She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. 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 Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. gtag('js', new Date()); The means of mains disconnect is to remove the power cord. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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.
Catheters - Aspiration Catheters - Page 1 - Medical Materials The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 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. 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. St. Joseph Hospital
A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3).
Penumbra Recalls JET 7 Catheters with Xtra Flex -Risk of Mortality Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. 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. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. Equipment is not safe for MR use. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Enter your email address and we will contact you. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Interventional Cardiology
Figure 1. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Cedars Sinai Medical Center
Contraindications There are no known contraindications. Saxon RR, Benenati JF, Teigen C, et al. Indication For Use Penumbra ENGINE Intended Use The CAT8 is indicated for removal of emboli and thrombi from the peripheral . 5 and 94. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. Initial angiogram of the right pulmonary artery showing pulmonary embolism. The cat8 was kinked approximately 69. Do not use open or damaged packages. Do not use open or damaged packages. J Vasc Interv Radiol. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: Maintain a constant infusion of appropriate flush solution. The canister is intended for single use only. window.dataLayer = window.dataLayer || []; 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. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. LIGHTNING Aspiration Tubing Indication for Use When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. This press release features multimedia.
MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. CAT7 and CAT12 are the next generation of the Indigo System catheters. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. 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 . 510 (k) Number.
Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight 2018;29:92-100. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. Copyright 2022 Penumbra, Inc. All rights reserved. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. 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 . There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. Do not use kinked or damaged devices. Do not use kinked or damaged devices. Possible complications include, but are not limited to, the following: Potential Adverse Events The procedure was completed with the same catheter. Utility of a power aspiration-based extraction technique as an initial and secondary approach in the treatment of peripheral arterial thromboembolism: results of the multicenter PRISM Trial. She was in a rehab facility prior to this new event recovering from her CVA. 2. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). Penumbras IndigoAspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 3. System Chair, Clinical Research
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. Catheters & Separators. Worcester, Massachusetts
Copyright 2023 Penumbra, Inc. All rights reserved. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli.
Penumbra enrols first patient in CHEETAH Study of Indigo CAT RX device Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Do not use open or damaged packages. Potential Adverse Events Return all damaged devices and packaging to the manufacturer/distributor. 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; 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
MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION Initial angiogram showing high thrombus burden in the left circumflex artery. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. Director of Cardiac & Peripheral Cath Lab
Learn more about Lightning. Lightning comes packaged with the Indigo CAT7 or CAT12. An Interview With Binita Shah, MD, MS, FACC, FSCAI, By Mansi Oberoi, MD; M. Chadi Alraies, MD; and Poonam Velagapudi, MD, MS, Left Main Disease and Bifurcation Revascularization in Female Patients, By Tara L. Jones, MD, PharmD, and Valeria Paradies, MD, By Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, Applying Team-Based Care Delivery to Interventional Cardiology: Learnings from the 2022 MedAxiom CV APP Survey, Understanding Sex Differences in Acute and Chronic Coronary Syndromes, By F. Aaysha Cader, MBBS, MD, MRCP(UK), MSc(Oxon); Rudaynah Amein Alali, MBBS, Internal Medicine Board, Interventional Cardiology Fellowship, RCPI; and Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, SuperSaturated Oxygen Therapy: Cases and Cocktails Event Winning Presentations, With Charishma Nallapati, MD; Amer N. Kadri, MD; James Richard Spears, MD; Zaid Al-Jebaje, MD; Babar Basir, DO; and Khaldoon Alaswad, MD, FACC, FSCAI. 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 . 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 . kolskiwellness@gmail.com