A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Learn more about Lightning. 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/fibrillation; arteriovenous fistula; death; device malfunction; distal embolization; emergent surgery; false aneurysm formation; hematoma, hemorrhage, or blood loss at access site; hematoma, hemorrhage, or blood loss; hypotension; inability to completely remove thrombus or control blood flow; infection; ischemia; kidney damage from contrast media; myocardial infarction; neurological deficits including stroke; respiratory failure; thromboembolic events; vascular complications (including vessel spasm, thrombosis, intimal disruption, dissection, or perforation). The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 3. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. 8: Add BMK6F95M-NE . When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Precautions The device is intended for single use only. The device is intended for single use only. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Do not use in an oxygen rich environment. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Throughout each case, Lightning provides procedural feedback via audio visual cues. The procedure was completed with the same catheter. The penumbra cat8 indigo system (cat8) was kinked approximately 4. Do not use open or damaged packages. 2018;29:92-100. The product-specific content of this website is intended for use by healthcare professionals only. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. The atraumatic, low-profile design of CAT RX allowed for ease of deliverability through the freshly placed stent into the PDA when the patient was in critical condition. The product-specific content of this website is intended for use by healthcare professionals only. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The Indigo Separator 4 is not intended for use as a guidewire. System Chair, Clinical Research
Prior to use, please consult device labeling and instructions for use. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. 0, and 37. Tareq Kass-Hout. 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. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Do not use kinked or damaged devices. 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.
PENUMBRA: CAT6 - WestCMR 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.
Rethinking Thrombus Removal With the Indigo System: Introducing Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Kingsport, Tennessee
Brandenton, Florida
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. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial.
Penumbra CAT6, Indigo system Aspiration Catheter 6F, 135cm - MedicalEcart The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. CAT RX is an essential tool in our percutaneous coronary armamentarium. 0, 24. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. Possible complications include, but are not limited to, the following: Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Warnings The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Use prior to the Use By date. This is potentially more effective than diminished syringe-based aspiration. Mathews SJ, Brown C, Kolski B, et al. Final angiogram after stent placement showing resolution of underlying disease. The device is intended for single use only. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. She had acute tubular necrosis with minimal urine output at the time of transfer. The Penumbra Indigo System Separator is intended for use with our Indigo Systems CAT family of catheters to enable the removal of a wide range of thrombus. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. Do not re-infuse blood or fluid from the canister back into the patient. LIGHTNING Aspiration Tubing Indication for Use 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 petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. The means of mains disconnect is to remove the power cord. The low-profile catheter and Penumbra . Flow through left circumflex artery post-CAT RX. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Figure 2. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. Prior to use, please consult device labeling and instructions for use. INDIGO Aspiration Tubing: These pages are not intended for patients or for members of the general public. Maintain a constant infusion of appropriate flush solution. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 2. 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. This content is not intended to offer professional medical advice. 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. function gtag(){dataLayer.push(arguments);} 1. Figure 1. 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 . 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. Return all damaged devices and packaging to the manufacturer/distributor. Potential Adverse Events Unit may overheat and shut off or fail to restart if run for extended periods without airflow. Penumbra ENGINE Intended Use Figure 2. The Indigo System CAT RX with Penumbra ENGINE is an invaluable tool that is easy to set up and can provide rapid thrombectomy and immediate reperfusion. The complaint has been evaluated.
Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm The treatment of arterial and venous thrombus is challenging. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep.
Penumbra Announces U.S. Commercial Availability of INDIGO System At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. Next Article Mechanical Thrombectomy. J Am Coll Cardiol. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 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. Indigo System | Computer-Aided Mechanical Aspiration. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. The Penumbra Indigo System Separator is intended for use with our Indigo Systems CAT family of catheters to enable the removal of a wide range of thrombus. These pages are not intended for patients or for members of the general public.
PDF May 15, 2018 - Food And Drug Administration The system uses Penumbra's RED reperfusion catheters. 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
SciELO - Brasil - Suporte mecnico extracorpreo e trombectomia por 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. All Rights Reserved Privacy Policy, 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; Suhail Dohad, MD, FACC.
Indigo System - Vascupedia 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 . Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal.
CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm 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 CAT familyof catheters is the foundation of Penumbras Indigo System. Indigo Aspiration System Intended Use
Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . This website is intended for US audience only. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . Jolly SS, Cairns JA, Yusuf S, et al. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Photo: Courtesy of Business Wire. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation.
Innovation in Coronary Mechanical Thrombectomy: Indigo System CAT RX There was partial improvement of flow, but total occlusion remained. right-arrow Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 1.
Catheters - Aspiration Catheters - Page 1 - Medical Materials Penumbra's Indigo Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. 0 cm from the hub. If the cause cannot be determined, withdraw the device or system as a unit. UPC: Current Stock: This item is out of stock. Do not resterilize or reuse. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly.
Penumbra Cat 8 - IndiaMART 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. Penumbra's LANTERN Delivery Microcatheter integrates a highly trackable 2.6 F microcatheter with a high-flow lumen to facilitate confident delivery of Ruby Coil, POD, and Packing Coil even in tortuous anatomy. The catheters (CAT3, CAT RX*, CAT5, CAT6, CAT8, CATD) vary in diameters from 3.4 to 8 F and lengths of 50 to 150 cm to .
Indigo System Catheters & Separators | Penumbra Inc Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. 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 the PENUMBRA ENGINE. To prevent fire or shock hazard, use a replacement power cord of equal rating. Cedars Sinai Medical Center
Figure 3. Return all damaged devices and packaging to the manufacturer/distributor. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Potential Adverse Events
excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . Maintain a constant infusion of appropriate flush solution. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Director, Structural Heart
Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . Worcester, Massachusetts
CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration.
Penumbra Augments Vascular Franchise with Latest Indigo System Launch Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump.
US physicians publish "first reported use" of Indigo aspiration system Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2).
MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. 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. kolskiwellness@gmail.com
This case illustrates the vast improvement in aspiration technology with an easy-to-deliver, trackable catheter that maintains sustained aspiration for the duration of the procedure. Warnings/Precautions Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Penumbra Aspiration Pump: These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. The results may vary depending on a variety of patient specific attributes. 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. Disclosures: None. The INDIGO SEPARATOR is not intended for use as a guidewire. 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. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. 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 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. These pages are not intended for patients or for members of the general public. 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 . Penumbra ENGINE Indication For Use The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. 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. PENUMBRA ENGINE Intended Use The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. 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. 0 cm from the distal tip. Resterilization and/or reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location.
Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. The advantages of CAT RX with Penumbra ENGINE include the potential to remove the thrombus intact and reduce the potential of systemic embolization while also increasing the visualization of the underlying stenosis and distal vessel. Final angiographic result of SVG. Missouri Baptist Medical Center
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. Categories. 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. This press release features multimedia. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Sista A. Indigo aspiration system for acute pulmonary embolism. Do not block bottom air vents. 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:
Indigo System CAT RX | Penumbra Inc The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics.
A, Penumbra Indigo System Continuous Aspiration - ResearchGate The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. 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. Use prior to the Use By date. 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. 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. Return all damaged devices and packaging to the manufacturer/distributor. window.dataLayer = window.dataLayer || []; Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. CAT7 and CAT12 are the next generation of the Indigo System catheters. Conclusions: evaluation of the cat8 revealed that the device was fractured.
Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight