Potential Adverse Events 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. These data are encouraging and have led to the next stage in data collection through the CHEETAH studya 400-patient, prospective, observational study evaluating the initial safety and performance of the Indigo Aspiration System CAT RX. 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. 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; If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 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. Return all damaged devices and packaging to the manufacturer/distributor. Contraindications There are no contraindications. 22. Pinterest; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm Penumbra System) Model #: CAT8XTORQ115KIT OEM: Penumbra System Expiration Date: 2022 Size : 8Fr x 115cm . 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. Figure 2. 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. Figure 1. The deliverability and continuous aspiration power were essential to achieving restoration of flow supporting a positive patient outcome to help heal this case of CLI. QUICK VIEW. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. Mechanical Thrombectomy. 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. Do not use kinked or damaged devices. Medical Director, Aortic Disease and Ischemic Limb Disease Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Warnings/Precautions The canister is intended for single use only. BJC Cardiology Mathews SJ, Brown C, Kolski B, et al. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . skin is red but turns white when pressed The large aspiration lumen and highly trackable, low-profile design coupled with the power of the Penumbra ENGINE resulted in the successful removal of the emboli in one pass. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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 . The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. left-arrow 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 patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. Giri J, Sista AK, Weinberg J, et al. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. If the cause cannot be determined, withdraw the device or system as a unit. Do not use open or damaged packages. Prior to use, please consult device labeling and instructions for use. SVG occlusions can be challenging to resolve using traditional treatment modalities. 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. Do not use kinked or damaged devices. There were no cases of 30-day cardiovascular death or post procedural stroke. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Learn more about Lightning. Latest System Designed for Single Session Arterial Thrombus Removal News 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. Indigo System CAT RX | Penumbra Inc Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. 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 Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. The procedure was completed with the same catheter. 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. Vedantham S, Goldhaber SZ, Julian JA, et al. 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. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Use only waterbased solvents for cleaning. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Worcester, Massachusetts Potential Adverse Events 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. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. 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. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). 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 . Not for use in the coronaries or the neurovasculature. Return all damaged devices and packaging to the manufacturer/distributor. Director of Cardiac Catheterization Lab, PERT & Structural Heart Worcester, Massachusetts 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. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. 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 the PENUMBRA ENGINE. Missouri Baptist Medical Center 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. Penumbra ENGINE Intended Use 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. PDF May 15, 2018 - Food And Drug Administration Figure 1. 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. 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. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. 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. Resterilization and/or reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location. Use prior to the Use By date. . Distal emboli causing PDA occlusion after manual aspiration. Copyright 2023 Penumbra, Inc. All rights reserved. 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. Contraindications There are no known contraindications. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. 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. Mechanical Aspiration Thrombectomy Using the Penumbra CAT RX - PubMed The product-specific content of this website is intended for use by healthcare professionals only. Units in stock: 1. Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. 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. 510 (k) Number. Flow through left circumflex artery post-CAT RX. Potential Adverse Events N Engl J Med. Available in a selection of sizes, the CAT family can provide access to distal peripheral . 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. 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. Results of EXTRACT-PE Trial presented at Vascular InterVentional Advances (VIVA) Annual Meeting Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced that the EXTRACT-PE trial successfully met the primary endpoints, demonstrating the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with . Return all damaged devices and packaging to the manufacturer/ distributor. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. Do not reuse. Penumbra Aspiration Pump: Return all damaged devices and packaging to the manufacturer/distributor. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. Use prior to the Use By date. These pages are not intended for patients or for members of the general public. 0 cm from the distal tip. Additional Details. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . 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. Distal OD, Sterile, Single-Use, Disposable, For CAT8 Penumbra Devices, Indigo Aspiration Catheters, Removal of Fresh, Soft Emboli and Thrombi from Vessels of Peripheral Arterial and Venous Systems Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight The INDIGO SEPARATOR is not intended for use as a guidewire. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Use prior to the Use By date. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. Copyright 2022 Penumbra, Inc. All rights reserved. PENUMBRA: CAT3 - westcmr.com Penumbra's not relying on software alone. 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. Lightning Flash: The Most Powerful and Advanced Mechanical Created with Sketch. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the Penumbra ENGINE as they can interfere with and result in degradation of the performance of the equipment. 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. 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. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Separator 8, 150 cm Length, 0.072 in. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Waqas R. Qureshi, MD, MS Do not resterilize or reuse. Enter your email address and we will contact you. 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 initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). After one pass with mechanical thrombectomy using CAT RX, the thrombus was removed and flow was restored to the pedal arch via the plantar posterior tibial artery (Figure 2 and Figure 3). The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. 0, 23. This content is not intended to offer professional medical advice. Ballad CVA Heart & Vascular Institute The patient remained on cangrelor with no need for tirofiban. The CAT family of catheters is the foundation of Penumbra's Indigo system. 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. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use 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. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. St. Joseph Hospital Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 0, 24. . 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 . chronic clot, atherosclerotic plaque) The treatment of arterial and venous thrombus is challenging. The complaint has been evaluated. This website is intended for US audience only. Circulation. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. This ability of lobar thrombectomy likely allowed EXTRACT-PE to be the first endovascular IDE, pulmonary embolism trial that has reported statistically significant reduction in on-table systolic pulmonary artery pressures. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. The CAT family of catheters is the foundation of Penumbras Indigo System. Los Angeles, California Figure 2. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. 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. Neuro | Penumbra, Inc. | Mechanical Thrombectomy & Embolization Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. 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 ENGINE Intended Use 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. Conclusions: evaluation of the cat8 revealed that the device was fractured. 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. Randomized trial of primary PCI with or without routine manual thrombectomy. The means of mains disconnect is to remove the power cord. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). 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 Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. The Indigo Separator 4 is not intended for use as a guidewire. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. 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. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. UPC: Current Stock: . 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. Precautions The device is intended for single use only. Do not use open or damaged packages. Warnings The product-specific content of this website is intended for use by healthcare professionals only. Potential Adverse Events SciELO - Brasil - Suporte mecnico extracorpreo e trombectomia por 1. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 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. Do not use in oxygen rich environment. Initial angiography revealed an occlusion of the distal RCA. There are no contraindications. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). Mechanical Power Aspiration With the Indigo - Endovascular Today 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. 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. Device Name. Sista A. Indigo aspiration system for acute pulmonary embolism. Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Do not block bottom or back air vents. 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. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Indigo System CAT RX tracking through the distal posterior tibial artery. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. INDIGO Aspiration System Intended Use Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. 5 and 94. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology.
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