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As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 (Penumbra, Inc.) are indicated for the removal of fresh soft emboli and thrombi from vessels in the coronary and peripheral vasculature. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . Do not use in oxygen rich environment. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 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. These types of burns heal withing 5 or 6 days without permanent scarring. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Penumbra CAT6, Indigo system Aspiration Catheter 6F, 135cm - MedicalEcart Mechanical Thrombectomy | Medical Billing and Coding Forum - AAPC Contraindications There are no known contraindications. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. 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 sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. 3. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). 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 . The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. Circulation. Figure 2. INDIGO System LIGHTNING Aspiration Tubing Intended Use 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. Penumbra Aspiration Pump: Power aspiration with CAT RX has allowed us to successfully remove thrombus in patients presenting with acute coronary syndrome, establishing quick distal reperfusion and also visualization of the underlying stenosis. Penumbra's not relying on software alone. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Related Items. N Engl J Med. Device Name. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. 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). INDIGO Aspiration System Indication for Use Final angiogram with complete TIMI 3 flow after the use of CAT RX. Penumbra's high-performance aspiration catheters. QUICK VIEW. 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. 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. Saxon RR, Benenati JF, Teigen C, et al. 2023 Bryn Mawr Communications II, LLC. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 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. Mathews SJ, Brown C, Kolski B, et al. Interventional Cardiology Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Penumbra Indigo System | Vascular Thrombectomy Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Next Article This website is intended for US audience only. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. The patient remained on cangrelor with no need for tirofiban. Do not use kinked or damaged devices. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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. J Am Coll Cardiol. 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. Prior to use, please consult device labeling and instructions for use. Otherwise, this could result in degradation of the performance of this equipment. This website is intended for US audience only. PENUMBRA ENGINE Indication for Use The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. Figure 1. Return all damaged devices and packaging to the manufacturer/distributor. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Use only waterbased solvents for cleaning. The removal of fibrous, adherent or calcified material (e.g. excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . The CAT family of catheters is the foundation of Penumbras Indigo System. Further evaluation of the returned device revealed kinks in the catheter shaft. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . Figure 1. Penumbra, CAT8XTORQ115, Penumbra CAT8 Indigo Aspiration Catheter, XTorq 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). The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. 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. Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight Cedars Sinai Medical Center 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. Do not resterilize or reuse. 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. Do not use open or damaged packages. Mechanical Aspiration Thrombectomy Using the Penumbra CAT RX - PubMed 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. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. 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. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 Final angiogram after stent placement showing resolution of underlying disease. 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. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. St. Joseph Hospital Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Potential Adverse Events 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. Medical Director, Aortic Disease and Ischemic Limb Disease It will reduce service life of the Penumbra ENGINE. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. These pages are not intended for patients or for members of the general public. Photo: Courtesy of Business Wire. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. 2019;140:e774-e801. It will reduce the service life of the PENUMBRA ENGINE. Use prior to the Use By date. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Figure 2. 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. The Indigo Aspiration System is comprised of several devices: The Indigo System may be used as a first-line approach or rescue therapy for arterial and venous thrombotic events. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. 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; 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. The Indigo Aspiration System is contraindicated in: (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. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Initial angiogram of the right pulmonary artery showing pulmonary embolism. Penumbra Augments Vascular Franchise with Latest Indigo System Launch The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Figure 1. If the cause cannot be determined, withdraw the device or system as a unit. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Available in a selection of sizes, the CAT family can provide access to distal peripheral . 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. There was partial improvement of flow, but total occlusion remained. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. $399.00 EACH. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. CAT RX has allowed us to rethink how we approach these occluded SVGs. The results may vary depending on a variety of patient specific attributes. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. skin is red but turns white when pressed 1. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. Los Angeles, California Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. Use prior to the Use By date. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. K180412. 5, 19. Warnings/Precautions 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. 2015;372:1389-1398. Indication For Use Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. . Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. Alameda, CA 94502. 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. 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. SVG occlusions can be challenging to resolve using traditional treatment modalities. Initial angiogram showing high thrombus burden in the left circumflex artery. The CAT family of catheters is 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. Latest System Designed for Single Session Arterial Thrombus Removal News Indigo System | Penumbra Inc 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. Contraindications Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. 1. The system uses Penumbra's RED reperfusion catheters. 1. Brian Kolski, MD N Engl J Med. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: The INDIGO Aspiration Tubing: If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Disclosures: None. 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. CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. 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.
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