cat8 penumbra catheter

This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. 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. 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. There were no cases of 30-day cardiovascular death or post procedural stroke. To prevent fire or shock hazard, use a replacement power cord of equal rating. Precautions Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8 DXE: Back to Search Results: Model Number CAT8XTORQ115KIT-S: Device Problems Break (1069); Physical Resistance/Sticking (4012) Patient Problem No Clinical Signs, Symptoms or Conditions (4582) Event Date 05/19/2021: Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. 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. 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. . The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Penumbra Indigo Aspiration System IDE Trial for Acute Pulmonary The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 2015;372:1389-1398. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. SciELO - Brasil - Suporte mecnico extracorpreo e trombectomia por Alameda, CA 94502. Otherwise, this could result in degradation of the performance of this equipment. Distal emboli causing PDA occlusion after manual aspiration. Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight Do not use kinked or damaged devices. Do not re-infuse blood or fluid from the canister back into the patient. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Ultrasound-guided access was obtained through the right femoral vein. 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. PDF May 15, 2018 - Food And Drug Administration Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 1. Warnings The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. BJC Cardiology Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. function gtag(){dataLayer.push(arguments);} The Indigo System met its efficacy and safety endpoints by reducing right-to-left ventricle (RV/LV) ratio at 48 hours by 27.3% (mean ratio reduction, 0.43; 95% confidence interval, 0.380.47; P < .0001) and had a low major adverse event of 1.7% (2/119). Relying on a different mechanism of action, power aspiration with CAT RX and Penumbra ENGINE was able to extract the thrombus intact; thus restoring flow through the graft. Figure 2. The cat8 was kinked approximately 69. CAT RX has allowed us to rethink how we approach these occluded SVGs. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. 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. right-arrow 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. Do not use open or damaged packages. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. Contraindications 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 Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . 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. Do not use kinked or damaged devices. Disclosures: Consultant to Penumbra, Inc. A 92-year-old man with a history of coronary artery disease (treated previously with coronary artery bypass graft) and severe aortic stenosis (treated previously with transcatheter aortic valve replacement) presented to the ED with chest pain. Saint Louis, Missouri The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). A 65-cm 8-F Destination sheath (Terumo Interventional Systems) was advanced into the right pulmonary artery, first over a telescoping balloon tip catheter and stiff angle Glidewire (Terumo Interventional Systems). Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Flow through left circumflex artery post-CAT RX. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Use prior to the Use By date. J Vasc Interv Radiol. The CAT family of catheters is the foundation of Penumbra's Indigo system. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. The patient remained on cangrelor with no need for tirofiban. The results may vary depending on a variety of patient specific attributes. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. Do not use kinked or damaged devices. Chris Metzger, MD To prevent fire or shock hazard, use a replacement power cord of equal rating. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. kolskiwellness@gmail.com When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Do not resterilize or reuse. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. 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 cerebral vasculature Indigo System | Penumbra Inc Jawairia Sahar K. Mirza, MBBS Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. This is potentially more effective than diminished syringe-based aspiration. Prior to use, please consult device labeling and instructions for use. Director of Cardiac & Peripheral Cath Lab Contraindications Figure 2. If the cause cannot be determined, withdraw the device or system as a unit. Precautions The device is intended or single use only. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). 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 . 5, 21. Created with Sketch. 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. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. The pulmonary capillary wedge pressure is 10 mmHg. If the cause cannot be determined, withdraw the device or system as a unit. Additional Details. Mechanical Aspiration Thrombectomy Using the Penumbra CAT RX - PubMed 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. Initial angiogram of the right pulmonary artery showing pulmonary embolism. skin is red but turns white when pressed Copyright 2023 Penumbra, Inc. All rights reserved. INDIGO Aspiration System Intended Use Penumbra Aspiration Pump: Figure 1. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous 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; Mechanical Thrombectomy | Medical Billing and Coding Forum - AAPC The Indigo System aspiration catheters are available in a range of lengths and diameters that, when connected to the Penumbra ENGINE pump, can atraumatically remove the thrombus present in various peripheral vascular beds. Indication For Use Equipment is not safe for MR use. Indication For Use 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. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use 0 cm from the distal tip. She had acute tubular necrosis with minimal urine output at the time of transfer. Potential Adverse Events Distal OD. 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. 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.

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