dohad@cshs.org The device is intended for single use only. Use prior to the Use By date. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. Contraindications Not for use in the coronaries or the neurovasculature. 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). This website is intended for US audience only. INDIGO Aspiration System Intended Use 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. Figure 2. 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. Created with Sketch. J Vasc Interv Radiol. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. Do not reuse. It will reduce the service life of the PENUMBRA ENGINE. UMassMemorial University Campus Contraindications There are no known contraindications. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. 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 . 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. The CAT family of catheters is the foundation of Penumbra's Indigo System. 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 . With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Director of Cardiac & Peripheral Cath Lab Final angiogram after stent placement showing resolution of underlying disease. 2. There was partial improvement of flow, but total occlusion remained. 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 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. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Penumbra, CAT8TORQ85, Penumbra CAT8 Indigo Aspiration Catheter, Torq 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. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Contraindications 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. Indigo System Intended Use Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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. 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. Director, Structural Heart It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. Possible complications include, but are not limited to, the following: Director of Cardiac Catheterization Lab, PERT & Structural Heart When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Figure 2. The Indigo System CAT RX with Penumbra ENGINE is an invaluable tool that is easy to set up and can provide rapid thrombectomy and immediate reperfusion. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . The Swan-Ganz catheter was exchanged over a long V18 wire. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 Distal emboli causing PDA occlusion after manual aspiration. Two passes of CAT RX with the Penumbra ENGINE resulted in TIMI 3 flow restoration and retrieval of the distal emboli from the PDA (Figure 3). Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Copyright 2022 Penumbra, Inc. All rights reserved. Do not block bottom air vents. Vascular Thrombectomy. Maintain a constant infusion of appropriate flush solution. Penumbra Augments Vascular Franchise with Latest Indigo System Launch The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). The low-profile catheter and Penumbra . CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. Throughout each case, Lightning provides procedural feedback via audio visual cues. Do not resterilize or reuse. Chris Metzger, MD Rethinking Thrombus Removal With the Indigo System: Introducing 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Categories. Penumbra enrols first patient in CHEETAH Study of Indigo CAT RX device Brian Kolski, MD Figure 1. S. Jay Mathews, MD, MS, FACC No modification of this equipment is allowed. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . 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. Mechanical Thrombectomy | Medical Billing and Coding Forum - AAPC right-arrow When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Do not use in an oxygen rich environment. 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. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 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. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Bradenton Cardiology Center/Manatee Memorial Hospital 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; Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . Innovation in Coronary Mechanical Thrombectomy: Indigo System CAT RX window.dataLayer = window.dataLayer || []; Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . 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. Gus Theodos, MD, FACC, FSCAI 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. gtag('js', new Date()); 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 . Mechanical clot engagement with proprietary Separator technology, Tip directionality for circumferential aspiration, The Indigo System is an integrated system for use only with other components of the Indigo System including the CAT family of catheters, Separators, Dynamic Aspiration Tubing, Lightning, Penumbra ENGINE, and Penumbra ENGINE Canister, Lightning Computer-Aided Aspiration comes packaged with CAT7 or CAT12, Live feedback during the procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister. Indigo System - Vascupedia Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. The product-specific content of this website is intended for use by healthcare professionals only. 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. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. Warnings/Precautions Return all damaged devices and packaging to the manufacturer/distributor. Figure 2. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. 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. Equipment is not safe for MR use. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. This website is intended for US audience only. 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. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. 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. After one pass with mechanical thrombectomy using CAT RX, the thrombus was removed and flow was restored to the pedal arch via the plantar posterior tibial artery (Figure 2 and Figure 3). PENUMBRA: SEP8 - Westcmr.com We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. Precautions The device is intended for single use only. Utility of a power aspiration-based extraction technique as an initial and secondary approach in the treatment of peripheral arterial thromboembolism: results of the multicenter PRISM Trial. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. TIMI 3 flow was achieved in 88% of cases. In our practice, we have been able to more accurately define percutaneous transluminal coronary angioplasty and stent length as a result of this increased visualization. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. Do not block bottom or back air vents. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The treatment of arterial and venous thrombus is challenging. Penumbra Aspiration Pump: 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. INDIGO Aspiration Catheters and Separators: Applicant. PENUMBRA ENGINE Intended Use chronic clot, atherosclerotic plaque) The low-profile catheter and Penumbra ENGINE are easy to set up and use. Do not use open or damaged packages. 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. Indigo System CAT RX tracking through the distal posterior tibial artery. Mechanical Aspiration Thrombectomy Using the Penumbra CAT RX - PubMed The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. Jolly SS, Cairns JA, Yusuf S, et al. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. This is potentially more effective than diminished syringe-based aspiration. Otherwise, this could result in degradation of the performance of this equipment. 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. Mathews SJ, Brown C, Kolski B, et al. Do not resterilize or reuse. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. 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. Penumbra Recalls JET 7 Catheters with Xtra Flex -Risk of Mortality Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. INDIGO System LIGHTNING Aspiration Tubing Intended 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. 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. Lightning comes packaged with the Indigo CAT7 or CAT12. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . J Am Coll Cardiol. window.dataLayer = window.dataLayer || []; The CAT family of catheters is the foundation of Penumbras Indigo System. Penumbra CAT6, Indigo system Aspiration Catheter 6F, 135cm - MedicalEcart 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). 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 . The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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. After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. 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. Because the patient was not a candidate for thrombolysis, the decision was made to intervene with the Indigo System CAT8XTORQ115 and SEP 8, which were advanced sequentially into the right then left pulmonary artery. 3. 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. 1. 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. 5, 19. 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 Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Disclosures: None. Mechanical thrombectomy was performed. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. 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. Copyright 2023 Penumbra, Inc. All rights reserved. The procedure was completed with the same catheter. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Maintain a constant infusion of appropriate flush solution. CAT RX has allowed us to rethink how we approach these occluded SVGs. 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. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. 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 . function gtag(){dataLayer.push(arguments);} The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 510(k) Premarket Notification - Food And Drug Administration 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. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. 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. Mechanical Thrombectomy. Disclosures: Consultant to Penumbra, Inc. A 75-year-old woman with a history of diabetes, hypertension, and dyslipidemia presented with Rutherford class 5 critical limb ischemia (CLI) due to a nonhealing ulcer. Los Angeles, California Final angiogram after mechanical thrombectomy with CAT8 and SEP8. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. There were no cases of 30-day cardiovascular death or post procedural stroke. Do not use open or damaged packages. Kingsport, Tennessee . Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. 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 patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. 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). left-arrow Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. The means of mains disconnect is to remove the power cord. Distal posterior tibial artery emboli occlusion. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. 0 cm from the hub. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . To prevent fire or shock hazard, use a replacement power cord of equal rating. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. 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. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. 2018;72:1589-1596. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. Randomized trial of primary PCI with or without routine manual thrombectomy. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. Do not use kinked or damaged devices. 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. 2023 Bryn Mawr Communications II, LLC. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. 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 . Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F(x) 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.