cat8 penumbra catheter

Jolly SS, Cairns JA, Lavi S, et al. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . 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. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. 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 open or damaged packages. The product-specific content of this website is intended for use by healthcare professionals only. sjaymathewsmd@gmail.com 2: Add If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. 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 . Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. Copyright 2023 Penumbra, Inc. All rights reserved. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. 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. Further evaluation of the returned device revealed kinks in the catheter shaft. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. 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. 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. Indication For Use Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. 2. If the cause cannot be determined, withdraw the device or system as a unit. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Do not use kinked or damaged devices. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. If the cause cannot be determined, withdraw the device or system as a unit. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Final angiogram after stent placement showing resolution of underlying disease. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Copyright 2022 Penumbra, Inc. All rights reserved. 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. Initial angiogram showing high thrombus burden in the RCA. waqas.qureshi@umassmemorial.org PENUMBRA ENGINE Indication for Use 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. Otherwise, this could result in degradation of the performance of this equipment. PENUMBRA ENGINE Intended Use Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). Potential Adverse Events Penumbra ENGINE Intended Use Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Order Qty. The low-profile catheter and Penumbra ENGINE are easy to set up and use. Mechanical Thrombectomy. Use prior to the Use By date. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Do not use kinked or damaged devices. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. Potential Adverse Events 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. Equipment is not safe for MR use. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. 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. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Potential Adverse Events Indigo Disposable Separator 8, 150 cm Length, 0.072 in. . Figure 3. Return all damaged devices and packaging to the manufacturer/distributor. If the cause cannot be determined, withdraw the device or system as a unit. Manual aspiration suffers from diminished aspiration force as fluid fills in the syringe, potentially resulting in systemic embolization during catheter removal, as shown in the TOTAL trial published in 2015 (Figure 1).1 Subgroup analysis of patients with high thrombus burden was explored that highlighted the potential for improved outcomes. 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: After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. Do not reuse. window.dataLayer = window.dataLayer || []; Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Use only waterbased solvents for cleaning. 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. INDIGO Aspiration System Intended Use At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Possible complications include, but are not limited to, the following: It will reduce the service life of the PENUMBRA ENGINE. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. window.dataLayer = window.dataLayer || []; Missouri Baptist Medical Center INDIGO Aspiration System Intended Use Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Precautions The device is intended for single use only. Potential Adverse Events Orange, California 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. 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. Possible complications include, but are not limited to, the following: LIGHTNING Aspiration Tubing is a sterile aspiration tubing component of the INDIGO Aspiration System and 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. 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. 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. 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. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Copyright 2023 Penumbra, Inc. All rights reserved. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 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 . 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. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. Do not block bottom or back air vents. gtag('js', new Date()); Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Figure 2. No conversations found. 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 CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. This website is intended for US audience only. After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. 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 allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Mechanical power aspiration with the Indigo System CAT RX (Penumbra, Inc.), introduced in 2018, continues to gain in popularity as a solution for high thrombus burden in the coronaries. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. 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 Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Indigo System CAT RX tracking through the distal posterior tibial artery. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. 2017;377:2240-2252. Penumbra Aspiration Pump: Use prior to the Use By date. This content is not intended to offer professional medical advice. 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. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. 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. N Engl J Med. St. Joseph Hospital Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. 2018;72:1589-1596. 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). Do not reuse. It will reduce service life of the Penumbra ENGINE. 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 Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. After IVUS, the stent was dilated to 3.75 mm. 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 in an oxygen rich environment. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Final angiogram with complete TIMI 3 flow after the use of CAT RX. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). (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. 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. 0, 24. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arrhythmia; arteriovenous fistula; cardiac injury; cardio-respiratory arrest; death; device malfunction; distal embolization; emboli; excessive blood loss; 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; hemoptysis; respiratory failure; thromboembolic events. Use prior to the Use By date. 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. 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. The results may vary depending on a variety of patient specific attributes. Conclusions: evaluation of the cat8 revealed that the device was fractured. This website is intended for US audience only. Related Items. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. N Engl J Med. 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. Figure 1. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). 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 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. 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. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. 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. 5, 19. Enter your email address and we will contact you. 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. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. University of Massachusetts Medical School Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. J Am Coll Cardiol. Penumbra's not relying on software alone. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. CAT RX has allowed us to rethink how we approach these occluded SVGs. Launches Indigo System Lightning 12 in U.S. Appoints Corey L. Teigen, M.D., as Chief Scientific Officer and James F. Benenati, M.D., FSIR, as Chief Medical Officer Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced its next phase for vascular franchise growth with U.S. commercial availability of the Indigo System Lightning 12 and . Throughout each case, Lightning provides procedural feedback via audiovisual cues. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. 0 cm from the hub. A 65-cm 8-F Destination sheath (Terumo Interventional Systems) was advanced into the right pulmonary artery, first over a telescoping balloon tip catheter and stiff angle Glidewire (Terumo Interventional Systems). This press release features multimedia. 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Suhail Dohad, MD, FACC 2. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. gtag('js', new Date()); 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. Do not use open or damaged packages. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. CAT RX is an essential tool in our percutaneous coronary armamentarium. Mathews SJ, Brown C, Kolski B, et al. Giri J, Sista AK, Weinberg J, et al. The INDIGO SEPARATOR is not intended for use as a guidewire. 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. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. window.dataLayer = window.dataLayer || [];

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