Rethinking Thrombus Removal With the Indigo System: Introducing INDIGO System LIGHTNING Aspiration Tubing Intended Use This website is intended for US audience only. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. 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. It will reduce service life of the Penumbra ENGINE. 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. Jawairia Sahar K. Mirza, MBBS
It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Further evaluation of the returned device revealed kinks in the catheter shaft. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. Potential Adverse Events 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. Use only waterbased solvents for cleaning. Precautions The device is intended or single use only.
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. . Categories. There are no contraindications. 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. Catheters & Separators. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch.
Indigo System Catheters & Separators | Penumbra Inc The cerebral vasculature chronic clot, atherosclerotic plaque)
US physicians publish "first reported use" of Indigo aspiration system These data are encouraging and have led to the next stage in data collection through the CHEETAH studya 400-patient, prospective, observational study evaluating the initial safety and performance of the Indigo Aspiration System CAT RX.
Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. The means of mains disconnect is to remove the power cord.
Mechanical Thrombectomy | Medical Billing and Coding Forum - AAPC Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. 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. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. Penumbra, Inc. One Penumbra Place. Device Name. Final angiographic result of SVG. Learn more about Lightning. Copyright 2023 Penumbra, Inc. All rights reserved. Gus Theodos, MD, FACC, FSCAI
Kingsport, Tennessee
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. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Do not resterilize or reuse. 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. Photo: Courtesy of Business Wire. Do not use in oxygen rich environment. Lightning comes packaged with the Indigo CAT7 or CAT12. Created with Sketch. gtag('js', new Date()); CAT RX is an essential tool in our percutaneous coronary armamentarium. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). The complaint has been evaluated. Do not use kinked or damaged devices.
Indigo System | Penumbra Inc Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Jolly SS, Cairns JA, Lavi S, et al. Do not re-infuse blood or fluid from the canister back into the patient. Precautions The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Figure 2. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. The low-profile catheter and Penumbra ENGINE are easy to set up and use. 0 cm from the distal tip. Available in a selection of sizes, the CAT family can enable access to distal peripheral vessels of the upper and lower extremities, including below the knee. Copyright 2022 Penumbra, Inc. All rights reserved. 0, and 37. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. The CAT family of catheters is the foundation of Penumbra's Indigo system. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. Copyright 2023 Penumbra, Inc. All rights reserved. Final angiogram after stent placement showing resolution of underlying disease. The CAT family of catheters is the foundation of Penumbra's Indigo System. Figure 3. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy.
The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. 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. 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. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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. 3D, 3D Revascularization Device, ACE, Artemis, BENCHMARK, CAT, Indigo, LANTERN, Lightning, MAX, Neuron, Neuron MAX, Penumbra Coil 400, Penumbra ENGINE, Penumbra P logos, Penumbra System, Penumbra SMART COIL, POD, PX SLIM, Ruby, Select, Separator, Velocity, and WAVE are all registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. Mathews SJ, Brown C, Kolski B, et al. 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. Distal posterior tibial artery emboli occlusion. After one pass with CAT RX, the initial occlusion was removed. Latest System Designed for Single Session Arterial Thrombus Removal News
Innovation in Coronary Mechanical Thrombectomy: Indigo System CAT RX K180412. INDIGO Aspiration Catheters and Separators: 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. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. Worcester, Massachusetts
Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm.
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 .
The Indigo System and CAT8 - Endovascular Today left-arrow When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Her heart rate was 110 beats per minute, elevated troponin levels at 4.5 ng/mL, and elevated brain natriuretic peptide at 1,164 pg/mL. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. window.dataLayer = window.dataLayer || []; The procedure can be performed quickly,1 which is important for symptomatic patients.
Penumbra Cat 8 - IndiaMART A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended.
Thrombectomy & Embolization | Vascular Medical Devices - Penumbra Inc Cedars Sinai Medical Center
2023 Bryn Mawr Communications II, LLC. 0 cm from the hub. 510 (k) Number. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Do not reuse. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. 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. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Giri J, Sista AK, Weinberg J, et al. Control angiography immediately after thrombectomy demonstrated restored patency . In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon Use prior to the Use By date. Enter your email address and we will contact you. 2018;72:1589-1596. 5, 21. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. Ballad CVA Heart & Vascular Institute
To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). Return all damaged devices and packaging to the manufacturer/distributor. 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. 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. Director of Cardiac & Peripheral Cath Lab
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. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy.
Indigo System Catheters & Separators | Penumbra Inc 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. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. 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 removal of fibrous, adherent or calcified material (e.g. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12.
Penumbra, CAT8XTORQ115, Penumbra CAT8 Indigo Aspiration Catheter, XTorq Sista A. Indigo aspiration system for acute pulmonary embolism. Conclusions: evaluation of the cat8 revealed that the device was fractured. Mathews SJ, Brown C, Kolski B, et al. function gtag(){dataLayer.push(arguments);} Equipment is not safe for MR use. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal.
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. Use prior to the Use By date. Do not use open or damaged packages. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. Figure 2. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. TIMI 3 flow was achieved in 88% of cases. 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. The Indigo Aspiration System is contraindicated in: Do not use in an oxygen rich environment. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2).
How Penumbra's smart-sucking algorithms and catheters speed up clot Penumbra Indigo System | Vascular Thrombectomy Do not resterilize or reuse. This content is not intended to offer professional medical advice. If the cause cannot be determined, withdraw the device or system as a unit.
PENUMBRA: CAT3 - westcmr.com If the cause cannot be determined, withdraw the device or system as a unit. 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. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. This is potentially more effective than diminished syringe-based aspiration. Possible complications include, but are not limited to, the following: Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 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. We presented our initial experience at the American College of Cardiologys (ACC) 68th Annual Scientific Session, which showed promising results for mechanical power aspiration for thrombus removal during percutaneous intervention using CAT RX.3 This retrospective case series included 59 patients from four institutions around the United States. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. There was partial improvement of flow, but total occlusion remained. The newest indication for the Indigo System is the treatment of pulmonary embolism; this indication comes on the heels of the promising results of the EXTRACT-PE trial. 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. J Vasc Interv Radiol. 2018;29:92-100. The device is intended for single use only. 1. Do not use open or damaged packages. 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 cat8 was kinked approximately 69. Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Initial angiogram of the right pulmonary artery showing pulmonary embolism. Figure 3. Penumbra ENGINE Intended Use When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 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). 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.
Neuro | Penumbra, Inc. | Mechanical Thrombectomy & Embolization Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. 0, 23. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus.