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Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. The CAT family of catheters is the foundation of Penumbra's Indigo System. After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). PDF May 15, 2018 - Food And Drug Administration Penumbra's Newest Generation of Indigo Aspiration System Receives FDA Do not use open or damaged packages. Penumbra Aspiration Pump: Return all damaged devices and packaging to the manufacturer/distributor. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. Penumbra Announces U.S. Commercial Availability of INDIGO System Contraindications Not for use in the coronaries or the neurovasculature. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. If the cause cannot be determined, withdraw the device or system as a unit. 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 block bottom air vents. 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. gtag('js', new Date()); 0, 23. Penumbra, Inc. One Penumbra Place. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. Copyright 2023 Penumbra, Inc. All rights reserved. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Vascular Thrombectomy. Only use replacement fuse with correct rating (see Table 1 for fuse rating). 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. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . 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. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Indigo System CAT RX | Penumbra Inc 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 . Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. Do not resterilize or reuse. Use prior to the Use By date. skin is red but turns white when pressed Figure 2. 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. Mechanical Aspiration Thrombectomy Using the Penumbra CAT RX - PubMed 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. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. INDIGO Aspiration Tubing: Do not use kinked or damaged devices. The canister is intended for single use only. 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 device is intended for single use only. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. 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. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. Final angiogram with complete TIMI 3 flow after the use of CAT RX. 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. Alameda, CA 94502. 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. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. 2018;29:92-100. Indication For Use 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; and Suhail Dohad, MD, FACC. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Neuro | Penumbra, Inc. | Mechanical Thrombectomy & Embolization It will reduce service life of the Penumbra ENGINE. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION After one pass with CAT RX, the initial occlusion was removed. St. Joseph Hospital Waqas R. Qureshi, MD, MS window.dataLayer = window.dataLayer || []; Figure 1. PENUMBRA ENGINE Indication for Use With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Figure 3. 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. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. Do not re-infuse blood or fluid from the canister back into the patient. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . Do not use in oxygen rich environment. 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). Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. The complaint indicated that the cat8 was kinked during the procedure. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. INDIGO Aspiration System Intended Use Indigo System | Computer-Aided Mechanical Aspiration. Penumbra ENGINE Indication For Use CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. The treatment of arterial and venous thrombus is challenging. IN-DATE. function gtag(){dataLayer.push(arguments);} Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Jolly SS, Cairns JA, Yusuf S, et al. Figure 2. 5 and 94. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. 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. Penumbra CAT6, Indigo system Aspiration Catheter 6F, 135cm - MedicalEcart Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Randomized trial of primary PCI with or without routine manual thrombectomy. 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. Initial angiography revealed an occlusion of the distal RCA. The advantages of CAT RX with Penumbra ENGINE include the potential to remove the thrombus intact and reduce the potential of systemic embolization while also increasing the visualization of the underlying stenosis and distal vessel. The low-profile catheter and Penumbra ENGINE are easy to set up and use. The Indigo System and CAT8 - Endovascular Today 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. Lightning Flash: The Most Powerful and Advanced Mechanical Caution: 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. Worcester, Massachusetts Catheters & Separators. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. Penumbra, a US-based provider of advanced therapies, has enrolled the first patient into the CHEETAH clinical study, designed to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. We expect the results to further refine and improve our technique for mechanical aspiration and fine-tune the use of CAT RX for patients with high thrombus burden. 0, and 37. Indication For Use Separator 8, 150 cm Length, 0.072 in. Return all damaged devices and packaging to the manufacturer/distributor. Saint Louis, Missouri The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The product-specific content of this website is intended for use by healthcare professionals only. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. window.dataLayer = window.dataLayer || []; Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Do not use kinked or damaged devices. These pages are not intended for patients or for members of the general public. 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. PENUMBRA: SEP8 - Westcmr.com 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. Maintain a constant infusion of appropriate flush solution. Final angiogram after stent placement showing resolution of underlying disease. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. 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. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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. Gus Theodos, MD, FACC, FSCAI Distal OD. gtag('js', new Date()); The device is intended for single use only. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. 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). Director of Cardiac & Peripheral Cath Lab 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. INDIGO System LIGHTNING Aspiration Tubing Intended Use University of Massachusetts Medical School Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Available in a selection of sizes, the CAT family can enable access to distal peripheral vessels of the upper and lower extremities, including below the knee. Do not use kinked or damaged devices. Return all damaged devices and packaging to the manufacturer/distributor. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. The penumbra cat8 indigo system (cat8) was kinked approximately 4. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. Initial angiogram showing high thrombus burden in the RCA. Do not use open or damaged packages. 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. Do not use in an oxygen rich environment. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). INDIGO Aspiration System Indication for Use An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Applicant. If the cause cannot be determined, withdraw the device or system as a unit. No modification of this equipment is allowed. 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);}. Indigo System Catheters & Separators | Penumbra Inc The results may vary depending on a variety of patient specific attributes. 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 Final angiogram showing resolution of extensive thrombus burden. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. gus.theodos@bjc.org; @gtheodosmd Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. K180412. 1. Saxon RR, Benenati JF, Teigen C, et al. 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. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. 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. 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. 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. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . It will reduce the service life of the PENUMBRA ENGINE. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Next Article 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. The means of mains disconnect is to remove the power cord. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. 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. 8: Add BMK6F95M-NE . Thrombectomy & Embolization | Vascular Medical Devices - Penumbra Inc Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Indigo System - Vascupedia CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. 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. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. Circulation. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. Penumbra Recalls JET 7 Catheters with Xtra Flex -Risk of Mortality

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