CAT8XTORQ115KIT-NS. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Disclosures: Consultant to Penumbra, Inc. A 59-year-old man with a history of hypertension and tobacco use presented with an inferior-posterior acute myocardial infarction (MI). The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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 an oxygen rich environment. Control angiography immediately after thrombectomy demonstrated restored patency . Jawairia Sahar K. Mirza, MBBS The treatment of arterial and venous thrombus is challenging. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. The INDIGO SEPARATOR is not intended for use as a guidewire. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. 0, and 37. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. Flow through left circumflex artery post-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. Bradenton Cardiology Center/Manatee Memorial Hospital S. Jay Mathews, MD, MS, FACC The pulmonary capillary wedge pressure is 10 mmHg. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 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. 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. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. Contraindications There are no known contraindications. 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 Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Orange, California 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. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. The Indigo System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. Do not re-infuse blood or fluid from the canister back into the patient. 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. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. When performing aspiration, ensure that the INDIGO Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. 1. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. The cerebral 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. Final angiographic result of SVG. Possible complications include, but are not limited to, the following: PENUMBRA ENGINE Intended Use Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . 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. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. 0, 23. 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. Maintain a constant infusion of appropriate flush solution. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. Do not use kinked or damaged devices. INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 Indication for Use 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. 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. kolskiwellness@gmail.com Mechanical Thrombectomy. 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. Do not resterilize or reuse. 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. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Further evaluation of the returned device revealed kinks in the catheter shaft. 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. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. 2018;72:1589-1596. Director of Cardiac Catheterization Lab, PERT & Structural Heart 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. Jolly SS, Cairns JA, Lavi S, et al. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Do not position the Penumbra ENGINE so that it is difficult to remove the power cord. The Swan-Ganz catheter was exchanged over a long V18 wire. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. N Engl J Med. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Do not resterilize or reuse. 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. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Lightning comes packaged with the Indigo CAT7 or CAT12. 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. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . Distal emboli causing PDA occlusion after manual aspiration. 2019;140:e774-e801. N Engl J Med. The product-specific content of this website is intended for use by healthcare professionals only. Contraindications Not for use in the coronaries or the neurovasculature. System Chair, Clinical Research Categories. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Warnings/Precautions Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . There was partial improvement of flow, but total occlusion remained. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon 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 CAT family of catheters is the foundation of Penumbra's Indigo system. Copyright 2023 Penumbra, Inc. All rights reserved. 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 Otherwise, this could result in degradation of the performance of this equipment. Use prior to the Use By date. No modification of this equipment is allowed. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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. Waqas R. Qureshi, MD, MS It will reduce the service life of the PENUMBRA ENGINE. 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. Copyright 2022 Penumbra, Inc. All rights reserved. . Alameda, CA 94502. 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). Using the usual telescoping technique of the sheath, the CAT8 and SEP8 were used in tandem to aspirate the thrombus using sustained aspiration with Penumbra ENGINE. Penumbra ENGINE Indication For Use In our practice, we have been able to more accurately define percutaneous transluminal coronary angioplasty and stent length as a result of this increased visualization. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Tareq Kass-Hout. The Indigo Separator 4 is not intended for use as a guidewire. Mechanical power aspiration with a continuous vacuum source and large lumen aspiration catheter was first introduced in the neurovascular space when Penumbra revolutionized thrombus removal for acute ischemic stroke patients. Final angiogram confirming thrombus removal and restoration of flow to the pedal arch. CAT RX has allowed us to rethink how we approach these occluded SVGs. Do not use in an oxygen rich environment. These pages are not intended for patients or for members of the general public. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. The INDIGO Aspiration Tubing: Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. St. Joseph Hospital 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. Final angiogram showing resolution of extensive thrombus burden. Otherwise, this could result in degradation of the performance of this equipment. PENUMBRA ENGINE Indication for Use The following case reports highlight CAT RX in a multitude of unique applications as a primary frontline device to treat patients with high thrombus burden.
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