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. Kingsport, Tennessee PDF May 15, 2018 - Food And Drug Administration Copyright 2022 Penumbra, Inc. All rights reserved. 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 re-infuse blood or fluid from the canister back into the patient. Additional Details. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon Penumbra ENGINE Intended Use Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. Jolly SS, Cairns JA, Yusuf S, et al. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. 2023 Bryn Mawr Communications II, LLC. Mechanical Thrombectomy. right-arrow 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. The complaint has been evaluated. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . To prevent fire or shock hazard, use a replacement power cord of equal rating. 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. 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. Lightning comes packaged with the Indigo CAT7 or CAT12. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . 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 The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Saxon RR, Benenati JF, Teigen C, et al. function gtag(){dataLayer.push(arguments);} Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. How Penumbra's smart-sucking algorithms and catheters speed up clot Figure 2. If repositioning of the INDIGO Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard catheter and guidewire techniques. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. 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. window.dataLayer = window.dataLayer || []; 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. Disclosures: None. 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. 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. 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 Disposable Separator 8, 150 cm Length, 0.072 in. 2018;29:92-100. Possible complications include, but are not limited to, the following: 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 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. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. Penumbra enrols first patient in CHEETAH Study of Indigo CAT RX device 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. Penumbra System Products - Medical Materials gtag('js', new Date()); Potential Adverse Events Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious . If repositioning of the INDIGO Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard catheter and guidewire techniques. No modification of this equipment is allowed. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. window.dataLayer = window.dataLayer || []; If the cause cannot be determined, withdraw the device or system as a unit. Jolly SS, Cairns JA, Lavi S, et al. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. Figure 3. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. Penumbra Indigo System | Vascular Thrombectomy To prevent fire or shock hazard, use a replacement power cord of equal rating. Separator 8, 150 cm Length, 0.072 in. IN-DATE. Final angiographic result of SVG. 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. Smidt Heart institute Prior to use, please consult device labeling and instructions for use. Final angiogram with complete TIMI 3 flow after the use of CAT RX. Do not use kinked or damaged devices. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. waqas.qureshi@umassmemorial.org 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. Orange, California 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. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Figure 2. Lightning Flash: The Most Powerful and Advanced Mechanical 0, and 37. Indigo System Intended Use Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. Precautions The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral . K180412. The CAT family of catheters is the foundation of Penumbra's Indigo system. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. PENUMBRA: CAT6 - WestCMR 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. Do not use in an oxygen rich environment. The following case reports highlight CAT RX in a multitude of unique applications as a primary frontline device to treat patients with 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. It will reduce the service life of the PENUMBRA ENGINE. J Am Coll Cardiol. Do not use kinked or damaged devices. The CAT family of catheters is the foundation of Penumbra's Indigo System. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. gus.theodos@bjc.org; @gtheodosmd 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. Do not use open or damaged packages. LIGHTNING Aspiration Tubing Indication for Use Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Brandenton, Florida N Engl J Med. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. A, Penumbra Indigo System Continuous Aspiration - ResearchGate Figure 1. Use prior to the Use By date. The CAT familyof catheters is the foundation of Penumbras Indigo System. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. INDIGO Aspiration System Indication for Use 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. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Penumbra's not relying on software alone. 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. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. The CAT family of catheters is the foundation of Penumbra's Indigo System. Not for use in the coronaries or the neurovasculature. Available in a selection of sizes, the CAT family can provide access to distal peripheral . Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F(x) Flow through left circumflex artery post-CAT RX. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. 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. 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. Contraindications CAT RX has allowed us to rethink how we approach these occluded SVGs. 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. (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. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Do not re-infuse blood or fluid from the canister back into the patient. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. 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. Do not resterilize or reuse. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Precautions The device is intended for single use only. Applicant. 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. INDIGO System LIGHTNING Aspiration Tubing Intended Use Warnings/Precautions With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Indication For Use The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. Do not block bottom air vents. 0, 23. The INDIGO Aspiration Tubing: SciELO - Brasil - Suporte mecnico extracorpreo e trombectomia por The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 2015;372:1389-1398. 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. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Director of Cardiac & Peripheral Cath Lab Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . CAT7 and CAT12 are the next generation of the Indigo System Catheters. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Initial angiography revealed an occlusion of the distal RCA. Penumbra Aspiration Pump: 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. Photo: Courtesy of Business Wire. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Interventional Cardiology 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. SVG occlusions can be challenging to resolve using traditional treatment modalities. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION 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. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. Penumbra ENGINE Indication For Use 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. There were no cases of 30-day cardiovascular death or post procedural stroke. 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. Mechanical Aspiration Thrombectomy Using the Penumbra CAT RX - PubMed The Swan-Ganz catheter was exchanged over a long V18 wire. J Vasc Interv Radiol. Indigo System CAT RX | Penumbra Inc 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). Potential Adverse Events Contraindications There are no known contraindications. Otherwise, this could result in degradation of the performance of this equipment. CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing 0, 24. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Potential Adverse Events Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Mechanical Power Aspiration With the Indigo - Endovascular Today The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . 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: function gtag(){dataLayer.push(arguments);} Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Medical Director, Aortic Disease and Ischemic Limb Disease MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 Penumbra, Inc. One Penumbra Place. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Disclosures: Consultant to Penumbra, Inc. A 59-year-old man with a history of hypertension and tobacco use presented with an inferior-posterior acute myocardial infarction (MI). 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. There was partial improvement of flow, but total occlusion remained. 3. 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 . The cat8 was kinked approximately 69. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. 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. No modification of this equipment is allowed. Penumbra Cat 8 - IndiaMART Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. kolskiwellness@gmail.com This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. Do not use kinked or damaged devices. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . Figure 3. UPC: Current Stock: This item is out of stock. Use prior to the Use By date. Use prior to the Use By date. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . 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. Director, Structural Heart 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. The Indigo System and CAT8 - Endovascular Today Initial angiogram showing high thrombus burden in the RCA. 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. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. Penumbra Aspiration Pump: Figure 1. Penumbra Announces U.S. Commercial Availability of INDIGO System The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems.
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