Only use replacement fuse with correct rating (see Table 1 for fuse rating). gtag('js', new Date()); Do not use kinked or damaged devices. Precautions The device is intended or single use only. Equipment is not safe for MR use. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. INDIGO Aspiration Tubing: The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. 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. 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. CAT7 and CAT12 are the next generation of the Indigo System Catheters. The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. 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. If the cause cannot be determined, withdraw the device or system as a unit. TIMI 3 flow was achieved in 88% of cases. Do not use kinked or damaged devices. Conclusions: evaluation of the cat8 revealed that the device was fractured. Use prior to the Use By date. 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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. Potential Adverse Events 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. If the cause cannot be determined, withdraw the device or system as a unit. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. 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. 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). Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. 2: Add Precautions The device is intended for single use only. The INDIGO SEPARATOR is not intended for use as a guidewire. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. 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. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Order Qty. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. All Rights Reserved Privacy Policy, With S. Jay Mathews, MD, MS, FACC; Chris Metzger, MD; Waqas R. Qureshi, MD, MS; Jawairia Sahar K. Mirza, MBBS; Gus Theodos, MD, FACC, FSCAI; Brian Kolski, MD; Suhail Dohad, MD, FACC. 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. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). 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. 5, 19. The low-profile catheter and Penumbra ENGINE are easy to set up and use. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Do not use in an oxygen rich environment. Director of Cardiac & Peripheral Cath Lab This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. 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/fibrillation; arteriovenous fistula; death; device malfunction; distal embolization; emergent surgery; false aneurysm formation; hematoma, hemorrhage, or blood loss at access site; hematoma, hemorrhage, or blood loss; hypotension; inability to completely remove thrombus or control blood flow; infection; ischemia; kidney damage from contrast media; myocardial infarction; neurological deficits including stroke; respiratory failure; thromboembolic events; vascular complications (including vessel spasm, thrombosis, intimal disruption, dissection, or perforation). indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. 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. Penumbra Aspiration Pump: Potential Adverse Events 1. This website is intended for US audience only. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Distal emboli causing PDA occlusion after manual aspiration. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon left-arrow Brandenton, Florida 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. Potential Adverse Events The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. 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. Copyright 2022 Penumbra, Inc. All rights reserved. J Am Coll Cardiol. CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral . We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. 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. It will reduce the service life of the PENUMBRA ENGINE. Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. BJC Cardiology After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. Saxon RR, Benenati JF, Teigen C, et al. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. Available in a selection of sizes, the CAT family can provide access to distal peripheral . The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. Penumbra ENGINE Intended Use Cedars Sinai Medical Center Ballad CVA Heart & Vascular Institute Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. . 1. N Engl J Med. Warnings/Precautions INDIGO System LIGHTNING Aspiration Tubing Intended Use If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. Final angiogram showing resolution of extensive thrombus burden. Contraindications There are no contraindications. The product-specific content of this website is intended for use by healthcare professionals only. Control angiography immediately after thrombectomy demonstrated restored patency . 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. 510 (k) Number. INDIGO Aspiration System Intended Use Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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 use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Photo: Courtesy of Business Wire. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. The CAT familyof catheters is the foundation of Penumbras Indigo System. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . No modification of this equipment is allowed. Launches Indigo System Lightning 12 in U.S. Appoints Corey L. Teigen, M.D., as Chief Scientific Officer and James F. Benenati, M.D., FSIR, as Chief Medical Officer Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced its next phase for vascular franchise growth with U.S. commercial availability of the Indigo System Lightning 12 and . Copyright 2022 Penumbra, Inc. All rights reserved. N Engl J Med. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. Penumbra's high-performance aspiration catheters. Do not resterilize or reuse. If the cause cannot be determined, withdraw the device or system as a unit. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 0 cm from the distal tip. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . 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. This content is not intended to offer professional medical advice. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Randomized trial of primary PCI with or without routine manual thrombectomy. chronic clot, atherosclerotic plaque) 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 PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. 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. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. Initial angiogram showing high thrombus burden in the RCA. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . 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 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. Maintain a constant infusion of appropriate flush solution. She was in a rehab facility prior to this new event recovering from her CVA. Do not use open or damaged packages. Manual aspiration using a Pronto V3 (Teleflex) catheter restored some flow, however, distal embolization to the posterior descending artery (PDA) immediately caused right ventricular cardiac arrest (Figure 2). Waqas R. Qureshi, MD, MS INDIGO Aspiration Catheters and Separators: 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. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Penumbras Indigo Aspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism and/or certain central circulatory system conditions such as pulmonary emboli. Throughout each case, Lightning provides procedural feedback via audio visual cues. Jolly SS, Cairns JA, Yusuf S, et al. The means of mains disconnect is to remove the power cord. Her heart rate was 110 beats per minute, elevated troponin levels at 4.5 ng/mL, and elevated brain natriuretic peptide at 1,164 pg/mL. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. 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. St. Joseph Hospital At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. The Indigo System utilises the Penumbra ENGINE aspiration 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. Throughout each case, Lightning provides procedural feedback via audiovisual cues. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. 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. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. It will reduce service life of the Penumbra ENGINE. 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. Alameda, CA 94502. The procedure was completed with the same catheter. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. 2. Brian Kolski, MD Ultrasound-guided access was obtained through the right femoral vein. 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 system uses Penumbra's RED reperfusion catheters. window.dataLayer = window.dataLayer || []; After one pass with mechanical thrombectomy using CAT RX, the thrombus was removed and flow was restored to the pedal arch via the plantar posterior tibial artery (Figure 2 and Figure 3). Pela bainha, foi introduzido o dispositivo de aspirao Penumbra Indigo System CAT8 XTORQ (Penumbra Inc., Alameda, Califrnia, Estados Unidos) em trombo segmentar, lobar ou arterial pulmonar principal, sendo realizada aspirao contnua (Figuras 2 e 3).