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Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. window.dataLayer = window.dataLayer || []; The Penumbra CAT RX catheter was used in a total of 34 patients, with 71% STEMI, 23% NSTEMI, 3% UA, and 3% new onset heart failure. Do not resterilize or reuse. gtag('js', new Date()); Use prior to the Use By date. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Do not use kinked or damaged devices. Medical Director, Aortic Disease and Ischemic Limb Disease 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 . INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use function gtag(){dataLayer.push(arguments);} Applicant. 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. After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. Mechanical thrombectomy was performed. 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. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Missouri Baptist Medical Center Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. Potential Adverse Events The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. 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. UPC: Current Stock: . After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. If the cause cannot be determined, withdraw the device or system as a unit. Final angiographic result of SVG. To prevent fire or shock hazard, use a replacement power cord of equal rating. Do not use kinked or damaged devices. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 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. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. J Vasc Interv Radiol. Precautions The device is intended for single use only. Cedars Sinai Medical Center The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. The device is intended for single use only. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. The CAT family of catheters is the foundation of Penumbra's Indigo system. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 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. The product-specific content of this website is intended for use by healthcare professionals only. INDIGO Aspiration System Indication for Use Contraindications There are no known contraindications. 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. Return all damaged devices and packaging to the manufacturer/distributor. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Copyright 2022 Penumbra, Inc. All rights reserved. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. If repositioning of the INDIGO CAT RX Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard guidewire techniques. 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. Jawairia Sahar K. Mirza, MBBS 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. 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. PENUMBRA ENGINE Indication for Use Do not use open or damaged packages. Otherwise, this could result in degradation of the performance of this equipment. The Swan-Ganz catheter was exchanged over a long V18 wire. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. To prevent fire or shock hazard, use a replacement power cord of equal rating. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 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. 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. Figure 2. The newest indication for the Indigo System is the treatment of pulmonary embolism; this indication comes on the heels of the promising results of the EXTRACT-PE trial. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 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. Do not reuse. Indigo System Intended Use Mathews SJ, Brown C, Kolski B, et al. 2. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. 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). This content is not intended to offer professional medical advice. We presented our initial experience at the American College of Cardiologys (ACC) 68th Annual Scientific Session, which showed promising results for mechanical power aspiration for thrombus removal during percutaneous intervention using CAT RX.3 This retrospective case series included 59 patients from four institutions around the United States. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. 2. The Indigo Aspiration System is contraindicated in: Final angiogram after stent placement showing resolution of underlying disease. infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; respiratory failure; peripheral thromboembolic events. The Indigo System 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. Do not resterilize or reuse. BJC Cardiology The healthcare firm said that the Indigo CAT RX Aspiration Catheters . PENUMBRA ENGINE Intended Use 1. Figure 2. 2018;72:1589-1596. In a retrospective analysis of patients in our practice with fresh thrombus burden, we have observed TIMI 3 restored when using CAT RX frontline.1 This is another positive patient outcome with the use of CAT RX in a case of high thrombus burden. 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. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. The Indigo System Catheter CAT8 was used across 22 sites in the United States in patients with submassive PE who did not receive thrombolytics (98.3%), with a . 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. With a maximised inner diameter of 0.08 (2.1 mm) and a 7 French (2.3 mm) outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. Vascular Thrombectomy. Figure 3. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. Contraindications Not for use in the coronaries or the neurovasculature. Potential Adverse Events The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). UPC: Current Stock: This item is out of stock. Because the patient was not a candidate for thrombolysis, the decision was made to intervene with the Indigo System CAT8XTORQ115 and SEP 8, which were advanced sequentially into the right then left pulmonary artery. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. 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. Potential Adverse Events The complaint indicated that the cat8 was kinked during the procedure. Additional Details. Initial angiogram showing high thrombus burden in the left circumflex artery. Throughout each case, Lightning provides procedural feedback via audiovisual cues. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Two passes of CAT RX with the Penumbra ENGINE resulted in TIMI 3 flow restoration and retrieval of the distal emboli from the PDA (Figure 3). Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. 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. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. Equipment is not safe for MR use. Vedantham S, Goldhaber SZ, Julian JA, et al. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 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. 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. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. The product-specific content of this website is intended for use by healthcare professionals only. gtag('js', new Date()); Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Mathews SJ, Brown C, Kolski B, et al. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. The results may vary depending on a variety of patient specific attributes. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Alameda, CA 94502. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. Penumbra's not relying on software alone. N Engl J Med. If the cause cannot be determined, withdraw the device or system as a unit. INDIGO Aspiration Tubing: (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. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. 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. Latest System Designed for Single Session Arterial Thrombus Removal News Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . The INDIGO SEPARATOR is not intended for use as a guidewire. A 65-cm 8-F Destination sheath (Terumo Interventional Systems) was advanced into the right pulmonary artery, first over a telescoping balloon tip catheter and stiff angle Glidewire (Terumo Interventional Systems). The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). Figure 1. 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. Equipment is not safe for MR use. 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. 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. Director of Cardiac & Peripheral Cath Lab Learn more about Lightning. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. Available in a selection of sizes, the CAT family can provide access to distal peripheral . INDIGO Aspiration System Intended Use Indication For Use 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. 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 procedure time was short (median of 37 minutes)the shortest demonstrated so far in an investigational device exemption (IDE) trial on patients with pulmonary embolism. 0, 24. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon These pages are not intended for patients or for members of the general public. 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). 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. Penumbra, Inc. One Penumbra Place. Device Name. 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. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. 510 (k) Number. 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. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. Contraindications There are no known contraindications. The system uses Penumbra's RED reperfusion catheters. . Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. 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. Units in stock: 1. 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. The procedure can be performed quickly,1 which is important for symptomatic patients. The patient remained on cangrelor with no need for tirofiban. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Do not use open or damaged packages. Kingsport, Tennessee Figure 2. This is potentially more effective than diminished syringe-based aspiration. 3. Learn more about Lightning. 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);}. The Indigo System CAT RX was the preferred choice for mechanical aspiration thrombectomy to remove the distal emboli below the knee in the posterior tibial artery. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. 1. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 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 median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. 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. 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.

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