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September 8, 2025
EMBO-PMS Registry of Shape Memory’s Impede Vascular Embolization Devices Completes Enrollment
September 8, 2025—Shape Memory Medical Inc., a developer of shape memory polymer for endovascular applications, announced the completion of patient enrollment in the EMBO Post Market Surveillance Registry (EMBO-PMS).
Additionally, the company advised that the latest EMBO-PMS results have been accepted for presentation at the CIRSE annual congress held September 13-17 in Barcelona, Spain.
According to Shape Memory Medical, the prospective, multicenter EMBO-PMS registry is evaluating the company’s Impede and Impede-FX embolization plugs and the Impede-FX RapidFill device when used for peripheral vascular embolization.
The registry enrolled 110 patients across 10 centers in the United Kingdom and Germany and will follow patients for 12 months to assess outcomes and device performance over time.
The company noted that the study encompasses a diverse spectrum of arterial and venous applications, including visceral aneurysms; pre-endovascular aneurysm repair 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. The 1-year outcomes are anticipated in 2026.
Robert Morgan, FRCR, EBIR-ES, and Götz Martin Richter, MD, PhD, serve as Principal Investigators for EMBO-PMS United Kingdom and EMBO-PMS Germany, respectively.
“Metallic embolization coils and plugs have long been effective tools, but their use can be limited by imaging interference and artifact on follow-up CT scans,” commented Dr. Morgan in the company’s press release. “The radiolucency of shape memory polymer presents a promising advantage by enhancing visualization of surrounding anatomy during the procedure and improving clarity in follow-up imaging.”
Dr. Richter added, “It’s been highly encouraging to see the broad utility of the Impede devices across multiple endovascular applications. We’re eager to see the 1-year follow-up data, which will provide important insight into the durability of the embolotherapy.”
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