We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. Photo: Courtesy of Business Wire. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. window.dataLayer = window.dataLayer || []; The device is intended for single use only. Disclosures: None. Penumbra, CAT8TORQ85, Penumbra CAT8 Indigo Aspiration Catheter, Torq Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Device Name. The results may vary depending on a variety of patient specific attributes. Created with Sketch. 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. Los Angeles, California 5, 19. Contraindications Interventional Cardiology The INDIGO Aspiration Tubing is intended to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. 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. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Next Article chronic clot, atherosclerotic plaque) The cerebral vasculature Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. Saint Louis, Missouri The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. Throughout each case, Lightning provides procedural feedback via audio visual cues. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. Additional Details. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). The patient had a medical history of cyclical vomiting, hypertension, diabetes, and hyperlipidemia. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. 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. 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). function gtag(){dataLayer.push(arguments);} Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Mechanical thrombectomy was performed. Precautions Prior to use, please consult device labeling and instructions for use. gtag('js', new Date()); The CAT family of catheters is the foundation of Penumbra's Indigo system. Possible complications include, but are not limited to, the following: Penumbra, CAT8XTORQ115, Penumbra CAT8 Indigo Aspiration Catheter, XTorq The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. This website is intended for US audience only. Missouri Baptist Medical Center Figure 3. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. 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). Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. The means of mains disconnect is to remove the power cord. INDIGO Aspiration System Intended Use Figure 2. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Use prior to the Use By date. Ultrasound-guided access was obtained through the right femoral vein. 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. 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. This is potentially more effective than diminished syringe-based aspiration. 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. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Do not use kinked or damaged devices. Director, Structural Heart . 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. 510(k) Premarket Notification - Food And Drug Administration To prevent fire or shock hazard, use a replacement power cord of equal rating. University of Massachusetts Medical School 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. Indication For Use Penumbra ENGINE Indication For Use Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Penumbra, CAT8STR85, Penumbra CAT8 Indigo Aspiration Catheter, Straight Distal posterior tibial artery emboli occlusion. 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. 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 of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. 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 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. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 (Penumbra, Inc.) are indicated for the removal of fresh soft emboli and thrombi from vessels in the coronary and peripheral vasculature. 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. 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. 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 . The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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. 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. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography.
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