14 Vizient Tech Watch | Medical Device | Volume 2, 2024 Technology spotlight Penumbra’s Lightning Flash technology represents a fundamental change in how blood clots are removed from the body, including peripheral venous thrombus and PE. Cleared by the U.S. FDA in December 2022, the Lightning Flash system is designed to improve speed, safety and simplicity of intervention. The Lightning technology has been recognized as an innovative technology by the Centers for Medicare & Medicaid Services. It was given a unique ICD-PCS code for the technology: Extirpation of Matter using Computeraided Mechanical Aspiration. Source: 2024 Penumbra. All rights reserved. Used with permission of Penumbra. 1 Turetz M, Sideris AT, Friedman OA, et al. Epidemiology, Pathophysiology, and Natural History of Pulmonary Embolism. Semin Intervent Radiol. 2018 Jun;35(2):92-98. doi: 10.1055/s-0038-1642036. Epub 2018 Jun 4. PMID: 29872243; PMCID: PMC5986574. 2 Al-Hameed FM. Venous thromboembolism prophylaxis: Solutions are in our hands. Ann Thorac Med. 2011 Jul;6(3):105-6. doi: 10.4103/1817-1737.82434. PMID: 21760838; PMCID: PMC3131749. 3 Loffredo, L., Vidili, G., Sciacqua, A. et al. Asymptomatic and symptomatic deep venous thrombosis in hospitalized acutely ill medical patients: risk factors and therapeutic implications. Thrombosis J. 20, 72 (2022). https://doi.org/10.1186/s12959-022-00433-8 4 Klok FA, van der Hulle T, den Exter PL, Lankeit M, Huisman MV, Konstantinides S. The post-PE syndrome: a new concept for chronic complications of pulmonary embolism. Blood Rev. 2014 Nov;28(6):221-6. doi: 10.1016/j.blre.2014.07.003. Epub 2014 Aug 15. PMID: 25168205. 5 Kahn S, Mathes B. Post-thrombotic (postphlebitic) syndrome in adults. UpToDate. Published Feb. 28, 2024. Accessed on Sept. 9, 2024. Post-thrombotic (postphlebitic) syndrome in adults - UpToDate 6 Bryce YC, Perez-Johnston R, Bryce EB, Homayoon B, et al. Pathophysiology of right ventricular failure in acute pulmonary embolism and chronic thromboembolic pulmonary hypertension: a pictorial essay for the interventional radiologist. Insights Imaging. 2019 Feb 13;10(1):18. doi: 10.1186/s13244-019-0695-9. PMID: 30758687; PMCID: PMC6375098. 7 Chatterjee S, Chakraborty A, Weinberg I, Kadakia M, Wilensky RL, Sardar P, Kumbhani DJ, Mukherjee D, Jaff MR, Giri J. Thrombolysis for pulmonary embolism and risk of all-cause mortality, major bleeding, and intracranial hemorrhage: a meta-analysis. JAMA. 2014 Jun 18;311(23):2414-21. doi: 10.1001/jama.2014.5990. PMID: 24938564. 8 Sista AK, Horowitz JM, Tapson VF, Rosenberg M, Elder MD, Schiro BJ, Dohad S, Amoroso NE, Dexter DJ, Loh CT, Leung DA, Bieneman BK, Perkowski PE, Chuang ML, Benenati JF; EXTRACT-PE Investigators. Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial. JACC Cardiovasc Interv. 2021 Feb 8;14(3):319-329. doi: 10.1016/j.jcin.2020.09.053. Epub 2021 Jan 13. PMID: 33454291. 9 Avgerinos ED, Mohapatra A, Rivera-Lebron B, Toma C, Kabrhel C, Fish L, Lacomis J, Ocak I, Chaer RA; PERT Consortium. Design and rationale of a randomized trial comparing standard versus ultrasound-assisted thrombolysis for submassive pulmonary embolism. J Vasc Surg Venous Lymphat Disord. 2018 Jan;6(1):126-132. doi: 10.1016/j.jvsv.2017.09.004. PMID: 29248101; PMCID: PMC6394224. 10 Yu Q, Badar W, Patel M, et al. Percutaneous Thrombectomy using a Computer Assisted Aspiration Device for Deep Vein Thrombosis, Journal of Vascular and Interventional Radiology (2024), doi: https://doi.org/10.1016/j.jvir.2024.08.023 11 Comparison of two pulmonary embolism treatments. ClinicalTrials.gov. Published July 18, 2024. Accessed Sept. 20, 2024. Study Details | Comparison of Two Pulmonary Embolism Treatments | ClinicalTrials.gov 12 Study of the long-term patient safety and outcomes of treating pulmonary embolism with the Indigo Aspiration System. ClinicalTrials.gov. Published April 1, 2024. Accessed Sept. 20, 2024. https://clinicaltrials.gov/study/NCT04798261 13 Vizient, Inc. Vizient Clinical Data Base. Accessed Sept. 20, 2023. Clinical Database | Healthcare Database Records (vizientinc.com) References
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