Figure 3. 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. Possible complications include, but are not limited to, the following: The Indigo Separator 4 is not intended for use as a guidewire. 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. Penumbra Aspiration Pump: Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . 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. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). Indigo System | Computer-Aided Mechanical Aspiration. 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. Final angiogram after stent placement showing resolution of underlying disease. 0, and 37. The results may vary depending on a variety of patient specific attributes. This content is not intended to offer professional medical advice. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Figure 1. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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. 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Precautions The device is intended for single use only. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. 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 . No modification of this equipment is allowed. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Indigo System CAT RX tracking through the distal posterior tibial artery. Copyright 2023 Penumbra, Inc. All rights reserved. Do not resterilize or reuse. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The product-specific content of this website is intended for use by healthcare professionals only. Suhail Dohad, MD, FACC She was in a rehab facility prior to this new event recovering from her CVA. We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. 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. Figure 2. Do not use kinked or damaged devices. . Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . 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. Warnings/Precautions The canister is intended for single use only. 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. Do not use kinked or damaged devices. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. Created with Sketch. Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. SVG occlusions can be challenging to resolve using traditional treatment modalities. 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. Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious . The atraumatic, low-profile design of CAT RX allowed for ease of deliverability through the freshly placed stent into the PDA when the patient was in critical condition. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). 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. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Relying on a different mechanism of action, power aspiration with CAT RX and Penumbra ENGINE was able to extract the thrombus intact; thus restoring flow through the graft. 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. 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. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. 510 (k) Number. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. INDIGO System LIGHTNING Aspiration Tubing Intended Use The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Throughout each case, Lightning provides procedural feedback via audiovisual cues. 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. 2023 Bryn Mawr Communications II, LLC. 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. The CAT family of catheters is the foundation of Penumbra's Indigo System. 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 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. window.dataLayer = window.dataLayer || []; The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. The patient remained on cangrelor with no need for tirofiban. Placing guidewire too distal in the pulmonary vasculature or excessive manipulation of aspiration/guiding catheter in the smaller, peripheral, and segmental pulmonary artery branches can result in vessel perforation. 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. 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. 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 Swan-Ganz catheter was exchanged over a long V18 wire. 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. 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. Contraindications Not for use in the coronaries or the neurovasculature. Disclosures: None. The Penumbra CAT RX catheter was used in a total of 34 patients, with 71% STEMI, 23% NSTEMI, 3% UA, and 3% new onset heart failure. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. After IVUS, the stent was dilated to 3.75 mm. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. Alameda, CA 94502. Contraindications 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. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. PENUMBRA ENGINE Indication for Use The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Next Article Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. 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. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Possible complications include, but are not limited to, the following: BJC Cardiology Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. Copyright 2022 Penumbra, Inc. All rights reserved. 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. 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: Flow through left circumflex artery post-CAT RX. Kingsport, Tennessee The CAT8 is indicated for removal of emboli and thrombi from the peripheral . Copyright 2023 Penumbra, Inc. All rights reserved. Do not use in an oxygen rich environment. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. Figure 1. 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 the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Return all damaged devices and packaging to the manufacturer/ distributor. It will reduce service life of the Penumbra ENGINE. Chris Metzger, MD Do not resterilize or reuse. 5, 21. Engineered with neuro-tracking technology, CAT RX is designed to navigate tortuous anatomy and track to distal coronary vasculature while maintaining sustained mechanical aspiration with the Penumbra ENGINE. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. The INDIGO Aspiration Tubing: gtag('js', new Date()); Jolly SS, Cairns JA, Lavi S, et al. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Device Name. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. 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. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Ultrasound-guided access was obtained through the right femoral vein. 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The Indigo Aspiration System is contraindicated in: Figure 2. 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. Circulation. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. System Chair, Clinical Research Potential Adverse Events Use only water-based solvents for cleaning. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Smidt Heart institute The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Figure 2. Do not reuse. Vedantham S, Goldhaber SZ, Julian JA, et al. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. 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. Do not re-infuse blood or fluid from the canister back into the patient. The cat8 was kinked approximately 69. Use prior to the Use By date. 1. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Latest System Designed for Single Session Arterial Thrombus Removal News Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . 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. 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. 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. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. INDIGO Aspiration Catheters and Separators: Worcester, Massachusetts The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 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. 3. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth.