cat8 penumbra catheter

Figure 2. Pela bainha, foi introduzido o dispositivo de aspirao Penumbra Indigo System CAT8 XTORQ (Penumbra Inc., Alameda, Califrnia, Estados Unidos) em trombo segmentar, lobar ou arterial pulmonar principal, sendo realizada aspirao contnua (Figuras 2 e 3). Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Penumbras IndigoAspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Initial angiography revealed an occlusion of the distal RCA. 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. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. Do not resterilize or reuse. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. gus.theodos@bjc.org; @gtheodosmd Copyright 2022 Penumbra, Inc. All rights reserved. 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. left-arrow 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. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. 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 Indigo Separator 4 is not intended for use as a guidewire. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. Contraindications Only use replacement fuse with correct rating (see Table 1 for fuse rating). 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. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . 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. 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. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. The patient received a 3.5- X 38-mm everolimus-eluting stent (Synergy drug-eluting stent [DES], Boston Scientific Corporation) with postdilation optimized by intravascular ultrasound (IVUS) and was then sent to the step-down unit. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . Equipment is not safe for MR use. Do not use open or damaged packages. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. This is potentially more effective than diminished syringe-based aspiration. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. 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. Do not resterilize or reuse. 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 utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum to our catheters to remove thrombus in vessels of various sizes. Photo: Courtesy of Business Wire. Copyright 2023 Penumbra, Inc. All rights reserved. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Related Items. 2018;29:92-100. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). 0 cm from the distal tip. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. The CAT family of catheters is the foundation of Penumbra's Indigo system. 5, 21. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Interventional Cardiology Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Resterilization and/or reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location. 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. 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. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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. Otherwise, this could result in degradation of the performance of this equipment. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . Not for use in the coronaries or the neurovasculature. No modification of this equipment is allowed. 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. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. 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 ENGINE Indication For Use 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. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. With a maximised inner diameter of 0.08 (2.1 mm) and a 7 French (2.3 mm) outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. S. Jay Mathews, MD, MS, FACC The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. 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. Penumbra ENGINE Intended Use Do not use in an oxygen rich environment. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 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; . Use only waterbased solvents for cleaning. The Penumbra ENGINE addresses the limitations of traditional treatment options by providing sustained mechanical power aspiration for the duration of the procedure to help maximize efficiency of thrombus removal. Saint Louis, Missouri These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. 1. Contraindications There are no known contraindications. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. Director, Structural Heart Circulation. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Do not use kinked or damaged devices. Lightning comes packaged with the Indigo CAT7 or CAT12. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. The complaint has been evaluated. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Orange, California Do not resterilize or reuse. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. Precautions The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . 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 . A Penumbra CAT8 catheter was placed into the right upper lobe, right middle lobe, and right lower lobe, and aspiration with a separator was performed. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. 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 Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. 2018;72:1589-1596. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. 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. Figure 1. The CAT family of catheters is the foundation of Penumbras Indigo System. Return all damaged devices and packaging to the manufacturer/distributor. INDIGO Aspiration System Intended Use Using the usual telescoping technique of the sheath, the CAT8 and SEP8 were used in tandem to aspirate the thrombus using sustained aspiration with Penumbra ENGINE. 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. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Do not resterilize or reuse. The procedure was completed with the same catheter. 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. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. The device is intended for single use only. After IVUS, the stent was dilated to 3.75 mm. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. Return all damaged devices and packaging to the manufacturer/distributor. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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). UPC: Current Stock: . 8: Add BMK6F95M-NE . Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. 0 cm from the hub. INDIGO Aspiration Catheters and Separators: Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. gtag('js', new Date()); Brandenton, Florida The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. 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. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. 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. 2019;140:e774-e801. 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. Do not use kinked or damaged devices. Device Name. 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. $399.00 EACH. 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). 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 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. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. To prevent fire or shock hazard, use a replacement power cord of equal rating. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies.

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