ADVANCED MATERIALS & PROCESSES | OCTOBER 2024 41 8 vasculature, and the IMPEDE-FX Embolization Plug is indicated for use with the IMPEDE Embolization Plug to obstruct or reduce the rate of blood flow in the peripheral vasculature. The IMPEDE and IMPEDE-FX Embolization Plugs are PMDA approved in Japan. The TrelliX Embolic Coil and IMPEDE-FX RapidFill Device are not available in the United States or Japan. In the United States, IMPEDE-FX RapidFill is an investigational device, limited by Federal (or United States) law to investigational use. For more information, visit www.shapemem.com. For more information: Sayyeda Marziya Hasan, senior manager, Shape Memory Medical Inc., 1321 Ridder Park Drive, Suite 10, San Jose, CA, 95131, marziya@shapemem.com, www.shapemem.com. References 1. S.M. Hasan, L.D. Nash, and D.J. Maitland, Porous Shape Memory Polymers: Design and Applications. J. Polym. Sci. Part B: Polym. Phys., 54(14), p 1300-1318, Jan 2016, doi.org/ 10.1002/polb.23982, Epub Jan 2016. 2. T.L. Landsman, et al., Design and Verification of a Shape Memory Polymer Peripheral Occlusion Device, J Mech Behav Biomed Mater, 63, p 195-206, October 2016, doi. org/10.1016/j.jmbbm.2016.06.019, Epub Jun 23, 2016, PMID: 27419615, PMCID: PMC5508979. 3. S.M. Hasan, et al., Effects of Isophorone Diisocyanate on the Thermal and Mechanical Properties of Shape-Memory Polyurethane Foams, Macromol Chem Phys, 215(24), p 24202429, Dec 2014, doi.org/10.1002/macp.201400407, Epub Oct 30, 2014, PMID: 30220825, PMCID: PMC6136255. 4. S.M. Hasan, et al., Tungsten-loaded SMP Foam Nanocomposites with Inherent Radiopacity and Tunable Thermo- mechanical Properties, Polym Adv Technol, 27(2), p 195-203, Feb 2016, doi.org/10.1002/pat.3621, Epub Aug 11, 2015, PMID: 30034202, PMCID: PMC6052881. 5. L.D. Nash, et al., Increased X-ray Visualization of Shape Memory Polymer Foams by Chemical Incorporation of Iodine Motifs, Polymers (Basel), 9(8), p 381, 2017, doi.org/10.3390/ polym9080381, Epub Aug 20, 2017, PMID: 30034862, PMCID: PMC6052870. 6. R.A. Morgan, et al., Clinical Experience with a Shape Memory Polymer Peripheral Vascular Embolisation Plug: A Case Series, CVIR Endovasc, 4(1):29, Mar 9, 2021, doi.org/10.1186/ s42155-021-00214-w, PMID: 33687582, PMCID: PMC7943681. 7. A. Holden, A.A. Hill, and B.T. Buckley, Shape Memory Polymer Technology in Peripheral Vascular Embolization, Vascular, May 22, 2023, doi.org/10.1177/17085381231177851, Epub ahead of print, PMID: 37218283. 8. D. Castellano, et al., Shape Memory Polymer Ovarian Vein Embolisation in a Patient with Nickel Allergy, CVIR Endovasc., 4(1):25, Mar 2, 2021, doi.org/10.1186/s42155-02100212-y, PMID: 33655366, PMCID: PMC7925783. 9. J.I. Leal Lorenzo, et al., Early Experience on Embolisation of Female Pelvic Venous Disease with a Single Shape Memory Vascular Plug: A Prospective Magnetic Resonance Imaging Based Evaluation, Eur J Vasc Endovasc Surg, 67(6), p 10171018, Jun 2024, doi.org/10.1016/j.ejvs.2024.03.015, Epub Mar 16, 2024, PMID: 38499144. 10. S.L. Jessen, et al., Microscopic Assessment of Healing and Effectiveness of a Foam-based Peripheral Occlusion Device, ACS Biomater Sci Eng, 6(5), p 2588-2599, May 11, 2020, doi.org/10.1021/acsbiomaterials.9b00895, Epub Sep 23, 2019, PMID: 32715083, PMCID: PMC7380656. 11. A. Massmann, et al., Feasibility of Aortic Aneurysm Sac Embolization using a Novel Shape Memory Polymer Embolic Device, Eur Radiol Exp, 7(1):12, Apr 3, 2023, doi.org/10.1186/ s41747-023-00328-x, PMID: 37009937, PMCID: PMC10068687. 12. A. Holden, et al., Active Aortic Aneurysm Sac Treatment with Shape Memory Polymer during Endovascular Aneurysm Repair, J Vasc Surg Cases Innov Tech, 9(3), p 101241, Jun 12, 2023, doi.org/10.1016/j.jvscit.2023.101241, PMID: 37496654, PMCID: PMC10366578. 13. A. Holden, et al., One-year Follow-up after Active Aortic Aneurysm Sac Treatment with Shape Memory Polymer Devices during Endovascular Aneurysm Repair, J Vasc Surg, 79(5), p 1090-1100.e4, May 2024, doi.org/10.1016/j.jvs. 2023.12.045, Epub Jan 5, 2024, PMID: 38185214. 14. T.F.X. O’Donnell, et al., Aneurysm Sac Failure to Regress after Endovascular Aneurysm Repair is Associated with Lower Long-term Survival, J Vasc Surg, 2019, 69(2), p 414-422. 15. Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion (AAA-SHAPE Pivotal Trial). ClinicalTrials.gov identifier: NCT06029660. Updated July 17, 2024. Accessed August 7, 2024. FEATURE
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