First European Patient Enrolled in AAA-SHAPE Pivotal Trial Testing Novel Aneurysm Treatment
• Shape Memory Medical has announced the first European enrollment in their AAA-SHAPE pivotal trial, evaluating the IMPEDE-FX RapidFill device for improving abdominal aortic aneurysm outcomes during endovascular repair.
• The multicenter, randomized trial will enroll 180 patients across 50 sites globally, with key endpoints measuring aneurysm sac changes, endoleak rates, and secondary interventions.
• Research indicates 60% of aneurysms fail to regress or continue expanding after standard EVAR procedures, highlighting the significant unmet need this novel shape memory polymer technology aims to address.
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