ADVANCED MATERIALS & PROCESSES | OCTOBER 2024 40 the pelvic veins, commonly afflicting women of childbearing years[8,9]. The highly compliant and soft nature of the SMP materials along with the high-volume, space-filling property of the materials make it an attractive solution compared to traditional permanent metallic coils, which have drawbacks such as imaging artifacts (CT and MRI), material rigidity, and remain permanently in the body. Preclinical testing has shown the SMP material to slowly bioabsorb over time while providing durable occlusion and rapid collagen conversion[10]. Additionally, the radiolucency of the material does not compromise future diagnostic imaging. FURTHER STUDIES Another application currently undergoing investigation is the use of IMPEDE-FX RapidFill in abdominal aortic aneurysms (AAA)[11-13] during endovascular aneurysm repair (EVAR) to improve the rate of aneurysm sac shrinkage in patients by completely filling the aneurysmal space with SMP. Recent research has shown the increased risk of mortality for patients with AAA that remain stable who have been treated with EVAR, thus the importance to reduce aneurysm size to improve patient outcomes[14]. Figure 5 shows the schematic summary of the clinical approach utilized at the time of the EVAR procedure to completely fill the aneurysmal space with SMP. A recent prospective multi-center single-arm pilot study was conducted where 34 patients were treated with SMP devices at the time of EVAR using the methods described in Fig. 5 to evaluate improving patient outcomes by increasing the rate of patients with shrinking AAA. Oneyear follow-up results showed that 81.8% of patients saw ≥10% decrease in normalized volume and 57.6% of patients achieved a ≥5 mm decrease in diameter, which are all greater than typically seen[12,13]. The promising outcomes of this early study have led to a recently approved FDA IDE randomized trial (AAA-SHAPE, Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion)[15] that will investigate EVAR plus sac management with IMPEDE-FX RapidFill (the treatment arm) against standard EVAR (the control arm) across 40 sites in the USA, Europe, and New Zealand. ~SMST Note: IMPEDE, IMPEDE-FX RapidFill, and TrelliX are registered trademarks of Shape Memory Medical Inc. Acknowledgments Shape Memory Medical Inc. is dedicated to developing innovative therapeutic solutions with its proprietary shape memory polymers. Neurovascular embolization products include the TrelliX Embolic Coil, which is CE marked for use in the EU. Peripheral embolization products include the IMPEDE and IMPEDE-FX Embolization Plugs and IMPEDE-FX RapidFill Device. In countries recognizing CE marking, the IMPEDE and IMPEDE-FX Embolization Plugs and the IMPEDE-FX RapidFill are indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. In the United States, the IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral Fig. 5 — 1) EVAR main body stent graft (a) is placed within the aneurysm while a guidewire (buddy wire) (b) is positioned (jailed) within the aneurysm for future catheter access. 2) After placing the contralateral limb (c), a sheath/catheter (d) is introduced over the buddy wire and jailed behind the limb (b) to allow access and deliver IMPEDE-FX RapidFill (e). 3) IMPEDE-FX RapidFill expands and fills the aneurysmal space (f). 4) IMPEDE-FX RapidFill facilitates stable thrombus formation. 7 FEATURE
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