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 . LIGHTNING Aspiration Tubing is a sterile aspiration tubing component of the INDIGO Aspiration System and 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. Do not re-infuse blood or fluid from the canister back into the patient. In a retrospective analysis of patients in our practice with fresh thrombus burden, we have observed TIMI 3 restored when using CAT RX frontline.1 This is another positive patient outcome with the use of CAT RX in a case of high thrombus burden. Giri J, Sista AK, Weinberg J, et al. Maintain a constant infusion of appropriate flush solution. If the cause cannot be determined, withdraw the device or system as a unit. Utility of a power aspiration-based extraction technique as an initial and secondary approach in the treatment of peripheral arterial thromboembolism: results of the multicenter PRISM Trial. The complaint indicated that the cat8 was kinked during the procedure. Waqas R. Qureshi, MD, MS
Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. CAT RX has allowed us to rethink how we approach these occluded SVGs. Do not resterilize or reuse. Control angiography immediately after thrombectomy demonstrated restored patency . Maintain a constant infusion of appropriate flush solution. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. 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 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. This is potentially more effective than diminished syringe-based aspiration. Penumbra's high-performance aspiration catheters.
Rethinking Thrombus Removal With the Indigo System: Introducing 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. The Indigo Separator 4 is not intended for use as a guidewire. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. To prevent fire or shock hazard, use a replacement power cord of equal rating. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . The INDIGO Aspiration Tubing: The low-profile catheter and Penumbra . INDIGO Aspiration Catheters and Separators: Figure 3. Indication For Use Figure 2. 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.
Penumbra, CAT8TORQ85, Penumbra CAT8 Indigo Aspiration Catheter, Torq Catheters & Separators. 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. Chris Metzger, MD
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. There were no cases of 30-day cardiovascular death or post procedural stroke. 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). 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. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. 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. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. Return all damaged devices and packaging to the manufacturer/distributor. IN-DATE. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Penumbras IndigoAspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. Latest System Designed for Single Session Arterial Thrombus Removal News There was partial improvement of flow, but total occlusion remained. 2. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Preprocedure TIMI 0 flow was seen in 76.3% of patients; TIMI 3 flow immediately post-CAT RX was demonstrated in 93.2% of patients. Contraindications There are no known contraindications. It will reduce the service life of the PENUMBRA ENGINE. 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. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Do not use kinked or damaged devices. 2: Add The Indigo Aspiration System is contraindicated in: 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.
Mechanical Thrombectomy | Medical Billing and Coding Forum - AAPC Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. 1. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Cedars Sinai Medical Center
A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. If the cause cannot be determined, withdraw the device or system as a unit. 0, 23. 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 Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Indigo System CAT RX tracking through the distal posterior tibial artery. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. She had acute tubular necrosis with minimal urine output at the time of transfer. 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. Additional Details. Do not use open or damaged packages. The INDIGO SEPARATOR is not intended for use as a guidewire. The means of mains disconnect is to remove the power cord. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. The Indigo Aspiration System is comprised of several devices: The Indigo System is used as a first-line approach or rescue therapy for arterial and venous thrombotic events. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Figure 1. PENUMBRA ENGINE Intended Use
Indigo System - Vascupedia Ultrasound-guided access was obtained through the right femoral vein. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 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. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. 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. The means of mains disconnect is to remove the power cord. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. 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: 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. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . Return all damaged devices and packaging to the manufacturer/distributor. 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. 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. 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. Use only water-based solvents for cleaning. This content is not intended to offer professional medical advice. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Contraindications Penumbra Aspiration Pump: Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. 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.
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 . gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. kolskiwellness@gmail.com
Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. INDIGO Aspiration System Intended Use 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. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. 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. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. 2023 Bryn Mawr Communications II, LLC. Related Items. This website is intended for US audience only. Precautions The device is intended for single use only. 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. 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. Contraindications Do not use kinked or damaged devices. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. 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. waqas.qureshi@umassmemorial.org
How Penumbra's smart-sucking algorithms and catheters speed up clot gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}.
Figure 2. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Figure 1. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. Figure 1. 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.