Innovation in Coronary Mechanical Thrombectomy: Indigo System CAT RX CAT RX has allowed us to rethink how we approach these occluded SVGs. Copyright 2022 Penumbra, Inc. All rights reserved. 510 (k) Number. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Do not use in an oxygen rich environment. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. 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. Worcester, Massachusetts
Only use replacement fuse with correct rating (see Table 1 for fuse rating). 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. Use only water-based solvents for cleaning.
SciELO - Brasil - Suporte mecnico extracorpreo e trombectomia por Do not block bottom air vents. Penumbra's not relying on software alone. Lightning comes packaged with the Indigo CAT7 or CAT12. Precautions 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. These pages are not intended for patients or for members of the general public. 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. 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 . INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. 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. chronic clot, atherosclerotic plaque) The cerebral vasculature Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques.
Penumbra Announces U.S. Commercial Availability of INDIGO System Neuro | Penumbra, Inc. | Mechanical Thrombectomy & Embolization This content is not intended to offer professional medical advice. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 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 median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. 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, 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: A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. St. Joseph Hospital
Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight Maintain a constant infusion of appropriate flush solution. 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 Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. 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. 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. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. 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. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. 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). Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. Potential Adverse Events Penumbras IndigoAspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Kingsport, Tennessee
At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. Warnings/Precautions LIGHTNING Aspiration Tubing Indication for Use The system uses Penumbra's RED reperfusion catheters. Suhail Dohad, MD, FACC
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. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. Initial angiogram showing high thrombus burden in the RCA.
How Penumbra's smart-sucking algorithms and catheters speed up clot Missouri Baptist Medical Center
The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Giri J, Sista AK, Weinberg J, et al. The treatment of arterial and venous thrombus is challenging. 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. 0, and 37. Throughout each case, Lightning provides procedural feedback via audiovisual cues. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. It will reduce service life of the Penumbra ENGINE. Alameda, CA 94502. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Return all damaged devices and packaging to the manufacturer/distributor. Medical Director, Aortic Disease and Ischemic Limb Disease
The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. Two passes of CAT RX with the Penumbra ENGINE resulted in TIMI 3 flow restoration and retrieval of the distal emboli from the PDA (Figure 3). Vascular Thrombectomy. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. 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. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. The pain became more intense and constant, so he presented to the ED. 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.