Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 2019;140:e774-e801. No modification of this equipment is allowed. 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. The penumbra cat8 indigo system (cat8) was kinked approximately 4. 510 (k) Number.
Penumbra's Newest Generation of Indigo Aspiration System Receives FDA 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.
PENUMBRA: CAT6 - WestCMR The means of mains disconnect is to remove the power cord. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. The procedure was completed with the same catheter. The low-profile catheter and Penumbra ENGINE are easy to set up and use. Do not block bottom or back air vents. Applicant. Pela bainha, foi introduzido o dispositivo de aspirao Penumbra Indigo System CAT8 XTORQ (Penumbra Inc., Alameda, Califrnia, Estados Unidos) em trombo segmentar, lobar ou arterial pulmonar principal, sendo realizada aspirao contnua (Figuras 2 e 3). System Chair, Clinical Research
The INDIGO Aspiration Tubing: 0, 24. CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral . Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Mathews SJ, Brown C, Kolski B, et al. Otherwise, this could result in degradation of the performance of this equipment. INDIGO Aspiration System Intended Use S. Jay Mathews, MD, MS, FACC
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). If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 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. We expect the results to further refine and improve our technique for mechanical aspiration and fine-tune the use of CAT RX for patients with high thrombus burden. 0 cm from the hub. 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.
Lightning Flash: The Most Powerful and Advanced Mechanical 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. 3. Conclusions: evaluation of the cat8 revealed that the device was fractured. 0 cm from the distal tip. Missouri Baptist Medical Center
The atraumatic tip and small catheter French size of the CAT8 device allows for easy tracking and maneuvering through the vasculature and selective debulking of thrombus from lobar branches of the pulmonary arterial tree. 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. Aspiration Tubing Intended Use Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 0, 26. 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. 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. Control angiography immediately after thrombectomy demonstrated restored patency . 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. Suhail Dohad, MD, FACC
INDIGO Aspiration System Intended Use UMassMemorial University Campus
Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. 2017;377:2240-2252. Director of Cardiac & Peripheral Cath Lab
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. 8: Add BMK6F95M-NE . . Cedars Sinai Medical Center
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. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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: Available in a selection of sizes, the CAT family can provide access to distal peripheral . 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. 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 . The removal of fibrous, adherent or calcified material (e.g.
Mechanical Aspiration Thrombectomy Using the Penumbra CAT RX - PubMed Saint Louis, Missouri
To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. Only use replacement fuse with correct rating (see Table 1 for fuse rating). 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.
Penumbra Announces U.S. Commercial Availability of INDIGO System Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 1. The Penumbra ENGINE addresses the limitations of traditional treatment options by providing sustained mechanical power aspiration for the duration of the procedure to help maximize efficiency of thrombus removal. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4:
CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm window.dataLayer = window.dataLayer || []; Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon 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. 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. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Otherwise, this could result in degradation of the performance of this equipment. Precautions The device is intended or single use only. 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.
skin is red but turns white when pressed An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. 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. Use prior to the Use By date. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Bradenton Cardiology Center/Manatee Memorial Hospital
Prior to use, please consult device labeling and instructions for use. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 (Penumbra, Inc.) are indicated for the removal of fresh soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The low-profile catheter and Penumbra . Disclosures: None. Figure 2. The cerebral vasculature Gus Theodos, MD, FACC, FSCAI
The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. The Indigo System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. Indigo System CAT RX tracking through the distal posterior tibial artery. 0, and 37. chronic clot, atherosclerotic plaque) A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. 3. Director of Cardiac Catheterization Lab, PERT & Structural Heart
Initial angiogram of the right pulmonary artery showing pulmonary embolism. 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. Penumbra ENGINE Indication For Use The canister is intended for single use only. BJC Cardiology
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 . UPC: Current Stock: This item is out of stock.
US physicians publish "first reported use" of Indigo aspiration system o The Penumbra Indigo System Separator is intended for use with our Indigo System's family of catheters to enable the removal of a wide range of thrombus. The cat8 was kinked approximately 69. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Figure 1. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. J Vasc Interv Radiol. function gtag(){dataLayer.push(arguments);} Vascular Thrombectomy. Throughout each case, Lightning provides procedural feedback via audio visual cues. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). The Indigo System utilises the Penumbra ENGINE aspiration source capable of delivering nearly pure, continuous vacuum (-29 inHg or 98.2 kPa) to our catheters, enabling thrombus removal in vessels of various sizes. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Penumbra Aspiration Pump: Worcester, Massachusetts
kolskiwellness@gmail.com
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). Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. If repositioning of the Indigo CAT RX Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard guidewire techniques. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Do not resterilize or reuse. Jolly SS, Cairns JA, Yusuf S, et al. Do not block bottom air vents. left-arrow
Indigo System - Vascupedia Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 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. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. Return all damaged devices and packaging to the manufacturer/ distributor. 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. Warnings/Precautions For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 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). Circulation. Not for use in the coronaries or the neurovasculature. 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 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. N Engl J Med.
Penumbra, CAT8XTORQ115, Penumbra CAT8 Indigo Aspiration Catheter, XTorq Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. 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. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. In 2014, Penumbra broke into the peripheral thrombectomy space with the release of the first Indigo System catheters, the 5-F CAT5 catheter and the 3-F CAT3 catheter (Penumbra, Inc.). Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures.
Penumbra Indigo Aspiration System IDE Trial for Acute Pulmonary Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. 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. Warnings 1.10 Summary of Non-Clinical Data As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a Device Name. Do not use in an oxygen rich environment. Maintain a constant infusion of appropriate flush solution. Do not use kinked or damaged devices. These pages are not intended for patients or for members of the general public. Do not use open or damaged packages. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. 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.
Rethinking Thrombus Removal With the Indigo System: Introducing Jolly SS, Cairns JA, Lavi S, et al. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 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. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. This website is intended for US audience only. gus.theodos@bjc.org; @gtheodosmd
Indigo Aspiration System Intended Use The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum (-29 inHg or 98.2 kPa) to our catheters, enabling thrombus removal in vessels of various sizes. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. The CAT familyof catheters is the foundation of Penumbras Indigo System. 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. No modification of this equipment is allowed. 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. 1. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Figure 3. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy.
Indigo System Catheters & Separators | Penumbra Inc Do not use kinked or damaged devices. If the cause cannot be determined, withdraw the device or system as a unit. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. In our practice, we have been able to more accurately define percutaneous transluminal coronary angioplasty and stent length as a result of this increased visualization. Copyright 2022 Penumbra, Inc. All rights reserved. Indigo System | Computer-Aided Mechanical Aspiration. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Use prior to the Use By date. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. Return all damaged devices and packaging to the manufacturer/distributor. The product-specific content of this website is intended for use by healthcare professionals only. Final angiogram with complete TIMI 3 flow after the use of CAT RX. To prevent fire or shock hazard, use a replacement power cord of equal rating. 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 CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series.
Penumbra aspiration assistance | Medical Billing and Coding Forum - AAPC The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. 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. 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. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. 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. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. The patient remained on cangrelor with no need for tirofiban. Use prior to the Use By date. 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 . Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. Use only water-based solvents for cleaning. The CAT family of catheters is the foundation of Penumbras Indigo System. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis.
Penumbra Announces U.S. Commercial Availability of INDIGO System If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
How Penumbra's smart-sucking algorithms and catheters speed up clot The Indigo Aspiration System is contraindicated in:
To prevent fire or shock hazard, use a replacement power cord of equal rating.
MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION Orange, California
Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. She had acute tubular necrosis with minimal urine output at the time of transfer.