indigo system lightning 12

Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. All Rights Reserved Privacy Policy. July 14, 2020P enumbra, Inc. announced the United States commercial availability of the Indigo System Lightning 12, which is the company's next-generation aspiration system for peripheral thrombectomy.. Penumbra also announced appointments for two newly created positions: Corey L. Teigen, MD, as Chief Scientific Officer and James F. Benenati, MD, as Chief Medical Officer. University of Siena Access was gained through the groin using an 8-F Destination sheath (Terumo Interventional Systems). Immediately postprocedure, a decrease in PA pressure from 35 to 27 mm Hg was observed. Use prior to the Use By date. Utility of a power aspiration-based extraction technique as an initial and secondary approach in the treatment of peripheral arterial thromboembolism: results of the multicenter PRISM trial. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. Penumbra, Inc. The catheters, which were initially designed for intracranial navigation for the treatment of acute stroke, are provided with an atraumatic tip. Use prior to the Use By date. Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism . Stay informed on the week's top stories including literature summaries, device approvals, guideline changes, and more. Do not use in oxygen rich environment. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. 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. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. When in free-flowing blood, this technology automatically stops aspirating blood and hence limits unnecessary loss of blood. This website is intended for US audience only. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Contraindications There are no known contraindications. . The Indigo System Lightning 12 is the companys newest generation aspiration system for peripheral thrombectomy. Factors that could cause actual results to differ from those projected include, but are not limited to: the impact of the COVID-19 pandemic on our business, results of operations and financial condition; failure to sustain or grow profitability or generate positive cash flows; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base, expand our user base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; permanent write-downs or write-offs of our inventory; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; and potential adverse regulatory actions. The INDIAN registry is a prospective, multicenter registry designed to investigate, in a controlled setting, the safety and initial efficacy of the Indigo System in the treatment of acute peripheral arterial thromboembolism. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Venogram showing thrombosis of the left FV and CFV. The sustained aspiration from the Penumbra ENGINE provides constant uninterrupted full-vacuum aspiration throughout the procedure, addressing the constraints of syringe-based large-bore embolectomy, which include vacuum dropoff from the syringe filling with fluid. CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to . right-arrow To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Venogram showing CAT12 in the CIV. 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. Eur J Vasc Endovasc Surg. At Penumbra, I have a profound opportunity to change the course of healthcare delivery for people living with vascular disease. With the severity of this patients symptoms, immediate relief was required to maintain limb viability and the different profiles of the Indigo catheters provided a complete portfolio for aspiration in the arterial vasculature, starting with the CAT8 in the SFA and BTK to using the CAT RX coaxially in the heavily diseased TPT. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Henderson Hospital Engineered to be trackable, deliverable, and torqueable, the CAT8s atraumatic tip can navigate the lobar anatomy of the PA to help establish inflow and outflow, helping to restore patient vitals to normal. Director of Interventional Radiology Disclosures: Consultant to Penumbra, Inc. A 68-year-old man presented with a sudden coolness in both legs after stopping apixaban therapy for 3 days. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. It will reduce the service life of the PENUMBRA ENGINE. Good Samaritan Hospital Lightning 12 combines the new Indigo System CAT12 aspiration catheter with Lightning intelligent aspiration, enabling physicians to focus on optimising thrombus removal using the system's clot detection mechanism. The INDIGO SEPARATOR is not intended for use as a guidewire. Ballad Health System CVA Heart & Vascular Institute NYU Langone Health 2018;29:92-100. doi: 10.1016/j.jvir.2017.08.019. 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. Return all damaged devices and packaging to the manufacturer/ distributor. Do not resterilize or reuse. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Notably, Lightning 7 is designed . Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo System and Lightning 12 Intelligent Aspiration Tex Heart Inst J. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. The Indigo CAT12 represents an advancement in mechanical thrombectomy given its ability to aspirate large-volume thrombus in a single-session setting, which is especially beneficial in larger-lumen vascular beds, such as large-caliber veins as demonstrated in this case. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. The wire was removed, and the CAT8 was used to remove thrombus from the popliteal artery. The Lightning 12 addition to the Indigo Aspiration System is a formative development in the thrombectomy space. The Indigo System of catheters are trackable, deliverable, and can provide a nice treatment option for complex patients. This site is protected by reCAPTCHA and the Google, Mechanical clot engagement with proprietary Separator technology, Tip directionality for circumferential aspiration, The Indigo System is an integrated system for use only with other components of the Indigo System including the CAT family of catheters, Separators, Dynamic Aspiration Tubing, Lightning, Penumbra ENGINE, and Penumbra ENGINE Canister, Lightning Intelligent Aspiration comes packaged with CAT7, CAT8 or CAT12, Live feedback during the procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister. 2023 Bryn Mawr Communications II, LLC. Figure 7. Only use replacement fuse with correct rating (see Table 1 for fuse rating). MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW CAT3 advanced through the pedal loop (C). When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. . Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. Disclosures: None. Disclosures: Owns public stock in Penumbra; consultant and course director for Penumbra, Inc. A 77-year-old woman presented to the emergency department with a history of esophageal varices and bleeding, contraindicating her for tissue plasminogen activator (tPA). Veryan Medical Will Support Commercialization of Walk Vasculars Jeti Thrombectomy System in Germany, left-arrow PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. New York, New York The Next Generation of Thrombus Removal | Penumbra Inc Figure 8. Penumbra's Newest Generation of Indigo Aspiration System Receives FDA Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Precautions The device is intended or single use only. 5. Precautions The device is intended for single use only. Device Problem Adverse Event Without Identified Device or Use Problem (2993) The product was not returned for evaluation. Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism . From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event. Figure 2. PENUMBRA ENGINE Indication for Use Potential adverse . Indigo system with Lightning 7 and Lightning 12 launched in Europe Maintain a constant infusion of appropriate flush solution. Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Figure 3. Patrick E. Muck, MD, RVT, FACS Restored distal flow to the left TPT. Return all damaged devices and packaging to the manufacturer/ distributor. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. 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. The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE . Additional information about Penumbras products can be located on Penumbras website at http://www.penumbrainc.com/healthcare-professionals. (EXTRACT-PE). With a device time of only 5 minutes and no use of tPA, the patients symptoms were promptly relieved with no recurring episodes to date. Penumbra also announced appointments for two newly created positions: Corey L. Teigen, MD, as Chief Scientific Officer and James F. Benenati, MD, as Chief Medical Officer. Mean PA pressure at the start of the case was 35 mm Hg. Catheters & Separators. 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 right ventricular/left ventricular (RV/LV) ratio reduction of 27.3% at 48 hours. Figure 6. New York, New York Thomas S. Maldonado, MD ALAMEDA, Calif.--(BUSINESS WIRE)--Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the latest iteration of the Indigo Aspiration System, Lightning 12. INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use 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. Created with Sketch. Access was gained using an 8-F sheath in the left popliteal vein, which was then upsized to a 12-F sheath. With contributions from Edoardo Pasqui, MD; Carlo Setacci, MD; and Giancarlo Palasciano, MD, Surgical management of lower extremity acute limb ischemia (ALI) has been considered the preferred treatment for years. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Sista A. The major adverse event rate in EXTRACT-PE was 1.7%, and patients had a median intensive care unit stay of < 1 day. We gained access through the right CFV using a 14-F sheath. The patient, an active smoker, also had a history of pulmonary hypertension and hypercholesterolemia. The new Indigo System is engineered to allow for thrombectomy while helping to prevent excessive blood loss during the procedure. Disclosures: None. Individual results may vary depending on patient-specific attributes. 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.
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