Further evaluation of the returned device revealed kinks in the catheter shaft. Precautions Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. If the cause cannot be determined, withdraw the device or system as a unit. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Brandenton, Florida These pages are not intended for patients or for members of the general public. Not for use in the coronaries or the neurovasculature. The complaint indicated that the cat8 was kinked during the procedure. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Enter your email address and we will contact you. Contraindications Not for use in the coronaries or the neurovasculature. (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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Indication For Use Control angiography immediately after thrombectomy demonstrated restored patency . J Vasc Interv Radiol. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Equipment is not safe for MR use. 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. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. INDIGO Aspiration Catheters and Separators: Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. 1.10 Summary of Non-Clinical Data As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a Do not use open or damaged packages. Giri J, Sista AK, Weinberg J, et al. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. IN-DATE. 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 Copyright 2022 Penumbra, Inc. All rights reserved. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. The treatment of arterial and venous thrombus is challenging. To prevent fire or shock hazard, use a replacement power cord of equal rating. INDIGO Aspiration Tubing: The device is intended for single use only. Figure 2. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 Indication for Use 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. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. Maintain a constant infusion of appropriate flush solution. 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. The CAT family of catheters is the foundation of Penumbra's Indigo System. The CAT family of catheters is the foundation of Penumbra's Indigo system. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. 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. Figure 2. Los Angeles, California Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. 2. 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). 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 the PENUMBRA ENGINE. The Indigo Separator 4 is not intended for use as a guidewire. These pages are not intended for patients or for members of the general public. Potential Adverse Events The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Learn more about Lightning. Do not resterilize or reuse. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Mechanical Thrombectomy. 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. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. Applicant. Latest System Designed for Single Session Arterial Thrombus Removal News CAT7 and CAT12 are the next generation of the Indigo System catheters. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. 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. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Penumbra Aspiration Pump: Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. Contraindications This website is intended for US audience only. 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. Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the PENUMBRA ENGINE as they can interfere with and result in degradation of the performance of the equipment. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Mathews SJ, Brown C, Kolski B, et al. Figure 1. SVG occlusions can be challenging to resolve using traditional treatment modalities. Aspiration Tubing Intended Use Throughout each case, Lightning provides procedural feedback via audiovisual cues. INDIGO Aspiration System Intended Use 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. Otherwise, this could result in degradation of the performance of this equipment. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. Potential Adverse Events Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Contraindications Precautions The device is intended for single use only. 3. Units in stock: 1. Indigo System CAT RX tracking through the distal posterior tibial artery. Do not block bottom air vents. gtag('js', new Date()); Figure 2. 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. 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 Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Maintain a constant infusion of appropriate flush solution. Use only water-based solvents for cleaning. function gtag(){dataLayer.push(arguments);} 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 SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. The Penumbra P logos, 3D, 3D Revascularization Device, ACE, BENCHMARK, CAT, Indigo, LANTERN, MAX, Neuron, Neuron MAX, Penumbra ENGINE, Penumbra JET, Penumbra System, Penumbra SMART COIL, POD, Ruby, Separator, Velocity, and WAVE are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. Sista A. Indigo aspiration system for acute pulmonary embolism. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 0 cm from the distal tip. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. UPC: Current Stock: . Figure 3. 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 System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. Use prior to the Use By date. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . This content is not intended to offer professional medical advice. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Do not block bottom or back air vents. 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. Smidt Heart institute Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. UMassMemorial University Campus Penumbra, Inc. One Penumbra Place. right-arrow If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. After IVUS, the stent was dilated to 3.75 mm. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. Possible complications include, but are not limited to, the following: 2019;140:e774-e801. 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. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Do not reuse. The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. 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. 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. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. 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. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Jolly SS, Cairns JA, Yusuf S, et al. Do not use kinked or damaged devices. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. Disclosures: Consultant to Penumbra, Inc. A 59-year-old man with a history of hypertension and tobacco use presented with an inferior-posterior acute myocardial infarction (MI). This website is intended for US audience only. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . The INDIGO SEPARATOR is not intended for use as a guidewire. 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. Do not resterilize or reuse. window.dataLayer = window.dataLayer || []; Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. The means of mains disconnect is to remove the power cord. Prior to use, please consult device labeling and instructions for use. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. 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. Saxon RR, Benenati JF, Teigen C, et al. Disclosures: None. Jolly SS, Cairns JA, Lavi S, et al. INDIGO Aspiration System Intended Use Flow through left circumflex artery post-CAT RX. These types of burns heal withing 5 or 6 days without permanent scarring. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. Interventional Cardiology In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. The product-specific content of this website is intended for use by healthcare professionals only. QUICK VIEW. Copyright 2023 Penumbra, Inc. All rights reserved. Figure 1. . 3. The complaint has been evaluated. Medical Director, Aortic Disease and Ischemic Limb Disease Do not use open or damaged packages. The cat8 was kinked approximately 69. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 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. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. left-arrow Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. Chris Metzger, MD Do not use in oxygen rich environment. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). 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 patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Prior to use, please consult device labeling and instructions for use. 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. No modification of this equipment is allowed. 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. function gtag(){dataLayer.push(arguments);} Do not use open or damaged packages. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. 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. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Do not use in oxygen rich environment. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Mechanical thrombectomy was performed. 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. 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. suhail.dohad@cshs.org Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. 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. 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. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Copyright 2023 Penumbra, Inc. All rights reserved. 1. She had acute tubular necrosis with minimal urine output at the time of transfer. The means of mains disconnect is to remove the power cord. 2018;29:92-100. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. St. Joseph Hospital Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . There was partial improvement of flow, but total occlusion remained. PENUMBRA ENGINE Indication for Use 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. Manual aspiration suffers from diminished aspiration force as fluid fills in the syringe, potentially resulting in systemic embolization during catheter removal, as shown in the TOTAL trial published in 2015 (Figure 1).1 Subgroup analysis of patients with high thrombus burden was explored that highlighted the potential for improved outcomes.