Indigo System Catheters & Separators | Penumbra Inc CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 0, 23. 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. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. US physicians publish "first reported use" of Indigo aspiration system Categories. Do not use open or damaged packages. 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. Penumbra ENGINE Indication For Use Penumbra, CAT8XTORQ115, Penumbra CAT8 Indigo Aspiration Catheter, XTorq Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. The penumbra cat8 indigo system (cat8) was kinked approximately 4. 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. 22. Cedars Sinai Medical Center INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 Indication for Use 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. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Distal OD. 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 Computer-Aided Aspiration comes packaged with CAT7 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. 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. Throughout each case, Lightning provides procedural feedback via audiovisual cues. 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. Created with Sketch. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. 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. Units in stock: 1. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Kingsport, Tennessee Indigo System - Vascupedia Use prior to the Use By date. Alameda, CA 94502. Penumbra, Inc. One Penumbra Place. Director, Structural Heart Figure 2. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. CAT RX has allowed us to rethink how we approach these occluded SVGs. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Rethinking Thrombus Removal With the Indigo System: Introducing There are no contraindications. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Jolly SS, Cairns JA, Lavi S, et al. Do not use open or damaged packages. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. 8: Add BMK6F95M-NE . Do not block bottom or back air vents. Vedantham S, Goldhaber SZ, Julian JA, et al. 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. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. 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. Penumbra Indigo Aspiration System IDE Trial for Acute Pulmonary 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. The INDIGO Aspiration System is intended to serve as a conduit to assist in thrombus removal and restoration of blood flow in the peripheral vasculature and for the treatment of pulmonary embolism. The patient received a 3.5- X 38-mm everolimus-eluting stent (Synergy drug-eluting stent [DES], Boston Scientific Corporation) with postdilation optimized by intravascular ultrasound (IVUS) and was then sent to the step-down unit. Caution: 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. Penumbra Augments Vascular Franchise with Latest Indigo System Launch Warnings/Precautions A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Indication For Use This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. Using the usual telescoping technique of the sheath, the CAT8 and SEP8 were used in tandem to aspirate the thrombus using sustained aspiration with Penumbra ENGINE. Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. The device is intended for single use only. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Do not use in an oxygen rich environment. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 0 cm from the distal tip. 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. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. Initial angiogram of the right pulmonary artery showing pulmonary embolism. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Circulation. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . 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. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. Warnings/Precautions The canister is intended for single use only. The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum to our catheters to remove thrombus in vessels of various sizes. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. CAT8XTORQ115KIT-NS. Launches Indigo System Lightning 12 in U.S. Appoints Corey L. Teigen, M.D., as Chief Scientific Officer and James F. Benenati, M.D., FSIR, as Chief Medical Officer Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced its next phase for vascular franchise growth with U.S. commercial availability of the Indigo System Lightning 12 and . Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . 0 cm from the hub. PENUMBRA: SEP8 - Westcmr.com 0, and 37. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. 2. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. No modification of this equipment is allowed. 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. (CAT3, CAT RX, CAT5, CAT6, CAT8, and CATD) and patented Separator technology, which maintains continuous aspiration and helps limit clogging of the catheters tip during the procedure. The product-specific content of this website is intended for use by healthcare professionals only. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. Only use replacement fuse with correct rating (see Table 1 for fuse rating). left-arrow How Penumbra's smart-sucking algorithms and catheters speed up clot Disclosures: None. Penumbra Recalls JET 7 Catheters with Xtra Flex -Risk of Mortality Warnings 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. Mechanical Power Aspiration With the Indigo - Endovascular Today window.dataLayer = window.dataLayer || []; For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. The patient underwent six shocks and was intubated while CAT RX was delivered through the freshly placed 3.5- X 38-mm DES to the PDA. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Prior to use, please consult device labeling and instructions for use. Do not re-infuse blood or fluid from the canister back into the patient. The procedure was completed with the same catheter. 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. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION Figure 2. 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. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . Potential Adverse Events Initial angiogram showing high thrombus burden in the left circumflex artery. Initial angiography revealed an occlusion of the distal RCA. Return all damaged devices and packaging to the manufacturer/distributor. Disclosures: None. 1. 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. Manual aspiration using a Pronto V3 (Teleflex) catheter restored some flow, however, distal embolization to the posterior descending artery (PDA) immediately caused right ventricular cardiac arrest (Figure 2). 2018;29:92-100. 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. 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. Copyright 2022 Penumbra, Inc. All rights reserved. We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. 1. After IVUS, the stent was dilated to 3.75 mm. 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. Sista A. Indigo aspiration system for acute pulmonary embolism. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Possible complications include, but are not limited to, the following: CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. Enter your email address and we will contact you. gtag('js', new Date()); A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. Chris Metzger, MD She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. PDF May 15, 2018 - Food And Drug Administration Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. Final angiographic result of SVG. Do not use kinked or damaged devices. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy.