chronic clot, atherosclerotic plaque) CAT7 and CAT12 are the next generation of the Indigo System Catheters. 0, 23. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Otherwise, this could result in degradation of the performance of this equipment. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. Pinterest; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm Penumbra System) Model #: CAT8XTORQ115KIT OEM: Penumbra System Expiration Date: 2022 Size : 8Fr x 115cm . MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Los Angeles, California Do not use kinked or damaged devices. Categories. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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. Disclosures: None. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. Return all damaged devices and packaging to the manufacturer/distributor. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). 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. Latest System Designed for Single Session Arterial Thrombus Removal News Figure 1. 0 cm from the distal tip. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Warnings Do not use open or damaged packages. waqas.qureshi@umassmemorial.org Indigo System Catheters & Separators | Penumbra Inc Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . J Vasc Interv Radiol. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. The results may vary depending on a variety of patient specific attributes. 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 patient remained on cangrelor with no need for tirofiban. 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. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. The Indigo System and CAT8 - Endovascular Today A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Thrombectomy & Embolization | Vascular Medical Devices - Penumbra Inc A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. 2. Do not use kinked or damaged devices. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Final angiogram with complete TIMI 3 flow after the use of CAT RX. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Ultrasound-guided access was obtained through the right femoral vein. US physicians publish "first reported use" of Indigo aspiration system In our practice, we have been able to more accurately define percutaneous transluminal coronary angioplasty and stent length as a result of this increased visualization. Potential Adverse Events The Indigo Separator 4 is not intended for use as a guidewire. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. 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 underwent six shocks and was intubated while CAT RX was delivered through the freshly placed 3.5- X 38-mm DES to the PDA. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. K180412. Mechanical Power Aspiration With the Indigo - Endovascular Today Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Saint Louis, Missouri Penumbra ENGINE Indication For Use Gus Theodos, MD, FACC, FSCAI Precautions The device is intended for single use only. Only use replacement fuse with correct rating (see Table 1 for fuse rating). 0, 24. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 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. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. 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. Penumbra Announces U.S. Commercial Availability of INDIGO System 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. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. 0, and 37. 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 . The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Indigo Aspiration System Intended Use Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. 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. Contraindications Not for use in the coronaries or the neurovasculature. The means of mains disconnect is to remove the power cord. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Device Name. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Distal posterior tibial artery emboli occlusion. The pain became more intense and constant, so he presented to the ED. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. 3. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Kingsport, Tennessee Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. SVG occlusions can be challenging to resolve using traditional treatment modalities. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Penumbra's not relying on software alone. 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. 510 (k) Number. If the cause cannot be determined, withdraw the device or system as a unit. It will reduce service life of the Penumbra ENGINE. Prior to use, please consult device labeling and instructions for use. Final angiogram after stent placement showing resolution of underlying disease. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. INDIGO Aspiration Catheters and Separators: The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Do not use in oxygen rich environment. 22. 1. N Engl J Med. 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). window.dataLayer = window.dataLayer || []; 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. Lightning Flash: The Most Powerful and Advanced Mechanical Return all damaged devices and packaging to the manufacturer/distributor. Neuro | Penumbra, Inc. | Mechanical Thrombectomy & Embolization This website is intended for US audience only. Penumbra, CAT8TORQ85, Penumbra CAT8 Indigo Aspiration Catheter, Torq CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. Director of Cardiac & Peripheral Cath Lab 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. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. SciELO - Brasil - Suporte mecnico extracorpreo e trombectomia por 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 device is intended for single use only. Indigo System Catheters & Separators | Penumbra Inc The removal of fibrous, adherent or calcified material (e.g. Penumbra enrols first patient in CHEETAH Study of Indigo CAT RX device 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 System met its efficacy and safety endpoints by reducing right-to-left ventricle (RV/LV) ratio at 48 hours by 27.3% (mean ratio reduction, 0.43; 95% confidence interval, 0.380.47; P < .0001) and had a low major adverse event of 1.7% (2/119). 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). 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. IN-DATE. 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. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). This content is not intended to offer professional medical advice. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. The treatment of arterial and venous thrombus is challenging. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. Use only water-based solvents for cleaning. 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). 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 pulmonary capillary wedge pressure is 10 mmHg. 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. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION 1. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . Use prior to the Use By date. CAT RX has allowed us to rethink how we approach these occluded SVGs. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. 2018;72:1589-1596. Due to our experience in such cases, sustained aspiration with the Indigo System CAT RX with Penumbra ENGINE has quickly become our frontline device, challenging the traditional method of manual aspiration in patients with thrombi and emboli in the coronary arteries. Jolly SS, Cairns JA, Lavi S, et al. A, Penumbra Indigo System Continuous Aspiration - ResearchGate The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. The CAT family of catheters is the foundation of Penumbra's Indigo System. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Disclosures: Consultant to Penumbra, Inc. A 92-year-old man with a history of coronary artery disease (treated previously with coronary artery bypass graft) and severe aortic stenosis (treated previously with transcatheter aortic valve replacement) presented to the ED with chest pain. Potential Adverse Events CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing 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. Do not reuse. Do not use open or damaged packages. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . PENUMBRA: CAT3 - westcmr.com Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. The procedure was completed with the same catheter. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. 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 with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. CAT RX is an essential tool in our percutaneous coronary armamentarium. Launches Indigo System Lightning 12 in U.S. Appoints Corey L. Teigen, M.D., as Chief Scientific Officer and James F. Benenati, M.D., FSIR, as Chief Medical Officer Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced its next phase for vascular franchise growth with U.S. commercial availability of the Indigo System Lightning 12 and . The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Catheters - Aspiration Catheters - Page 1 - Medical Materials 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. 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 PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Copyright 2023 Penumbra, Inc. All rights reserved. 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. Potential Adverse Events These pages are not intended for patients or for members of the general public. INDIGO Aspiration Tubing: 510(k) Premarket Notification - Food And Drug Administration The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Aspiration or disruption of thrombus with traditional diminished syringe-based aspiration or other mechanical devices is difficult, often incomplete, and has been associated with high complication rates.1 Use of medical therapy, such as powerful anticoagulants and thrombolytics (ie, tissue plasminogen activator), may carry a high risk of bleeding.2 The Indigo System was designed to provide sustained aspiration with Penumbra ENGINE to effectively remove thrombus, while reducing the risk of bleeding complications.3 The Indigo System utilizes atraumatic catheters varying in diameters from 3.4 to 8 F and lengths ranging from 50 to 150 cm. Maintain a constant infusion of appropriate flush solution. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). . J Am Coll Cardiol. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Maintain a constant infusion of appropriate flush solution. . 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. No modification of this equipment is allowed. Figure 1. INDIGO Aspiration System Intended Use The system uses Penumbra's RED reperfusion catheters. 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. Sista A. Indigo aspiration system for acute pulmonary embolism. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Power aspiration with CAT RX has allowed us to successfully remove thrombus in patients presenting with acute coronary syndrome, establishing quick distal reperfusion and also visualization of the underlying stenosis. 8: Add BMK6F95M-NE . Potential Adverse Events The CAT family of catheters is the foundation of Penumbra's Indigo system. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. Penumbra Aspiration Pump: Penumbra, Inc. One Penumbra Place. Prior to use, please consult device labeling and instructions for use. This content is not intended to offer professional medical advice. gtag('js', new Date()); Potential Adverse Events CAT7 and CAT12 are the next generation of the Indigo System catheters. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Do not resterilize or reuse. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. 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. CAT8XTORQ115KIT-NS. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. 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; The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. . 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. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. 2019;140:e774-e801. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . Penumbra Augments Vascular Franchise with Latest Indigo System Launch 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. Vascular Thrombectomy. (CAT3, CAT RX, CAT5, CAT6, CAT8, and CATD) and patented Separator technology, which maintains continuous aspiration and helps limit clogging of the catheters tip during the procedure. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Precautions Copyright 2022 Penumbra, Inc. All rights reserved. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. After one pass with CAT RX, the initial occlusion was removed. 2017;377:2240-2252. Physicians in the USA have published details ofto their knowledgethe "first reported use" of the Indigo aspiration system (Penumbra) to treat cerebral venous sinus thrombosis (CVST) via endovascular thrombectomy.The treated patient underwent successful partial recanalisation of the superior sagittal sinus (SSS) and bilateral transverse sinuses (TS), and experienced .