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The results may vary depending on a variety of patient specific attributes. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. 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. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. This is potentially more effective than diminished syringe-based aspiration. window.dataLayer = window.dataLayer || []; Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. J Vasc Interv Radiol. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 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. 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. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. Worcester, Massachusetts When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. Missouri Baptist Medical Center . Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. 0, and 37. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. 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. INDIGO Aspiration Catheters and Separators: 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 . We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. Precautions 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. 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. 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. Copyright 2022 Penumbra, Inc. All rights reserved. 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 . Throughout each case, Lightning provides procedural feedback via audiovisual cues. The Indigo System aspiration catheters are available in a range of lengths and diameters that, when connected to the Penumbra ENGINE pump, can atraumatically remove the thrombus present in various peripheral vascular beds. Do not reuse. 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. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 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. . Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. Contraindications 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. Figure 2. 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 product-specific content of this website is intended for use by healthcare professionals only. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. These pages are not intended for patients or for members of the general public. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . 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. 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. Initial angiogram showing high thrombus burden in the RCA. If the cause cannot be determined, withdraw the device or system as a unit. Final angiogram with complete TIMI 3 flow after the use of CAT RX. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. Do not use kinked or damaged devices. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . Figure 3. Indigo System Intended Use The healthcare firm said that the Indigo CAT RX Aspiration Catheters . Otherwise, this could result in degradation of the performance of this equipment. 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. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. 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. 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 . Final angiogram after mechanical thrombectomy with CAT8 and SEP8. Her heart rate was 110 beats per minute, elevated troponin levels at 4.5 ng/mL, and elevated brain natriuretic peptide at 1,164 pg/mL. Penumbra's Indigo Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Worcester, Massachusetts Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. This warranted the need for further innovation in the field of acute coronary syndrome.2 The goal of the Indigo System CAT RX mechanical aspiration system powered by the Penumbra ENGINE is to provide sustained aspiration for the duration of the procedure with enhanced deliverability to navigate tortuous anatomy and track to the distal coronary vasculature. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. 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. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. Figure 2. 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. 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. Potential Adverse Events Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 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). Suhail Dohad, MD, FACC Do not use kinked or damaged devices. suhail.dohad@cshs.org function gtag(){dataLayer.push(arguments);} The canister is intended for single use only. 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. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 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. Learn more about Lightning. 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. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Photo: Courtesy of Business Wire. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. Sista A. Indigo aspiration system for acute pulmonary embolism. 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. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. Bradenton Cardiology Center/Manatee Memorial Hospital Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. Ballad CVA Heart & Vascular Institute Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). 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. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Equipment is not safe for MR use. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. 1. Penumbra ENGINE Intended Use Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Vedantham S, Goldhaber SZ, Julian JA, et al. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. $399.00 EACH. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. Do not reuse. 1.10 Summary of Non-Clinical Data As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a (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. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. 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. 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 use in oxygen rich environment. Orange, California Initial angiogram showing high thrombus burden in the left circumflex artery. gtag('js', new Date()); 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.

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