Do not use kinked or damaged devices. 2018;29:92-100. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Maintain a constant infusion of appropriate flush solution. 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. Jawairia Sahar K. Mirza, MBBS Gus Theodos, MD, FACC, FSCAI Flow through left circumflex artery post-CAT RX. The CAT family of catheters is the foundation of Penumbras Indigo System. Randomized trial of primary PCI with or without routine manual thrombectomy. Figure 1. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. 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. 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. Do not reuse. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Do not block bottom air vents. Missouri Baptist Medical Center These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Further evaluation of the returned device revealed kinks in the catheter shaft. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Otherwise, this could result in degradation of the performance of this equipment. Precautions St. Joseph Hospital Otherwise, this could result in degradation of the performance of this equipment. . 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. 3. Use prior to the Use By date. left-arrow Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Indigo System Intended Use Chris Metzger, MD If the cause cannot be determined, withdraw the device or system as a unit. chronic clot, atherosclerotic plaque) The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Warnings Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. Equipment is not safe for MR use. Do not use open or damaged packages. 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. The low-profile catheter and Penumbra . The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. 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 . Contraindications Not for use in the coronaries or the neurovasculature. Use prior to the Use By date. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Units in stock: 1. Figure 1. Engineered with neuro-tracking technology, CAT RX is designed to navigate tortuous anatomy and track to distal coronary vasculature while maintaining sustained mechanical aspiration with the Penumbra ENGINE. 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. The Swan-Ganz catheter was exchanged over a long V18 wire. 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. Ballad CVA Heart & Vascular Institute The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Disclosures: None. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Los Angeles, California Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. 0, 24. UPC: Current Stock: . gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Created with Sketch. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. Giri J, Sista AK, Weinberg J, et al. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. 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. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Distal OD. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the 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. kolskiwellness@gmail.com Return all damaged devices and packaging to the manufacturer/distributor. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. Maintain a constant infusion of appropriate flush solution. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. The procedure can be performed quickly,1 which is important for symptomatic patients. 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. right-arrow After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. 5, 21. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. She had acute tubular necrosis with minimal urine output at the time of transfer. window.dataLayer = window.dataLayer || []; Lightning 7 expands Penumbra's offering of the Indigo Aspiration System with Intelligent Aspiration for mechanical thrombectomy and is designed for single session arterial thrombus removal. Potential Adverse Events If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. K180412. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. No modification of this equipment is allowed. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Do not use in oxygen rich environment. 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. Categories. Only use replacement fuse with correct rating (see Table 1 for fuse rating). The Indigo System CAT RX was the preferred choice for mechanical aspiration thrombectomy to remove the distal emboli below the knee in the posterior tibial artery. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. 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. 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 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. N Engl J Med. LIGHTNING Aspiration Tubing Indication for Use The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Bradenton Cardiology Center/Manatee Memorial Hospital Related Items. 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. 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. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. The means of mains disconnect is to remove the power cord. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 These pages are not intended for patients or for members of the general public. 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. Brandenton, Florida Warnings/Precautions Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. There were no cases of 30-day cardiovascular death or post procedural stroke. 1. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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, and 37. Ultrasound-guided access was obtained through the right femoral vein. The INDIGO SEPARATOR is not intended for use as a guidewire. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). 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. IN-DATE. 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. Figure 2. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Return all damaged devices and packaging to the manufacturer/distributor. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Figure 2. 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 . window.dataLayer = window.dataLayer || []; Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. . Cedars Sinai Medical Center $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . 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 Computer-Aided Aspiration comes packaged with CAT7 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. 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. 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 treatment of arterial and venous thrombus is challenging. TIMI 3 flow was achieved in 88% of cases. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. 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. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. Figure 1. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Return all damaged devices and packaging to the manufacturer/distributor. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Initial angiogram showing high thrombus burden in the left circumflex artery. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). 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. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. 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. Contraindications There are no contraindications. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. INDIGO Aspiration Tubing: The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. 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. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. Learn more about Lightning. Do not use open or damaged packages. INDIGO Aspiration System Intended Use Final angiogram with complete TIMI 3 flow after the use of CAT RX. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. Figure 3. Penumbras IndigoAspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. QUICK VIEW. 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.

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