INDIGO Aspiration System Indication for Use 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. 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. Relying on a different mechanism of action, power aspiration with CAT RX and Penumbra ENGINE was able to extract the thrombus intact; thus restoring flow through the graft. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Distal emboli causing PDA occlusion after manual aspiration. suhail.dohad@cshs.org The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Figure 1. This is potentially more effective than diminished syringe-based aspiration. gtag('js', new Date()); Resterilization and/or reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Figure 3. Figure 2. 2015;372:1389-1398. We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. Figure 2. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . After IVUS, the stent was dilated to 3.75 mm. Disclosures: Consultant to Penumbra, Inc. A 92-year-old man with a history of coronary artery disease (treated previously with coronary artery bypass graft) and severe aortic stenosis (treated previously with transcatheter aortic valve replacement) presented to the ED with chest pain. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. 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. 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. Indication For Use Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. 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). Use only waterbased solvents for cleaning. Potential Adverse Events Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. Brandenton, Florida Do not use open or damaged packages. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 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 Initial angiography revealed an occlusion of the distal RCA. Suhail Dohad, MD, FACC A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The complaint indicated that the cat8 was kinked during the procedure. Vedantham S, Goldhaber SZ, Julian JA, et al. Jawairia Sahar K. Mirza, MBBS Copyright 2022 Penumbra, Inc. All rights reserved. function gtag(){dataLayer.push(arguments);} Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. 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. INDIGO Aspiration Catheters and Separators: To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Return all damaged devices and packaging to the manufacturer/distributor. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. The results may vary depending on a variety of patient specific attributes. Los Angeles, California The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. Penumbras IndigoAspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. In 2014, Penumbra broke into the peripheral thrombectomy space with the release of the first Indigo System catheters, the 5-F CAT5 catheter and the 3-F CAT3 catheter (Penumbra, Inc.). The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: The Swan-Ganz catheter was exchanged over a long V18 wire. Do not resterilize or reuse. Possible complications include, but are not limited to, the following: 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. 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. 510 (k) Number. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Smidt Heart institute Figure 2. Giri J, Sista AK, Weinberg J, et al. Worcester, Massachusetts Director of Cardiac & Peripheral Cath Lab Use prior to the Use By date. Return all damaged devices and packaging to the manufacturer/distributor. 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 procedure was completed with the same catheter. 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. Do not use kinked or damaged devices. o The Penumbra Indigo System Separator is intended for use with our Indigo System's family of catheters to enable the removal of a wide range of thrombus. Equipment is not safe for MR use. 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. 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. 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. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. 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. Penumbra's high-performance aspiration catheters. window.dataLayer = window.dataLayer || []; Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Contraindications There are no known contraindications. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. She was in a rehab facility prior to this new event recovering from her CVA. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. Precautions 1. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the PENUMBRA ENGINE as they can interfere with and result in degradation of the performance of the equipment. 0 cm from the hub. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 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. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Not for use in the coronaries or the neurovasculature. 3. Do not re-infuse blood or fluid from the canister back into the patient. Final angiogram showing resolution of extensive thrombus burden. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Warnings This is potentially more effective than diminished syringe-based aspiration. Figure 1. CAT7 and CAT12 are the next generation of the Indigo System catheters. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the Penumbra ENGINE as they can interfere with and result in degradation of the performance of the equipment. 0, 24. 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. These pages are not intended for patients or for members of the general public. UPC: Current Stock: . Do not use kinked or damaged devices. 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; Indication For Use 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. Disclosures: None. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Contraindications Contraindications There are no contraindications. Only use replacement fuse with correct rating (see Table 1 for fuse rating). For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. minimalism: a documentary about the important things transcript; cat8 penumbra catheter; i 75 road construction cincinnati; tocaya west hollywood; best places to live in alabama near the. 1. Prior to use, please consult device labeling and instructions for use. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. LIGHTNING Aspiration Tubing Indication for Use 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.