Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. 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. INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. Return all damaged devices and packaging to the manufacturer/distributor. Do not use open or damaged packages. . Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 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. window.dataLayer = window.dataLayer || []; The Indigo Aspiration System is contraindicated in: Copyright 2023 Penumbra, Inc. All rights reserved. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. The device is intended for single use only. 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. UPC: Current Stock: This item is out of stock. 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. Latest System Designed for Single Session Arterial Thrombus Removal News This website is intended for US audience only. Prior to use, please consult device labeling and instructions for use. This site is protected by reCAPTCHA and the Google, Mechanical clot engagement with proprietary Separator technology, Tip directionality for circumferential aspiration, The Indigo System is an integrated system for use only with other components of the Indigo System including the CAT family of catheters, Separators, Dynamic Aspiration Tubing, Lightning, Penumbra ENGINE, and Penumbra ENGINE Canister, Lightning Intelligent Aspiration comes packaged with CAT7, CAT8 or CAT12, Live feedback during the procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister. INDIGO Aspiration System Intended Use 2. 22. Mechanical thrombectomy was performed. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. This website is intended for US audience only. Do not resterilize or reuse. Initial angiography revealed an occlusion of the distal RCA. Indigo System Intended Use 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. 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. SVG occlusions can be challenging to resolve using traditional treatment modalities. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. Ballad CVA Heart & Vascular Institute
Penumbra ENGINE Intended Use Categories. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. 8: Add BMK6F95M-NE . Do not use kinked or damaged devices. It will reduce the service life of the PENUMBRA ENGINE. The means of mains disconnect is to remove the power cord. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. Use prior to the Use By date. Only use replacement fuse with correct rating (see Table 1 for fuse rating). 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. Possible complications include, but are not limited to, the following: acute vessel occlusion; air embolism; allergic reaction and anaphylaxis from contrast media or device material; anemia; arrhythmia; arteriovenous fistula; cardiac injury, cardiac perforation, cardiac tamponade; cardio-respiratory arrest; compartment syndrome; death; emboli; emergent surgery; foreign body embolization; hematoma or hemorrhage at access site; hemoptysis; hemorrhage; hypotension/hypertension; infarction leading to organ damage; infection; ischemia; myocardial infarction; neurological deficits including stroke; pneumothorax; pseudoaneurysm; renal impairment or acute renal failure from contrast media; residual thrombus due to inability to completely remove thrombus or control blood flow; respiratory failure; valvular damage; vessel spasm, thrombosis, dissection (intimal disruption), or perforation. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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 results may vary depending on a variety of patient specific attributes. Penumbra, a US-based provider of advanced therapies, has enrolled the first patient into the CHEETAH clinical study, designed to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. The CAT family of catheters is the foundation of Penumbras Indigo System. 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. Smidt Heart institute
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; and Suhail Dohad, MD, FACC. Do not resterilize or reuse. The pain became more intense and constant, so he presented to the ED. 2017;377:2240-2252. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Indication For Use J Vasc Interv Radiol. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. 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. After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. 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. Warnings Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Contraindications Penumbra Aspiration Pump: Copyright 2023 Penumbra, Inc. All rights reserved. UMassMemorial University Campus
0 cm from the distal tip. Missouri Baptist Medical Center
2019;140:e774-e801. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. Tareq Kass-Hout. suhail.dohad@cshs.org
Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. INDIGO Aspiration Tubing: Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. The canister is intended for single use only. Mathews SJ, Brown C, Kolski B, et al. Figure 1. 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 built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Do not use kinked or damaged devices. The complaint indicated that the cat8 was kinked during the procedure. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. Return all damaged devices and packaging to the manufacturer/distributor. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Precautions Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. 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. The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. 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. CAT7 and CAT12 are the next generation of the Indigo System catheters. 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 .