CAT RX has allowed us to rethink how we approach these occluded SVGs. waqas.qureshi@umassmemorial.org Copyright 2023 Penumbra, Inc. All rights reserved. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. Penumbra Announces U.S. Commercial Availability of INDIGO System 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. 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. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. The pulmonary capillary wedge pressure is 10 mmHg. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. 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). The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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 in the presence of a flammable anesthetic mixture with air or nitrous oxide. Copyright 2022 Penumbra, Inc. All rights reserved. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. 510 (k) Number. Sista A. Indigo aspiration system for acute pulmonary embolism. Final angiogram after stent placement showing resolution of underlying disease. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. 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. Created with Sketch. The complaint indicated that the cat8 was kinked during the procedure. TIMI 3 flow was achieved in 88% of cases. The patient remained on cangrelor with no need for tirofiban. 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. Throughout each case, Lightning provides procedural feedback via audiovisual cues. Penumbra, CAT8TORQ85, Penumbra CAT8 Indigo Aspiration Catheter, Torq Maintain a constant infusion of appropriate flush solution. PENUMBRA ENGINE Intended Use Order Qty. Use prior to the Use By date. Distal OD. Contraindications Penumbras IndigoAspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. window.dataLayer = window.dataLayer || []; indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. If the cause cannot be determined, withdraw the device or system as a unit. 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. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Use prior to the Use By date. Potential Adverse Events The low-profile catheter and Penumbra ENGINE are easy to set up and use. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. Learn more about Lightning. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. 5 and 94. These pages are not intended for patients or for members of the general public. Precautions . Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 2018;72:1589-1596. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Do not resterilize or reuse. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. 3. Penumbra Aspiration Pump: CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. CAT7 and CAT12 are the next generation of the Indigo System catheters. INDIGO Aspiration System Intended Use Return all damaged devices and packaging to the manufacturer/ distributor. This press release features multimedia. Do not use kinked or damaged devices. The CAT family of catheters is the foundation of Penumbras Indigo System. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . Created with Sketch. Waqas R. Qureshi, MD, MS UPC: Current Stock: . Figure 2. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. Warnings/Precautions The canister is intended for single use only. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. Jawairia Sahar K. Mirza, MBBS Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. Do not resterilize or reuse. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Figure 2. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. 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. 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. 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. The patient received a 3.5- X 38-mm everolimus-eluting stent (Synergy drug-eluting stent [DES], Boston Scientific Corporation) with postdilation optimized by intravascular ultrasound (IVUS) and was then sent to the step-down unit. Kingsport, Tennessee Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral . Penumbras IndigoAspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Figure 1. suhail.dohad@cshs.org Vascular Thrombectomy. Do not use open or damaged packages. J Am Coll Cardiol. Further evaluation of the returned device revealed kinks in the catheter shaft. Do not use kinked or damaged devices. This content is not intended to offer professional medical advice. She was in a rehab facility prior to this new event recovering from her CVA. The results may vary depending on a variety of patient specific attributes. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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. 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);} Gus Theodos, MD, FACC, FSCAI Contraindications There are no contraindications. Do not resterilize or reuse. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 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. kolskiwellness@gmail.com Do not use kinked or damaged devices. Indigo System CAT RX tracking through the distal posterior tibial artery. The Indigo System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. Use prior to the Use By date. Maintain a constant infusion of appropriate flush solution. The Indigo System utilises the Penumbra ENGINE aspiration 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. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. The product-specific content of this website is intended for use by healthcare professionals only. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. N Engl J Med. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. window.dataLayer = window.dataLayer || []; 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. 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 . LIGHTNING Aspiration Tubing Indication for Use Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. This site is protected by reCAPTCHA and the Google, 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 Intelligent Aspiration comes packaged with CAT7, CAT8 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. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. 8: Add BMK6F95M-NE . Conclusions: evaluation of the cat8 revealed that the device was fractured. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Disclosures: None. After IVUS, the stent was dilated to 3.75 mm. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. Do not re-infuse blood or fluid from the canister back into the patient. PENUMBRA: CAT6 - WestCMR Copyright 2023 Penumbra, Inc. All rights reserved. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. 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 Aspiration System is contraindicated in: chronic clot, atherosclerotic plaque) UPC: Current Stock: This item is out of stock. Do not use open or damaged packages. 0, 26. Aspiration Tubing Intended Use After one pass with CAT RX, the initial occlusion was removed. Otherwise, this could result in degradation of the performance of this equipment. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. St. Joseph Hospital Penumbra ENGINE Intended Use Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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 Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. Penumbra System Products - Medical Materials A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. With the maximized inner diameter of 0.082 and a 7 French outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. These data are encouraging and have led to the next stage in data collection through the CHEETAH studya 400-patient, prospective, observational study evaluating the initial safety and performance of the Indigo Aspiration System CAT RX. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. QUICK VIEW. 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 Penumbra CAT8 catheter was placed into the right upper lobe, right middle lobe, and right lower lobe, and aspiration with a separator was performed. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. BJC Cardiology The Swan-Ganz catheter was exchanged over a long V18 wire. Precautions The device is intended for single use only. Penumbra Cat 8 - IndiaMART Do not use in oxygen rich environment. Separator 8, 150 cm Length, 0.072 in. 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. Disclosures: Consultant to Penumbra, Inc. An 83-year-old woman transferred from an outside hospital presented with acute shortness of breath, was hypotensive, and was intubated. . 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. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. 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. Initial angiography revealed an occlusion of the distal RCA. Otherwise, this could result in degradation of the performance of this equipment. $399.00 EACH. A, Penumbra Indigo System Continuous Aspiration - ResearchGate Disclosures: None. Control angiography immediately after thrombectomy demonstrated restored patency . To prevent fire or shock hazard, use a replacement power cord of equal rating. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Return all damaged devices and packaging to the manufacturer/distributor. Prior to use, please consult device labeling and instructions for use. 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. Related Items. . Precautions IN-DATE. The CAT family of catheters is the foundation of Penumbra's Indigo system. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Learn more about Lightning. Thrombectomy & Embolization | Vascular Medical Devices - Penumbra Inc Penumbra Announces U.S. Commercial Availability of INDIGO System gtag('js', new Date()); It will reduce the service life of the PENUMBRA ENGINE. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. Indication For Use Rethinking Thrombus Removal With the Indigo System: Introducing The large aspiration lumen and highly trackable, low-profile design coupled with the power of the Penumbra ENGINE resulted in the successful removal of the emboli in one pass. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. The system uses Penumbra's RED reperfusion catheters. Director of Cardiac Catheterization Lab, PERT & Structural Heart The Indigo System and CAT8 - Endovascular Today Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. Smidt Heart institute 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 Indigo Aspiration System IDE Trial for Acute Pulmonary 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. The procedure can be performed quickly,1 which is important for symptomatic patients. She had acute tubular necrosis with minimal urine output at the time of transfer. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 2018;29:92-100. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Penumbra ENGINE Intended Use Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Indigo System CAT RX | Penumbra Inc 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 . When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Alameda, CA 94502. J Vasc Interv Radiol. Director of Cardiac & Peripheral Cath Lab Do not use open or damaged packages. 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. Los Angeles, California Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. No conversations found. Return all damaged devices and packaging to the manufacturer/distributor. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . Contraindications Warnings 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. Additional Details. 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 Otherwise, this could result in degradation of the performance of this equipment. 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.
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