Latest System Designed for Single Session Arterial Thrombus Removal News Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. waqas.qureshi@umassmemorial.org 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. Warnings/Precautions PENUMBRA: SEP8 - Westcmr.com Contraindications Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. 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. 3. S. Jay Mathews, MD, MS, FACC 0 cm from the hub. 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. 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. J Vasc Interv Radiol. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. System Chair, Clinical Research Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. 1. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. Do not re-infuse blood or fluid from the canister back into the patient. 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. She had acute tubular necrosis with minimal urine output at the time of transfer. Penumbra CAT6, Indigo system Aspiration Catheter 6F, 135cm - MedicalEcart CAT RX is an essential tool in our percutaneous coronary armamentarium. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. Rethinking Thrombus Removal With the Indigo System: Introducing Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Figure 3. Alameda, CA 94502. The device is intended for single use only. 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. function gtag(){dataLayer.push(arguments);} 1. The pulmonary capillary wedge pressure is 10 mmHg. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. 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. Return all damaged devices and packaging to the manufacturer/distributor. Use only waterbased solvents for cleaning. 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. Vedantham S, Goldhaber SZ, Julian JA, et al. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. 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 . Contraindications Not for use in the coronaries or the neurovasculature. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. 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. Next Article Otherwise, this could result in degradation of the performance of this equipment. 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. Precautions The device is intended for single use only. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. UPC: Current Stock: . It will reduce service life of the Penumbra ENGINE. Do not use kinked or damaged devices. Do not block bottom or back air vents. Figure 2. Figure 1. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm Contraindications 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. Penumbra aspiration assistance | Medical Billing and Coding Forum - AAPC 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 Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. Penumbra Augments Vascular Franchise with Latest Indigo System Launch Return all damaged devices and packaging to the manufacturer/distributor. PENUMBRA: CAT6 - WestCMR Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 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 open or damaged packages. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm . Return all damaged devices and packaging to the manufacturer/distributor. Worcester, Massachusetts 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. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. Missouri Baptist Medical Center Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. 2023 Bryn Mawr Communications II, LLC. Equipment is not safe for MR use. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Possible complications include, but are not limited to, the following: 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. Gus Theodos, MD, FACC, FSCAI Waqas R. Qureshi, MD, MS 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. 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. Penumbra Announces U.S. Commercial Availability of INDIGO System Contraindications There are no contraindications. Penumbra's high-performance aspiration catheters. 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. Photo: Courtesy of Business Wire. Suhail Dohad, MD, FACC Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). Only use replacement fuse with correct rating (see Table 1 for fuse rating). 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, trackable, atraumatic and well suited for the peripheral anatomy. Indigo System | Computer-Aided Mechanical Aspiration. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Kingsport, Tennessee Final angiogram after mechanical thrombectomy with CAT8 and SEP8. window.dataLayer = window.dataLayer || []; Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. The patient underwent six shocks and was intubated while CAT RX was delivered through the freshly placed 3.5- X 38-mm DES to the PDA. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Warnings When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. 3. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Do not use open or damaged packages. After one pass with mechanical thrombectomy using CAT RX, the thrombus was removed and flow was restored to the pedal arch via the plantar posterior tibial artery (Figure 2 and Figure 3). 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. 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. skin is red but turns white when pressed Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. 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. 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 Aspiration Catheters to the Penumbra Aspiration Pump. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. After one pass with CAT RX, the initial occlusion was removed. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. Copyright 2023 Penumbra, Inc. All rights reserved. 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.
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