cat8 penumbra catheter
Penumbra's not relying on software alone. These pages are not intended for patients or for members of the general public. Indication For Use In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). The CAT familyof catheters is the foundation of Penumbras Indigo System. . The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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. 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). Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. There were no cases of 30-day cardiovascular death or post procedural stroke. 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. Orange, California Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. PENUMBRA ENGINE Indication for Use Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. 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. This website is intended for US audience only. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. INDIGO Aspiration Catheters and Separators: These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. 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. 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. 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. gtag('js', new Date()); Contraindications Brian Kolski, MD No modification of this equipment is allowed. 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. 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 canister is intended for single use only. Contraindications There are no contraindications. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Director of Cardiac Catheterization Lab, PERT & Structural Heart 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. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. 3. Potential Adverse Events 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. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Indication For Use Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. The procedure was completed with the same catheter. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. 0, and 37. 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. 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). Do not block bottom or back air vents. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. 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. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 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. 2018;29:92-100. The Indigo Separator 4 is not intended for use as a guidewire. Sista A. Indigo aspiration system for acute pulmonary embolism. Indigo System Intended Use Unit may overheat and shut off or fail to restart if run for extended periods without airflow. window.dataLayer = window.dataLayer || []; If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. The pain became more intense and constant, so he presented to the ED. Contraindications There are no known contraindications. 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. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). 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 . Otherwise, this could result in degradation of the performance of this equipment. 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. This content is not intended to offer professional medical advice. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. Penumbra Aspiration Pump: J Vasc Interv Radiol. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. 8: Add BMK6F95M-NE . Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Director of Cardiac & Peripheral Cath Lab Use prior to the Use By date. 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. Prior to use, please consult device labeling and instructions for use. S. Jay Mathews, MD, MS, FACC A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. St. Joseph Hospital Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . 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. With the maximized inner diameter of 0.082 and a 7 French outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. CAT RX has allowed us to rethink how we approach these occluded SVGs. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. Use prior to the Use By date. This case illustrates the vast improvement in aspiration technology with an easy-to-deliver, trackable catheter that maintains sustained aspiration for the duration of the procedure. The low-profile catheter and Penumbra ENGINE are easy to set up and use. Precautions Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . chronic clot, atherosclerotic plaque) Worcester, Massachusetts Do not resterilize or reuse. 2023 Bryn Mawr Communications II, LLC. N Engl J Med. 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 sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Copyright 2022 Penumbra, Inc. All rights reserved. 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. 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 is potentially more effective than diminished syringe-based aspiration. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. 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. Potential Adverse Events Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. 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. 0, 23. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. Do not resterilize or reuse. Preprocedure TIMI 0 flow was seen in 76.3% of patients; TIMI 3 flow immediately post-CAT RX was demonstrated in 93.2% of patients. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Return all damaged devices and packaging to the manufacturer/distributor. 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. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. Figure 2. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. Use prior to the Use By date. UMassMemorial University Campus Smidt Heart institute Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). 510 (k) Number. She was in a rehab facility prior to this new event recovering from her CVA. If the cause cannot be determined, withdraw the device or system as a unit. gus.theodos@bjc.org; @gtheodosmd 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. There are no contraindications. 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 treatment of arterial and venous thrombus is challenging. Waqas R. Qureshi, MD, MS 2: Add Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. 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. Control angiography immediately after thrombectomy demonstrated restored patency . 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. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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. Initial angiogram showing high thrombus burden in the left circumflex artery. Maintain a constant infusion of appropriate flush solution. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. Copyright 2022 Penumbra, Inc. All rights reserved. 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. Vascular Thrombectomy. Potential Adverse Events Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. Contraindications Flow through left circumflex artery post-CAT RX. Tareq Kass-Hout. Related Items. gtag('js', new Date()); Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. The CAT family of catheters is the foundation of Penumbra's Indigo System. This is potentially more effective than diminished syringe-based aspiration. Penumbra ENGINE Intended Use The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . 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. Distal OD. 1. CAT RX is an essential tool in our percutaneous coronary armamentarium. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. The Indigo Aspiration System is contraindicated in: suhail.dohad@cshs.org Final angiogram after stent placement showing resolution of underlying disease. 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 . 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. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Warnings/Precautions The canister is intended for single use only. Created with Sketch. Do not use kinked or damaged devices. Device Name. 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 Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Penumbra ENGINE Indication For Use 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 . window.dataLayer = window.dataLayer || []; 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. SVG occlusions can be challenging to resolve using traditional treatment modalities. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Enter your email address and we will contact you. Potential Adverse Events 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. Created with Sketch. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. These types of burns heal withing 5 or 6 days without permanent scarring. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Distal OD, Sterile, Single-Use, Disposable, For CAT8 Penumbra Devices, Indigo Aspiration Catheters, Removal of Fresh, Soft Emboli and Thrombi from Vessels of Peripheral Arterial and Venous Systems Return all damaged devices and packaging to the manufacturer/distributor. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. Do not resterilize or reuse. 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 . 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. The procedure can be performed quickly,1 which is important for symptomatic patients. 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. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. Ballad CVA Heart & Vascular Institute 5 and 94. Do not resterilize or reuse. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. UPC: Current Stock: This item is out of stock. This website is intended for US audience only. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . INDIGO Aspiration Tubing: Disclosures: Consultant to Penumbra, Inc. An 83-year-old woman transferred from an outside hospital presented with acute shortness of breath, was hypotensive, and was intubated. The product-specific content of this website is intended for use by healthcare professionals only. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Do not use kinked or damaged devices. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. Contraindications 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. 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 Figure 2. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. 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 .
cat8 penumbra catheter