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. Due to our experience in such cases, sustained aspiration with the Indigo System CAT RX with Penumbra ENGINE has quickly become our frontline device, challenging the traditional method of manual aspiration in patients with thrombi and emboli in the coronary arteries. 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. 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. There were no cases of 30-day cardiovascular death or post procedural stroke. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Prior to use, please consult device labeling and instructions for use. The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. 2017;377:2240-2252. function gtag(){dataLayer.push(arguments);} Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. . J Am Coll Cardiol. Brian Kolski, MD kolskiwellness@gmail.com 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. UPC: Current Stock: . gtag('js', new Date()); Director of Cardiac & Peripheral Cath Lab Figure 1. The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. Initial angiography revealed an occlusion of the distal RCA. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. IN-DATE. 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. Contraindications 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. 2018;29:92-100. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . 5 and 94. 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. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. 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. INDIGO Aspiration Tubing: 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. The device is intended for single use only. The means of mains disconnect is to remove the power cord. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. 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. window.dataLayer = window.dataLayer || []; Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Penumbra ENGINE Indication For Use Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Copyright 2023 Penumbra, Inc. All rights reserved. Related Items. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. To prevent fire or shock hazard, use a replacement power cord of equal rating. 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. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. 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. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. The product-specific content of this website is intended for use by healthcare professionals only. 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. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Possible complications include, but are not limited to, the following: The canister is intended for single use only. She had acute tubular necrosis with minimal urine output at the time of transfer. Do not use in an oxygen rich environment. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Distal OD. Conclusions: evaluation of the cat8 revealed that the device was fractured. Final angiographic result of SVG. Do not use kinked or damaged devices. Waqas R. Qureshi, MD, MS UMassMemorial University Campus Penumbra's high-performance aspiration catheters. N Engl J Med. 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. Do not resterilize or reuse. 1. Not for use in the coronaries or the neurovasculature. function gtag(){dataLayer.push(arguments);} The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). Smidt Heart institute Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum to our catheters to remove thrombus in vessels of various sizes. 0 cm from the distal tip. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Figure 1. Penumbra Aspiration Pump: 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). System Chair, Clinical Research gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. Indigo System CAT RX tracking through the distal posterior tibial artery. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. 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. Circulation. Initial angiogram showing high thrombus burden in the RCA. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. The removal of fibrous, adherent or calcified material (e.g. Do not reuse. 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. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . 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. The cerebral vasculature 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. Potential Adverse Events TIMI 3 flow was achieved in 88% of cases. 3. 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. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Figure 3. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. The procedure was completed with the same catheter. Sista A. Indigo aspiration system for acute pulmonary embolism. Initial angiogram of the right pulmonary artery showing pulmonary embolism. The pulmonary capillary wedge pressure is 10 mmHg. Only use replacement fuse with correct rating (see Table 1 for fuse rating).