Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . sjaymathewsmd@gmail.com PENUMBRA ENGINE Intended Use The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. Initial angiogram of the right pulmonary artery showing pulmonary embolism. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 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. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. 0, and 37. Do not resterilize or reuse. The complaint has been evaluated. 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. Penumbra, Inc. One Penumbra Place. Potential Adverse Events 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. 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. The CAT family of catheters is the foundation of Penumbra's Indigo System. Bradenton Cardiology Center/Manatee Memorial Hospital 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 Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System.The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Sista A. Indigo aspiration system for acute pulmonary embolism. 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; and Suhail Dohad, MD, FACC. Do not resterilize or reuse. The Penumbra Indigo System Separator is intended for use with our Indigo Systems CAT family of catheters to enable the removal of a wide range of thrombus. Because the patient was not a candidate for thrombolysis, the decision was made to intervene with the Indigo System CAT8XTORQ115 and SEP 8, which were advanced sequentially into the right then left pulmonary artery. Jawairia Sahar K. Mirza, MBBS Do not resterilize or reuse. Separator 8, 150 cm Length, 0.072 in. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. 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. 3. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. Neuro | Penumbra, Inc. | Mechanical Thrombectomy & Embolization 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 . Return all damaged devices and packaging to the manufacturer/distributor. (CAT3, CAT RX, CAT5, CAT6, CAT8, and CATD) and patented Separator technology, which maintains continuous aspiration and helps limit clogging of the catheters tip during the procedure. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. 2018;72:1589-1596. Flow through left circumflex artery post-CAT RX. 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. Final angiographic result of SVG. Maintain a constant infusion of appropriate flush solution. To prevent fire or shock hazard, use a replacement power cord of equal rating. Penumbra Indigo System | Vascular Thrombectomy Randomized trial of primary PCI with or without routine manual thrombectomy. INDIGO Aspiration System Intended Use Copyright 2023 Penumbra, Inc. All rights reserved. PENUMBRA: CAT6 - WestCMR University of Massachusetts Medical School Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The INDIGO SEPARATOR is not intended for use as a guidewire. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. PENUMBRA ENGINE Indication for Use Do not re-infuse blood or fluid from the canister back into the patient. Warnings 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 use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. An Interview With Binita Shah, MD, MS, FACC, FSCAI, By Mansi Oberoi, MD; M. Chadi Alraies, MD; and Poonam Velagapudi, MD, MS, Left Main Disease and Bifurcation Revascularization in Female Patients, By Tara L. Jones, MD, PharmD, and Valeria Paradies, MD, By Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, Applying Team-Based Care Delivery to Interventional Cardiology: Learnings from the 2022 MedAxiom CV APP Survey, Understanding Sex Differences in Acute and Chronic Coronary Syndromes, By F. Aaysha Cader, MBBS, MD, MRCP(UK), MSc(Oxon); Rudaynah Amein Alali, MBBS, Internal Medicine Board, Interventional Cardiology Fellowship, RCPI; and Mirvat Alasnag, MD, FACP, FACC, FSCAI, FSCCT, SuperSaturated Oxygen Therapy: Cases and Cocktails Event Winning Presentations, With Charishma Nallapati, MD; Amer N. Kadri, MD; James Richard Spears, MD; Zaid Al-Jebaje, MD; Babar Basir, DO; and Khaldoon Alaswad, MD, FACC, FSCAI. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. 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. Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. Ultrasound-guided access was obtained through the right femoral vein. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. 22. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. Interventional Cardiology Smidt Heart institute Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). Use only waterbased solvents for cleaning. 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. Director of Cardiac Catheterization Lab, PERT & Structural Heart Do not use open or damaged packages. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. St. Joseph Hospital Potential Adverse Events No modification of this equipment is allowed. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. 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. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Otherwise, this could result in degradation of the performance of this equipment. There are no 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. Do not resterilize or reuse. 0, 26. window.dataLayer = window.dataLayer || []; The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). The product-specific content of this website is intended for use by healthcare professionals only. The cat8 was kinked approximately 69. Penumbra Cat 8 - IndiaMART Return all damaged devices and packaging to the manufacturer/distributor. Penumbra Announces U.S. Commercial Availability of INDIGO System We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. Tareq Kass-Hout. 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. 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. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Vedantham S, Goldhaber SZ, Julian JA, et al. 5, 19. The patient received a 3.5- X 38-mm everolimus-eluting stent (Synergy drug-eluting stent [DES], Boston Scientific Corporation) with postdilation optimized by intravascular ultrasound (IVUS) and was then sent to the step-down unit. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm.