Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The pulmonary capillary wedge pressure is 10 mmHg. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Initial angiogram of the right pulmonary artery showing pulmonary embolism. There were no cases of 30-day cardiovascular death or post procedural stroke. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus.
Penumbra Announces U.S. Commercial Availability of INDIGO 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. 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Randomized trial of primary PCI with or without routine manual thrombectomy. Do not re-infuse blood or fluid from the canister back into the patient. Director of Cardiac Catheterization Lab, PERT & Structural Heart
function gtag(){dataLayer.push(arguments);} Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump.
Indigo System - Vascupedia Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. CAT7 and CAT12 are the next generation of the Indigo System Catheters. The INDIGO Aspiration Tubing: The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 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. 22. Do not use open or damaged packages.
CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra, CAT8TORQ85, Penumbra CAT8 Indigo Aspiration Catheter, Torq Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Penumbra ENGINE. PENUMBRA ENGINE Intended Use Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. After one pass with CAT RX, the initial occlusion was removed. Penumbra Aspiration Pump: Waqas R. Qureshi, MD, MS
MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 Photo: Courtesy of Business Wire. 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. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). The Indigo System CAT RX was the preferred choice for mechanical aspiration thrombectomy to remove the distal emboli below the knee in the posterior tibial artery. 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. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. 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 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. Saint Louis, Missouri
2. Figure 2. 2018;29:92-100. After IVUS, the stent was dilated to 3.75 mm. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. The product-specific content of this website is intended for use by healthcare professionals 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. 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 . Jawairia Sahar K. Mirza, MBBS
5 and 94. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Ballad CVA Heart & Vascular Institute
0, 24. left-arrow Precautions The device is intended for single use only. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. 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. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Do not block bottom or back air vents. 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. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. suhail.dohad@cshs.org
. The low-profile catheter and Penumbra . Throughout each case, Lightning provides procedural feedback via audiovisual cues. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Indication For Use The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. 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. These pages are not intended for patients or for members of the general public. Figure 2. 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. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Use prior to the Use By date.
510(k) Premarket Notification - Food And Drug Administration MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Created with Sketch. 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 The CAT family of catheters is the foundation of Penumbra's Indigo system. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Not for use in the coronaries or the neurovasculature. 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 resterilize or reuse.
Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm UMassMemorial University Campus
Director, Structural Heart
Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. . 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. Disclosures: None. Copyright 2023 Penumbra, Inc. All rights reserved. Categories. Giri J, Sista AK, Weinberg J, et al.
Penumbra Announces U.S. Commercial Availability of INDIGO System 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. Copyright 2023 Penumbra, Inc. All rights reserved. Interventional Cardiology
A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Otherwise, this could result in degradation of the performance of this equipment.
How Penumbra's smart-sucking algorithms and catheters speed up clot 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 Figure 2. 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. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. This is potentially more effective than diminished syringe-based aspiration. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Chris Metzger, MD
Jolly SS, Cairns JA, Lavi S, et al. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Bradenton Cardiology Center/Manatee Memorial Hospital
Potential Adverse Events 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. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal.
Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F(x) 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. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. . Disclosures: None. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. Precautions 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. The canister is intended for single use only. right-arrow $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . 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. 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.
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