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Do not use kinked or damaged devices. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Los Angeles, California The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Figure 2. 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. Precautions The device is intended for single use only. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Latest System Designed for Single Session Arterial Thrombus Removal News 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: Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Ultrasound-guided access was obtained through the right femoral vein. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System.The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. 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. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. The INDIGO Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems and certain central circulatory system conditions such as pulmonary emboli using continuous aspiration. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 5, 21. Enter your email address and we will contact you. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . 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. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. Do not use kinked or damaged devices. The Indigo System CAT RX was the preferred choice for mechanical aspiration thrombectomy to remove the distal emboli below the knee in the posterior tibial artery. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Copyright 2022 Penumbra, Inc. All rights reserved. The product-specific content of this website is intended for use by healthcare professionals only. The Swan-Ganz catheter was exchanged over a long V18 wire. Please email [email protected] or call us at 877-663-8686 and we will try to locate the product with our suppliers. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Do not use in an oxygen rich environment. If the cause cannot be determined, withdraw the device or system as a unit. Return all damaged devices and packaging to the manufacturer/distributor. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. Vedantham S, Goldhaber SZ, Julian JA, et al. 1. 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. The procedure was completed with the same catheter. 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. . For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 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 CAT family of catheters is the foundation of Penumbra's Indigo System. The device is intended for single use only. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. Return all damaged devices and packaging to the manufacturer/distributor. The Indigo System Catheter CAT8 was used across 22 sites in the United States in patients with submassive PE who did not receive thrombolytics (98.3%), with a . Control angiography immediately after thrombectomy demonstrated restored patency . PENUMBRA ENGINE Intended Use Mechanical power aspiration with the Indigo System CAT RX (Penumbra, Inc.), introduced in 2018, continues to gain in popularity as a solution for high thrombus burden in the coronaries. Do not resterilize or reuse. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Return all damaged devices and packaging to the manufacturer/distributor. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. Conclusions: evaluation of the cat8 revealed that the device was fractured. The complaint indicated that the cat8 was kinked during the procedure. 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. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Jolly SS, Cairns JA, Lavi S, et al. 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. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. 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. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Order Qty. UPC: Current Stock: This item is out of stock. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. 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. The means of mains disconnect is to remove the power cord. 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. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. Use prior to the Use By date. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. The INDIGO SEPARATOR is not intended for use as a guidewire. Do not use in an oxygen rich environment. Penumbra's high-performance aspiration catheters. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. 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. 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 resterilize or reuse. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. 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. 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). Use prior to the Use By date. Distal emboli causing PDA occlusion after manual aspiration. SVG occlusions can be challenging to resolve using traditional treatment modalities. 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. 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. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. gtag('js', new Date()); Contraindications There are no contraindications. If the cause cannot be determined, withdraw the device or system as a unit. The system uses Penumbra's RED reperfusion catheters. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Warnings/Precautions The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli.

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