cat8 penumbra catheter

Do not resterilize or reuse. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. Missouri Baptist Medical Center Waqas R. Qureshi, MD, MS Return all damaged devices and packaging to the manufacturer/ distributor. 2019;140:e774-e801. 0, 26. Copyright 2023 Penumbra, Inc. All rights reserved. Possible complications include, but are not limited to, the following: gtag('js', new Date()); Final angiogram with complete TIMI 3 flow after the use of CAT RX. Saxon RR, Benenati JF, Teigen C, et al. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. Precautions The device is intended for single use only. 5, 19. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. To prevent fire or shock hazard, use a replacement power cord of equal rating. 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. Aspiration Tubing Intended Use 5, 21. The INDIGO Aspiration Tubing: Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. The cat8 was kinked approximately 69. Do not use in an oxygen rich environment. 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 healthcare firm said that the Indigo CAT RX Aspiration Catheters . 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. 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. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Figure 2. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . Otherwise, this could result in degradation of the performance of this equipment. Vedantham S, Goldhaber SZ, Julian JA, et al. The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Do not re-infuse blood or fluid from the canister back into the patient. J Vasc Interv Radiol. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8 DXE: Back to Search Results: Model Number CAT8XTORQ115KIT-S: Device Problems Break (1069); Physical Resistance/Sticking (4012) Patient Problem No Clinical Signs, Symptoms or Conditions (4582) Event Date 05/19/2021: To prevent fire or shock hazard, use a replacement power cord of equal rating. 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. 0 cm from the distal tip. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Maintain a constant infusion of appropriate flush solution. Return all damaged devices and packaging to the manufacturer/distributor. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. 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 . Otherwise, this could result in degradation of the performance of this equipment. 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 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. UMassMemorial University Campus If the cause cannot be determined, withdraw the device or system as a unit. This content is not intended to offer professional medical advice. 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. Penumbra ENGINE Intended Use Do not block bottom or back air vents. window.dataLayer = window.dataLayer || []; It will reduce the service life of the PENUMBRA ENGINE. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. 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 final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. University of Massachusetts Medical School The CAT family of catheters is the foundation of Penumbra's Indigo System. waqas.qureshi@umassmemorial.org window.dataLayer = window.dataLayer || []; Do not use kinked or damaged devices. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. LIGHTNING Aspiration Tubing Indication for Use 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). There are no contraindications. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. 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. gtag('js', new Date()); Penumbra Aspiration Pump: Contraindications Equipment is not safe for MR use. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. window.dataLayer = window.dataLayer || []; Return all damaged devices and packaging to the manufacturer/distributor. The results may vary depending on a variety of patient specific attributes. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Penumbra Aspiration Pump: Figure 3. 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. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. CAT7 and CAT12 are the next generation of the Indigo System catheters. Do not re-infuse blood or fluid from the canister back into the patient. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. Indication For Use Sista A. Indigo aspiration system for acute 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. 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 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. After IVUS, the stent was dilated to 3.75 mm. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. 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. Indigo Aspiration System Intended Use When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. The CAT family of catheters is the foundation of Penumbra's Indigo system. 0, and 37. St. Joseph Hospital 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. 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. Do not use kinked or damaged devices. These pages are not intended for patients or for members of the general public. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. Copyright 2022 Penumbra, Inc. All rights reserved. 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 patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 510 (k) Number. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Director, Structural Heart function gtag(){dataLayer.push(arguments);} This website is intended for US audience only. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. 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. 2018;29:92-100. The CAT family of catheters is the foundation of Penumbras Indigo System. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. Contraindications Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 This press release features multimedia. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Do not use kinked or damaged devices. The removal of fibrous, adherent or calcified material (e.g. 2. 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. INDIGO Aspiration Tubing: 0, 24. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). Prior to use, please consult device labeling and instructions for use. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Distal OD. 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. 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. Warnings Device Name. SVG occlusions can be challenging to resolve using traditional treatment modalities. Copyright 2023 Penumbra, Inc. All rights reserved. Potential Adverse Events Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Do not resterilize or reuse. Alameda, CA 94502. 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 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. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. . Mechanical thrombectomy was performed. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Indigo System | Computer-Aided Mechanical Aspiration. CAT RX has allowed us to rethink how we approach these occluded SVGs. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Copyright 2022 Penumbra, Inc. All rights reserved. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. N Engl J Med. 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. Initial angiography revealed an occlusion of the distal RCA. Penumbra's LANTERN Delivery Microcatheter integrates a highly trackable 2.6 F microcatheter with a high-flow lumen to facilitate confident delivery of Ruby Coil, POD, and Packing Coil even in tortuous anatomy. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. No modification of this equipment is allowed. Penumbra ENGINE Intended Use 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. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Potential Adverse Events When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. She was in a rehab facility prior to this new event recovering from her CVA. Separator 8, 150 cm Length, 0.072 in. . Possible complications include, but are not limited to, the following: acute vessel occlusion; air embolism; allergic reaction and anaphylaxis from contrast media or device material; anemia; arrhythmia; arteriovenous fistula; cardiac injury, cardiac perforation, cardiac tamponade; cardio-respiratory arrest; compartment syndrome; death; emboli; emergent surgery; foreign body embolization; hematoma or hemorrhage at access site; hemoptysis; hemorrhage; hypotension/hypertension; infarction leading to organ damage; infection; ischemia; myocardial infarction; neurological deficits including stroke; pneumothorax; pseudoaneurysm; renal impairment or acute renal failure from contrast media; residual thrombus due to inability to completely remove thrombus or control blood flow; respiratory failure; valvular damage; vessel spasm, thrombosis, dissection (intimal disruption), or perforation. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia.