cat8 penumbra catheter cat8 penumbra catheter

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. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. 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. Mechanical thrombectomy was performed. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Final angiogram showing resolution of extensive thrombus burden. Ballad CVA Heart & Vascular Institute Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. 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. . gtag('js', new Date()); Return all damaged devices and packaging to the manufacturer/distributor. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Photo: Courtesy of Business Wire. Potential Adverse Events Only use replacement fuse with correct rating (see Table 1 for fuse rating). INDIGO Aspiration System Intended Use Next Article Flow through left circumflex artery post-CAT RX. Otherwise, this could result in degradation of the performance of this equipment. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Potential Adverse Events Precautions The device is intended or single use only. There were no cases of 30-day cardiovascular death or post procedural stroke. 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. Conclusions: evaluation of the cat8 revealed that the device was fractured. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. This content is not intended to offer professional medical advice. 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 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. Do not use in an oxygen rich environment. . 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Chris Metzger, MD Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. Do not use kinked or damaged devices. 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. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. No modification of this equipment is allowed. 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. 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. Penumbra Aspiration Pump: Figure 2. 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 . Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. Copyright 2022 Penumbra, Inc. All rights reserved. 0, 24. The atraumatic, low-profile design of CAT RX allowed for ease of deliverability through the freshly placed stent into the PDA when the patient was in critical condition. 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. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Otherwise, this could result in degradation of the performance of this equipment. These pages are not intended for patients or for members of the general public. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 2018;72:1589-1596. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. This website is intended for US audience only. 3. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Distal posterior tibial artery emboli occlusion. J Am Coll Cardiol. Saxon RR, Benenati JF, Teigen C, et al. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. 2018;29:92-100. 2. window.dataLayer = window.dataLayer || []; J Vasc Interv Radiol. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . 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. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Use prior to the Use By date. S. Jay Mathews, MD, MS, FACC 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 . Orange, California Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. After one pass with CAT RX, the initial occlusion was removed. 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. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. 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. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Catheters & Separators. Worcester, Massachusetts Brandenton, Florida Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. Jawairia Sahar K. Mirza, MBBS 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 patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). 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. Prior to use, please consult device labeling and instructions for use. Brian Kolski, MD 0, and 37. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. Potential Adverse Events 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. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. 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. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Figure 1. The CAT family of catheters is the foundation of Penumbras Indigo System. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. Aspiration or disruption of thrombus with traditional diminished syringe-based aspiration or other mechanical devices is difficult, often incomplete, and has been associated with high complication rates.1 Use of medical therapy, such as powerful anticoagulants and thrombolytics (ie, tissue plasminogen activator), may carry a high risk of bleeding.2 The Indigo System was designed to provide sustained aspiration with Penumbra ENGINE to effectively remove thrombus, while reducing the risk of bleeding complications.3 The Indigo System utilizes atraumatic catheters varying in diameters from 3.4 to 8 F and lengths ranging from 50 to 150 cm. 0 cm from the distal tip. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Indigo System Intended Use Director of Cardiac & Peripheral Cath Lab Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. 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. Initial angiogram of the right pulmonary artery showing pulmonary embolism. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. Smidt Heart institute 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 Mechanical power aspiration with the Indigo System CAT RX (Penumbra, Inc.), introduced in 2018, continues to gain in popularity as a solution for high thrombus burden in the coronaries. The Penumbra P logos, 3D, 3D Revascularization Device, ACE, BENCHMARK, CAT, Indigo, LANTERN, MAX, Neuron, Neuron MAX, Penumbra ENGINE, Penumbra JET, Penumbra System, Penumbra SMART COIL, POD, Ruby, Separator, Velocity, and WAVE are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Do not resterilize or reuse. She had acute tubular necrosis with minimal urine output at the time of transfer. Do not reuse. 2: Add Penumbra's not relying on software alone. The removal of fibrous, adherent or calcified material (e.g. Indigo System | Computer-Aided Mechanical Aspiration. waqas.qureshi@umassmemorial.org gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. 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. Throughout each case, Lightning provides procedural feedback via audiovisual cues. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. CAT7 and CAT12 are the next generation of the Indigo System Catheters. These pages are not intended for patients or for members of the general public. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. The low-profile catheter and Penumbra ENGINE are easy to set up and use. Precautions 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. CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral . function gtag(){dataLayer.push(arguments);} 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 extremities, including below the knee. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. 5, 19. Use prior to the Use By date. Indication For Use 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. 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Indication For Use Penumbra ENGINE Intended Use Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Indication For Use The product-specific content of this website is intended for use by healthcare professionals only. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Potential Adverse Events Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arrhythmia; arteriovenous fistula; cardiac injury; cardio-respiratory arrest; death; device malfunction; distal embolization; emboli; excessive blood loss; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; hemoptysis; respiratory failure; thromboembolic events. Penumbra ENGINE Intended Use Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Vascular Thrombectomy. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. CAT RX is an essential tool in our percutaneous coronary armamentarium. 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. This website is intended for US audience only. 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 Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. CAT8XTORQ115KIT-NS. Equipment is not safe for MR use. The results may vary depending on a variety of patient specific attributes. Penumbra Aspiration Pump: Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. Do not block bottom or back air vents. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Distal emboli causing PDA occlusion after manual aspiration. Randomized trial of primary PCI with or without routine manual thrombectomy. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. 0, 26. She was in a rehab facility prior to this new event recovering from her CVA. Created with Sketch. Relying on a different mechanism of action, power aspiration with CAT RX and Penumbra ENGINE was able to extract the thrombus intact; thus restoring flow through the graft. 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). The pain became more intense and constant, so he presented to the ED. The advantages of CAT RX with Penumbra ENGINE include the potential to remove the thrombus intact and reduce the potential of systemic embolization while also increasing the visualization of the underlying stenosis and distal vessel. The Indigo Aspiration System is contraindicated in: Final angiographic result of SVG. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. 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. The pulmonary capillary wedge pressure is 10 mmHg. 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. 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. 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 Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. 1. INDIGO Aspiration System Intended Use Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. 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. The cat8 was kinked approximately 69. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). 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. 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 deliverability and continuous aspiration power were essential to achieving restoration of flow supporting a positive patient outcome to help heal this case of CLI. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 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.