Shape Memory Medical today announced the completion of patient enrollment in the EMBO postmarket surveillance (EMBO-PMS) registry, the company’s prospective, multicenter registry of the Impede and Impede-FX embolisation plugs, and Impede-FX RapidFill device when used for peripheral vascular embolization.
A press release details that the Impede embolisation plug family of devices utilizes Shape Memory Medical’s proprietary shape memory polymer—a porous, radiolucent embolic material that is crimped for catheter delivery and self-expands to its original shape upon exposure to the warm, aqueous environment of a blood vessel. “This expansion creates a conformable, porous scaffold that supports stable thrombus formation and rapid occlusion throughout its structure,” the release reads.
According to Shape Memory Medical, EMBO-PMS represents the first prospective, multicentre study designed to systematically evaluate the real-world application of the novel shape memory polymer devices in peripheral vascular embolisation procedures. The study encompasses a diverse spectrum of arterial and venous applications, including visceral aneurysms, pre-endovascular aneurysm repair (EVAR) branch vessel occlusion, pelvic venous disorders, and vascular anomalies. To date, sustained occlusion has been observed at early follow-up, with no serious adverse events related to the study devices. One-year outcomes are anticipated next year.
Shape Memory Medical notes that, before the launch of the EMBO-PMS study, the Impede embolization plug underwent initial evaluation in a first-in-human, prospective, single-arm safety study involving 10 patients who underwent peripheral vascular embolisation, and a retrospective review of long-term follow-up imaging demonstrated no evidence of recanalization. The company advises that the latest EMBO-PMS results have been accepted for presentation at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress 2025 (Sept. 13–17) in Barcelona, Spain.
