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. INDIGO Aspiration System Intended Use When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Ultrasound-guided access was obtained through the right femoral vein. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . CAT RX has allowed us to rethink how we approach these occluded SVGs. The cat8 was kinked approximately 69. Do not resterilize or reuse. 2015;372:1389-1398. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. S. Jay Mathews, MD, MS, FACC 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Prior to use, please consult device labeling and instructions for use. 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. Use prior to the Use By date. 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. University of Massachusetts Medical School Final angiogram after stent placement showing resolution of underlying disease. Figure 3. 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 The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). 2019;140:e774-e801. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Do not use kinked or damaged devices. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. Randomized trial of primary PCI with or without routine manual thrombectomy. The procedure was completed with the same catheter. The INDIGO SEPARATOR is not intended for use as a guidewire. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Contraindications Not for use in the coronaries or the neurovasculature. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 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. N Engl J Med. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. There was partial improvement of flow, but total occlusion remained. . Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Penumbra ENGINE. 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. Next Article The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. function gtag(){dataLayer.push(arguments);} She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. After IVUS, the stent was dilated to 3.75 mm. Conclusions: evaluation of the cat8 revealed that the device was fractured. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Contraindications Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Figure 1. Order Qty. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Ballad CVA Heart & Vascular Institute Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. 3. Otherwise, this could result in degradation of the performance of this equipment. Penumbra ENGINE Intended Use Contraindications The pain became more intense and constant, so he presented to the ED. 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 use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. 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. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. Medical Director, Aortic Disease and Ischemic Limb Disease The device is intended for single use only. Initial angiogram showing high thrombus burden in the left circumflex artery. The complaint has been evaluated. Contraindications There are no contraindications. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. 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. Related Items. The INDIGO SEPARATOR is not intended for use as a guidewire. Copyright 2022 Penumbra, Inc. All rights reserved. 1. kolskiwellness@gmail.com Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. Copyright 2023 Penumbra, Inc. All rights reserved. Do not use in oxygen rich environment. 0, 23. 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. Do not advance, retract or use any component of the INDIGO 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. The Indigo System Catheter CAT8 was used across 22 sites in the United States in patients with submassive PE who did not receive thrombolytics (98.3%), with a . Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Potential Adverse Events A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. The low-profile catheter and Penumbra . Aspiration or disruption of thrombus with traditional diminished syringe-based aspiration or other mechanical devices is difficult, often incomplete, and has been associated with high complication rates.1 Use of medical therapy, such as powerful anticoagulants and thrombolytics (ie, tissue plasminogen activator), may carry a high risk of bleeding.2 The Indigo System was designed to provide sustained aspiration with Penumbra ENGINE to effectively remove thrombus, while reducing the risk of bleeding complications.3 The Indigo System utilizes atraumatic catheters varying in diameters from 3.4 to 8 F and lengths ranging from 50 to 150 cm. 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 . CAT7 and CAT12 are the next generation of the Indigo System Catheters. 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. N Engl J Med. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Worcester, Massachusetts Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 0 cm from the hub. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. Tareq Kass-Hout. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. Return all damaged devices and packaging to the manufacturer/distributor. Los Angeles, California 5, 19. Distal emboli causing PDA occlusion after manual aspiration. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). 2: Add Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Precautions 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. Do not use kinked or damaged devices. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. 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 resterilize or reuse. Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. 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. Use prior to the Use By date. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. Director of Cardiac & Peripheral Cath Lab If the cause cannot be determined, withdraw the device or system as a unit. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. 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. Mechanical coronary aspiration was performed frontline with CAT RX and Penumbra ENGINE to remove the high thrombus burden. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Figure 2. Do not use in oxygen rich environment. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. Possible complications include, but are not limited to, the following: acute vessel occlusion; air embolism; allergic reaction and anaphylaxis from contrast media or device material; anemia; arrhythmia; arteriovenous fistula; cardiac injury, cardiac perforation, cardiac tamponade; cardio-respiratory arrest; compartment syndrome; death; emboli; emergent surgery; foreign body embolization; hematoma or hemorrhage at access site; hemoptysis; hemorrhage; hypotension/hypertension; infarction leading to organ damage; infection; ischemia; myocardial infarction; neurological deficits including stroke; pneumothorax; pseudoaneurysm; renal impairment or acute renal failure from contrast media; residual thrombus due to inability to completely remove thrombus or control blood flow; respiratory failure; valvular damage; vessel spasm, thrombosis, dissection (intimal disruption), or perforation. Throughout each case, Lightning provides procedural feedback via audiovisual cues. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Only use replacement fuse with correct rating (see Table 1 for fuse rating). 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-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. 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. The results may vary depending on a variety of patient specific attributes. 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 . 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. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus.
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