CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Mechanical Thrombectomy | Medical Billing and Coding Forum - AAPC Figure 2. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Do not use in oxygen rich environment. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. Jolly SS, Cairns JA, Yusuf S, et al. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. 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. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Penumbra Augments Vascular Franchise with Latest Indigo System Launch The device is intended for single use only. CAT RX is an essential tool in our percutaneous coronary armamentarium. 0 cm from the hub. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Prior to use, please consult device labeling and instructions for use. Indigo System | Computer-Aided Mechanical Aspiration. Penumbra Announces U.S. Commercial Availability of INDIGO System The device is intended for single use only. 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. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. The product-specific content of this website is intended for use by healthcare professionals only. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Conclusions: evaluation of the cat8 revealed that the device was fractured. Do not use in oxygen rich environment. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. This website is intended for US audience only. The penumbra cat8 indigo system (cat8) was kinked approximately 4. Throughout each case, Lightning provides procedural feedback via audio visual cues. 2: Add Randomized trial of primary PCI with or without routine manual thrombectomy. 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. 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. 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. Results of EXTRACT-PE Trial presented at Vascular InterVentional Advances (VIVA) Annual Meeting Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced that the EXTRACT-PE trial successfully met the primary endpoints, demonstrating the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with . 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. Potential Adverse Events Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight 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. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. QUICK VIEW. A, Penumbra Indigo System Continuous Aspiration - ResearchGate The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Mechanical power aspiration with a continuous vacuum source and large lumen aspiration catheter was first introduced in the neurovascular space when Penumbra revolutionized thrombus removal for acute ischemic stroke patients. Figure 2. The cat8 was kinked approximately 69. Do not reuse. 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. This content is not intended to offer professional medical advice. 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. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). There are no contraindications. 2015;372:1389-1398. These types of burns heal withing 5 or 6 days without permanent scarring. Initial angiogram showing high thrombus burden in the left circumflex artery. SVG occlusions can be challenging to resolve using traditional treatment modalities. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Lightning Flash: The Most Powerful and Advanced Mechanical Applicant. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. gtag('js', new Date()); INDIGO Aspiration Catheters and Separators: Figure 1. 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 . An Interview With Binita Shah, MD, MS, FACC, FSCAI, By Mansi Oberoi, MD; M. Chadi Alraies, MD; and Poonam Velagapudi, MD, MS, Left Main Disease and Bifurcation Revascularization in Female Patients, By Tara L. Jones, MD, PharmD, and Valeria Paradies, MD, By Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, Applying Team-Based Care Delivery to Interventional Cardiology: Learnings from the 2022 MedAxiom CV APP Survey, Understanding Sex Differences in Acute and Chronic Coronary Syndromes, By F. Aaysha Cader, MBBS, MD, MRCP(UK), MSc(Oxon); Rudaynah Amein Alali, MBBS, Internal Medicine Board, Interventional Cardiology Fellowship, RCPI; and Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, SuperSaturated Oxygen Therapy: Cases and Cocktails Event Winning Presentations, With Charishma Nallapati, MD; Amer N. Kadri, MD; James Richard Spears, MD; Zaid Al-Jebaje, MD; Babar Basir, DO; and Khaldoon Alaswad, MD, FACC, FSCAI. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . The CAT family of catheters is the foundation of Penumbra's Indigo system. 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). 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. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. This website is intended for US audience only. 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Indication For Use Use prior to the Use By date. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. Do not use kinked or damaged devices. 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 Aspiration Pump: 5, 19. . Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. She was in a rehab facility prior to this new event recovering from her CVA. Precautions The device is intended or single use only. 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. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. This content is not intended to offer professional medical advice. 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. 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 only water-based solvents for cleaning. gtag('js', new Date()); Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F(x) The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. Do not use open or damaged packages. Flow through left circumflex artery post-CAT RX. Penumbra System Products - Medical Materials The means of mains disconnect is to remove the power cord. To prevent fire or shock hazard, use a replacement power cord of equal rating. 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. Return all damaged devices and packaging to the manufacturer/distributor. The procedure can be performed quickly,1 which is important for symptomatic patients. 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. Do not use open or damaged packages. 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. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 2017;377:2240-2252. To prevent fire or shock hazard, use a replacement power cord of equal rating. Figure 2. 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 System | Penumbra Inc Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Contraindications There are no known contraindications. Contraindications Worcester, Massachusetts Do not resterilize or reuse. After IVUS, the stent was dilated to 3.75 mm. If the cause cannot be determined, withdraw the device or system as a unit. Maintain a constant infusion of appropriate flush solution. Return all damaged devices and packaging to the manufacturer/distributor. Indigo Aspiration System Intended Use Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Figure 3. Final angiogram with complete TIMI 3 flow after the use of CAT RX. The INDIGO Aspiration System 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. Penumbra enrols first patient in CHEETAH Study of Indigo CAT RX device She had acute tubular necrosis with minimal urine output at the time of transfer. The treatment of arterial and venous thrombus is challenging. 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. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. Warnings/Precautions Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Return all damaged devices and packaging to the manufacturer/distributor. Use prior to the Use By date. Thrombectomy & Embolization | Vascular Medical Devices - Penumbra Inc 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). Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. Copyright 2023 Penumbra, Inc. All rights reserved. Use only waterbased solvents for cleaning. Penumbra's CAT family of catheters is engineered to be robust, trackable, atraumatic, and well suited to the peripheral anatomy where clots can form in long segments. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. Catheters - Aspiration Catheters - Page 1 - Medical Materials 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. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. Penumbra, CAT8TORQ85, Penumbra CAT8 Indigo Aspiration Catheter, Torq This is potentially more effective than diminished syringe-based aspiration. Initial angiogram showing high thrombus burden in the RCA. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Rethinking Thrombus Removal With the Indigo System: Introducing Do not reuse. 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. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. US physicians publish "first reported use" of Indigo aspiration system 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. St. Joseph Hospital Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. Mathews SJ, Brown C, Kolski B, et al. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . 1. 2019;140:e774-e801. function gtag(){dataLayer.push(arguments);} 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 combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 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 system uses Penumbra's RED reperfusion catheters. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 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. function gtag(){dataLayer.push(arguments);} When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. The patient remained on cangrelor with no need for tirofiban. Do not use open or damaged packages. 510(k) Premarket Notification - Food And Drug Administration 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 . [email protected]; @gtheodosmd Unit may overheat and shut off or fail to restart if run for extended periods without airflow. gtag('js', new Date()); Do not use in an oxygen rich environment. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. CAT8XTORQ115KIT-NS. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). The CAT family of catheters is the foundation of Penumbra's Indigo system. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). Catheters & Separators. 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: The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Contraindications There are no contraindications. Use prior to the Use By date. Created with Sketch. Pela bainha, foi introduzido o dispositivo de aspirao Penumbra Indigo System CAT8 XTORQ (Penumbra Inc., Alameda, Califrnia, Estados Unidos) em trombo segmentar, lobar ou arterial pulmonar principal, sendo realizada aspirao contnua (Figuras 2 e 3). 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. These pages are not intended for patients or for members of the general public. 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. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Penumbra Cat 8 - IndiaMART 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. Do not use open or damaged packages. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. 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. Prior to use, please consult device labeling and instructions for use. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. UPC: Current Stock: This item is out of stock. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. INDIGO Aspiration System Intended Use Equipment is not safe for MR use. Director of Cardiac Catheterization Lab, PERT & Structural Heart 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. Precautions Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Figure 3. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. IN-DATE. 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 Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. PDF May 15, 2018 - Food And Drug Administration 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). In 2014, Penumbra broke into the peripheral thrombectomy space with the release of the first Indigo System catheters, the 5-F CAT5 catheter and the 3-F CAT3 catheter (Penumbra, Inc.).