cat8 penumbra catheter

Contraindications There are no contraindications. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 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 Conclusions: evaluation of the cat8 revealed that the device was fractured. 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. Orange, California CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. Jawairia Sahar K. Mirza, MBBS Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). 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. Categories. 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). Indigo System CAT RX tracking through the distal posterior tibial artery. 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. Created with Sketch. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Use only water-based solvents for cleaning. 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. Return all damaged devices and packaging to the manufacturer/distributor. $399.00 EACH. 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. Final angiogram with complete TIMI 3 flow after the use of CAT RX. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . Penumbra Aspiration Pump: Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. 2. Do not use kinked or damaged devices. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Disclosures: None. sjaymathewsmd@gmail.com Contraindications 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. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Initial angiogram showing high thrombus burden in the left circumflex artery. 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 . Mechanical thrombectomy was performed. Los Angeles, California Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Suhail Dohad, MD, FACC The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. The CAT family of catheters is the foundation of Penumbras Indigo System. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. Penumbra, a US-based provider of advanced therapies, has enrolled the first patient into the CHEETAH clinical study, designed to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. Figure 3. Do not use open or damaged packages. Warnings Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Distal posterior tibial artery emboli occlusion. The Indigo Separator 4 is not intended for use as a guidewire. 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. 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 . Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Latest System Designed for Single Session Arterial Thrombus Removal News The pulmonary capillary wedge pressure is 10 mmHg. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Figure 2. 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. Flow through left circumflex artery post-CAT RX. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Vedantham S, Goldhaber SZ, Julian JA, et al. Device Name. 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 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. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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. 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. gtag('js', new Date()); Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. 5, 19. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. . 3D, 3D Revascularization Device, ACE, Artemis, BENCHMARK, CAT, Indigo, LANTERN, Lightning, MAX, Neuron, Neuron MAX, Penumbra Coil 400, Penumbra ENGINE, Penumbra P logos, Penumbra System, Penumbra SMART COIL, POD, PX SLIM, Ruby, Select, Separator, Velocity, and WAVE are all registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. Physicians in the USA have published details ofto their knowledgethe "first reported use" of the Indigo aspiration system (Penumbra) to treat cerebral venous sinus thrombosis (CVST) via endovascular thrombectomy.The treated patient underwent successful partial recanalisation of the superior sagittal sinus (SSS) and bilateral transverse sinuses (TS), and experienced . Related Items. This content is not intended to offer professional medical advice. Do not use kinked or damaged devices. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. 5, 21. The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. 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. 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. This content is not intended to offer professional medical advice. The complaint indicated that the cat8 was kinked during the procedure. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. This website is intended for US audience only. 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. Prior to use, please consult device labeling and instructions for use. 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. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. 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. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. There were no cases of 30-day cardiovascular death or post procedural stroke. Do not use open or damaged packages. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. UPC: Current Stock: This item is out of stock. Do not resterilize or reuse. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. Figure 2. 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. 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. Contraindications When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. 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. 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. 2017;377:2240-2252. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon 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 CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. The product-specific content of this website is intended for use by healthcare professionals only. The INDIGO Aspiration Tubing: 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; 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 use open or damaged packages. QUICK VIEW. 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. The CAT familyof catheters is the foundation of Penumbras Indigo System. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. These pages are not intended for patients or for members of the general public. Precautions The device is intended or single use only. Bradenton Cardiology Center/Manatee Memorial Hospital After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. left-arrow This content is not intended to offer professional medical advice. Do not use kinked or damaged devices. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. 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. Worcester, Massachusetts Possible complications include, but are not limited to, the following: Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Do not resterilize or reuse. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. Separator 8, 150 cm Length, 0.072 in. 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 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; and Suhail Dohad, MD, FACC. Additional Details. 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. Missouri Baptist Medical Center The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Figure 1. Further evaluation of the returned device revealed kinks in the catheter shaft. 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. Copyright 2023 Penumbra, Inc. All rights reserved. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. Final angiogram after stent placement showing resolution of underlying disease. Cedars Sinai Medical Center 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. Aspiration Tubing Intended Use Penumbra's Indigo Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Warnings/Precautions Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Learn more about Lightning. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. Use prior to the Use By date. The means of mains disconnect is to remove the power cord. Equipment is not safe for MR use. 2018;72:1589-1596. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Kingsport, Tennessee gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Copyright 2022 Penumbra, Inc. All rights reserved. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. Disclosures: None. Do not use petroleum based 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. 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. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). function gtag(){dataLayer.push(arguments);} Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. The newest indication for the Indigo System is the treatment of pulmonary embolism; this indication comes on the heels of the promising results of the EXTRACT-PE trial. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. No conversations found. Penumbra ENGINE Intended Use The INDIGO SEPARATOR is not intended for use as a guidewire. gtag('js', new Date()); 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. After one pass with CAT RX, the initial occlusion was removed. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. Figure 2. 2018;29:92-100. Figure 1. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . 0, 26. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . 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. Chris Metzger, MD excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . 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. 5 and 94. Precautions The device is intended for single use only. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Randomized trial of primary PCI with or without routine manual thrombectomy. 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. The low-profile catheter and Penumbra ENGINE are easy to set up and use. 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. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. System Chair, Clinical Research 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. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. Circulation. Potential Adverse Events 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; 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. 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. The cerebral vasculature Do not resterilize or reuse. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. 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). University of Massachusetts Medical School . 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. 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. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. Ultrasound-guided access was obtained through the right femoral vein. Figure 2. Do not use in oxygen rich environment. K180412. Indigo Aspiration System Intended Use Do not use in an oxygen rich environment. 0 cm from the hub. 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. 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. 1. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. After IVUS, the stent was dilated to 3.75 mm. 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. Indication For Use 8: Add BMK6F95M-NE . Enter your email address and we will contact you. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. CAT8XTORQ115KIT-NS. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Interventional Cardiology Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. If the cause cannot be determined, withdraw the device or system as a unit. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . 0 cm from the distal tip. 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. 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. 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. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE.