cat8 penumbra catheter

Figure 2. Figure 2. Penumbra's not relying on software alone. 2018;72:1589-1596. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 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. 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. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. The product-specific content of this website is intended for use by healthcare professionals only. 2015;372:1389-1398. The low-profile catheter and Penumbra . IN-DATE. $399.00 EACH. Initial angiogram showing high thrombus burden in the RCA. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. 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 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. 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. Cedars Sinai Medical Center After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. The pulmonary capillary wedge pressure is 10 mmHg. The product-specific content of this website is intended for use by healthcare professionals only. 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. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Utility of a power aspiration-based extraction technique as an initial and secondary approach in the treatment of peripheral arterial thromboembolism: results of the multicenter PRISM Trial. 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). Do not resterilize or reuse. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. Do not resterilize or reuse. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Do not use kinked or damaged devices. 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. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. The INDIGO SEPARATOR is not intended for use as a guidewire. Figure 1. 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. Created with Sketch. 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. 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. 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. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 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 complaint has been evaluated. 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. window.dataLayer = window.dataLayer || []; Initial angiography revealed an occlusion of the distal RCA. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Jolly SS, Cairns JA, Lavi S, et al. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 2018;29:92-100. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Do not use kinked or damaged devices. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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. 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. o The Penumbra Indigo System Separator is intended for use with our Indigo System's family of catheters to enable the removal of a wide range of thrombus. The removal of fibrous, adherent or calcified material (e.g. Copyright 2022 Penumbra, Inc. All rights reserved. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Do not use in an oxygen rich environment. 0 cm from the distal tip. 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. 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. suhail.dohad@cshs.org Separator 8, 150 cm Length, 0.072 in. Penumbra ENGINE Intended Use UMassMemorial University Campus Gus Theodos, MD, FACC, FSCAI Mechanical Thrombectomy. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Order Qty. 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. 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. Catheters & Separators. 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. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Brian Kolski, MD 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. Circulation. Copyright 2023 Penumbra, Inc. All rights reserved. This content is not intended to offer professional medical advice. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. CAT8XTORQ115KIT-NS. Do not use open or damaged packages. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. Equipment is not safe for MR use. Do not use in an oxygen rich environment. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. Copyright 2023 Penumbra, Inc. All rights reserved. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. SVG occlusions can be challenging to resolve using traditional treatment modalities. 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. Relying on a different mechanism of action, power aspiration with CAT RX and Penumbra ENGINE was able to extract the thrombus intact; thus restoring flow through the graft. 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. 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 Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Kingsport, Tennessee The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Do not use kinked or damaged devices. window.dataLayer = window.dataLayer || []; TIMI 3 flow was achieved in 88% of cases. Do not resterilize or reuse. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal 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. INDIGO Aspiration Tubing: 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. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 0, 23. Precautions The device is intended or single use only. The Swan-Ganz catheter was exchanged over a long V18 wire. Learn more about Lightning. LIGHTNING Aspiration Tubing Indication for Use Return all damaged devices and packaging to the manufacturer/distributor. Copyright 2022 Penumbra, Inc. All rights reserved. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. Final angiogram with complete TIMI 3 flow after the use of CAT RX. function gtag(){dataLayer.push(arguments);} Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. CAT7 and CAT12 are the next generation of the Indigo System Catheters. 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. Potential Adverse Events Next Article 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.). 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. University of Massachusetts Medical School The patient remained on cangrelor with no need for tirofiban. The device is intended for single use only. Lightning 12 and Lightning 8 expand the already broad offering of CAT8, CATD, CAT6, CAT5, and CAT3 and are paired with Penumbra ENGINE, the company's proprietary continuous, mechanical vacuum . 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). Initial angiogram of the right pulmonary artery showing pulmonary embolism. Penumbra Aspiration Pump: The healthcare firm said that the Indigo CAT RX Aspiration Catheters . If the cause cannot be determined, withdraw the device or system as a unit. The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. 5 and 94. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. There are no contraindications. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Suhail Dohad, MD, FACC Do not use open or damaged packages. 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. Return all damaged devices and packaging to the manufacturer/distributor. Learn more about Lightning. . 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. Saxon RR, Benenati JF, Teigen C, et al. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. The procedure can be performed quickly,1 which is important for symptomatic patients. 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. Sista A. Indigo aspiration system for acute pulmonary embolism. Lightning comes packaged with the Indigo CAT7 or CAT12. Disclosures: Consultant to Penumbra, Inc. A 75-year-old woman with a history of diabetes, hypertension, and dyslipidemia presented with Rutherford class 5 critical limb ischemia (CLI) due to a nonhealing ulcer. 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. The CAT familyof catheters is the foundation of Penumbras Indigo System. Copyright 2023 Penumbra, Inc. All rights reserved. UPC: Current Stock: This item is out of stock. The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum to our catheters to remove thrombus in vessels of various sizes. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. 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. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. 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. 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. Power aspiration with CAT RX has allowed us to successfully remove thrombus in patients presenting with acute coronary syndrome, establishing quick distal reperfusion and also visualization of the underlying stenosis. The device is intended for single use only. Applicant. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. 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 initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). 1. 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. PENUMBRA ENGINE Intended Use Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. The cerebral vasculature Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Penumbra ENGINE. In patients with submassive pulmonary embolism with compromised right ventricular function and elevated biomarkers, the Indigo System is an excellent frontline tool offering a safe and effective1 treatment option. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305

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