cat8 penumbra catheter

Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. PENUMBRA ENGINE Indication for Use Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). The CAT familyof catheters is the foundation of Penumbras Indigo System. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Jolly SS, Cairns JA, Yusuf S, et al. Warnings function gtag(){dataLayer.push(arguments);} 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 . The INDIGO Aspiration System is intended to serve as a conduit to assist in thrombus removal and restoration of blood flow in the peripheral vasculature and for the treatment of pulmonary embolism. Copyright 2022 Penumbra, Inc. All rights reserved. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. PDF May 15, 2018 - Food And Drug Administration Jawairia Sahar K. Mirza, MBBS 2017;377:2240-2252. All Rights Reserved Privacy Policy, 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; Suhail Dohad, MD, FACC. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Learn more about Lightning. 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 patient remained on cangrelor with no need for tirofiban. 3. 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. Thrombectomy & Embolization | Vascular Medical Devices - Penumbra Inc Worcester, Massachusetts 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. 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 Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Figure 2. 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. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. function gtag(){dataLayer.push(arguments);} 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). Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. This website is intended for US audience only. Contraindications There are no known contraindications. Do not use open or damaged packages. 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. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. The device is intended for single use only. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. 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. To prevent fire or shock hazard, use a replacement power cord of equal rating. Penumbra, CAT8TORQ85, Penumbra CAT8 Indigo Aspiration Catheter, Torq When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. The cat8 was kinked approximately 69. 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. SVG occlusions can be challenging to resolve using traditional treatment modalities. 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. After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Units in stock: 1. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. Precautions The device is intended or single use only. window.dataLayer = window.dataLayer || []; 5 and 94. The CAT family of catheters is the foundation of Penumbra's Indigo system. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. PENUMBRA: CAT6 - WestCMR 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. 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. 2. Vascular Thrombectomy. Next Article Use only water-based solvents for cleaning. Do not use in an oxygen rich environment. Latest System Designed for Single Session Arterial Thrombus Removal News kolskiwellness@gmail.com This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. 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. There was partial improvement of flow, but total occlusion remained. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. The pain became more intense and constant, so he presented to the ED. St. Joseph Hospital Two passes of CAT RX with the Penumbra ENGINE resulted in TIMI 3 flow restoration and retrieval of the distal emboli from the PDA (Figure 3). The CAT family of catheters is the foundation of Penumbra's Indigo System. Penumbra's not relying on software alone. Do not resterilize or reuse. No modification of this equipment is allowed. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. 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). Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Penumbra Aspiration Pump: Potential Adverse Events The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Copyright 2022 Penumbra, Inc. All rights reserved. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. After one pass with CAT RX, the initial occlusion was removed. The procedure was completed with the same catheter. Distal emboli causing PDA occlusion after manual aspiration. 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. Director of Cardiac & Peripheral Cath Lab Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. This website is intended for US audience only. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Director, Structural Heart Only use replacement fuse with correct rating (see Table 1 for fuse rating). 2023 Bryn Mawr Communications II, LLC. Use prior to the Use By date. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. 2018;72:1589-1596. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. Smidt Heart institute 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 built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. To prevent fire or shock hazard, use a replacement power cord of equal rating. 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. Alameda, CA 94502. Circulation. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Throughout each case, Lightning provides procedural feedback via audio visual cues. Initial angiogram showing high thrombus burden in the RCA. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. Penumbra Aspiration Pump: The CAT family of catheters is the foundation of Penumbra's Indigo System. The means of mains disconnect is to remove the power cord. 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. 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. CAT8XTORQ115KIT-NS. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. This ability of lobar thrombectomy likely allowed EXTRACT-PE to be the first endovascular IDE, pulmonary embolism trial that has reported statistically significant reduction in on-table systolic pulmonary artery pressures. 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. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 Penumbra Indigo System | Vascular Thrombectomy 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. These pages are not intended for patients or for members of the general public. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . 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. Penumbra Cat 8 - IndiaMART With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Do not use open or damaged packages. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. Los Angeles, California CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. Do not resterilize or reuse. Copyright 2023 Penumbra, Inc. All rights reserved. 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. Distal posterior tibial artery emboli occlusion. o The Penumbra Indigo System Separator is intended for use with our Indigo System's family of catheters to enable the removal of a wide range of thrombus. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. Do not reuse. She was in a rehab facility prior to this new event recovering from her CVA. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. 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). Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. Figure 1. Rethinking Thrombus Removal With the Indigo System: Introducing 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. Results of EXTRACT-PE Trial presented at Vascular InterVentional Advances (VIVA) Annual Meeting Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced that the EXTRACT-PE trial successfully met the primary endpoints, demonstrating the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with .

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