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. Initial angiography revealed an occlusion of the distal RCA. Cedars Sinai Medical Center This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 This is potentially more effective than diminished syringe-based aspiration. Penumbra's LANTERN Delivery Microcatheter integrates a highly trackable 2.6 F microcatheter with a high-flow lumen to facilitate confident delivery of Ruby Coil, POD, and Packing Coil even in tortuous anatomy. Copyright 2022 Penumbra, Inc. All rights reserved. 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. The complaint has been evaluated. Disclosures: None. 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. 1. 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 . Return all damaged devices and packaging to the manufacturer/distributor. Do not resterilize or reuse. 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. Lightning 12 and Lightning 8 expand the already broad offering of CAT8, CATD, CAT6, CAT5, and CAT3 and are paired with Penumbra ENGINE, the company's proprietary continuous, mechanical vacuum . Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . 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. Photo: Courtesy of Business Wire. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . N Engl J Med. Indigo System CAT RX tracking through the distal posterior tibial artery. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. 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. Do not use kinked or damaged devices. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. 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. Mathews SJ, Brown C, Kolski B, et al. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Penumbra, Inc. One Penumbra Place. 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 healthcare firm said that the Indigo CAT RX Aspiration Catheters . Penumbra's Indigo Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Learn more about Lightning. 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. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Applicant. Penumbras IndigoAspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. 3. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). This press release features multimedia. Do not use kinked or damaged devices. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. The Indigo System Catheter CAT8 was used across 22 sites in the United States in patients with submassive PE who did not receive thrombolytics (98.3%), with a . 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 newly available Indigo CAT12 Aspiration Catheter (Penumbra, Inc.) was utilized to perform mechanical thrombectomy of the FV, CFV, and EIV and CIV without the use of thrombolytics . Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. The newest indication for the Indigo System is the treatment of pulmonary embolism; this indication comes on the heels of the promising results of the EXTRACT-PE trial. 2015;372:1389-1398. CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. 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. 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. Figure 3. The CAT family of catheters is the foundation of Penumbra's Indigo system. Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. 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. Warnings To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Precautions Vascular Thrombectomy. Figure 2. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. Penumbra ENGINE Intended Use Possible complications include, but are not limited to, the following: 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 Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. There are no contraindications. Initial angiogram showing high thrombus burden in the RCA. Penumbra ENGINE Intended Use Use prior to the Use By date. If the cause cannot be determined, withdraw the device or system as a unit. System Chair, Clinical Research Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one each . Conclusions: evaluation of the cat8 revealed that the device was fractured. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Flow through left circumflex artery post-CAT RX. 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. K180412. 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. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. 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. Related Items. 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. To prevent fire or shock hazard, use a replacement power cord of equal rating. 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 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. Aspiration Tubing Intended Use INDIGO Aspiration Catheters and Separators: Contraindications Not for use in the coronaries or the neurovasculature. Indigo Separator 4 is intended to be used with Indigo CAT RX Aspiration Catheter to clear the distal end of the catheter lumen should it be blocked with thrombus. Mathews SJ, Brown C, Kolski B, et al. Use only waterbased solvents for cleaning. . This website is intended for US audience only. Do not reuse. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Ballad CVA Heart & Vascular Institute She was in a rehab facility prior to this new event recovering from her CVA. If repositioning of the INDIGO CAT RX Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard guidewire techniques. gtag('js', new Date()); Distal OD, Sterile, Single-Use, Disposable, For CAT8 Penumbra Devices, Indigo Aspiration Catheters, Removal of Fresh, Soft Emboli and Thrombi from Vessels of Peripheral Arterial and Venous Systems Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 0, 24. Learn more about Lightning. 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. Return all damaged devices and packaging to the manufacturer/ distributor. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Within 72 hours, repeat echocardiography showed RV/LV ratio improvement from 1.43 to 0.98. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. 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. J Vasc Interv Radiol. Figure 1. Maintain a constant infusion of appropriate flush solution. Do not use kinked or damaged devices. Do not use open or damaged packages. 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). Do not resterilize or reuse. We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus.

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