Shape Memory Medical Inc., the innovator of shape memory polymer for endovascular applications, announced the completion of patient enrollment in the EMBO Post Market Surveillance (EMBO-PMS) Registry, the Company's prospective, multicenter registry of the IMPEDE and IMPEDE-FX Embolization Plugs, and IMPEDE-FX RapidFill Device when used for peripheral vascular embolization.
"Reaching this milestone in our clinical program marks a significant step forward," said Ted Ruppel, President and Chief Executive Officer of Shape Memory Medical. "We are deeply grateful to the patients, investigators, and clinical study teams whose dedication made this achievement possible. We now look ahead with anticipation to the follow-up data and the insights it will yield." The EMBO-PMS Registry enrolled 110 patients across ten centers in the United Kingdom and Germany and will follow participants for 12 months to assess outcomes and device performance over time.
The IMPEDE Embolization 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.
EMBO-PMS represents the first prospective, multicenter study designed to systematically evaluate the real-world application of the novel shape memory polymer devices in peripheral vascular embolization procedures. The study encompasses a diverse spectrum of arterial and venous applications, including visceral aneurysms, pre-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.
"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," said Robert Morgan, FRCR, EBIR-ES, principal investigator for EMBO-PMS UK and Professor of Interventional Radiology at St. George's University Hospitals Foundation NHS Trust and St. George's, University of London. "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."
Götz Martin Richter, MD, PhD, principal investigator for EMBO-PMS Germany and Chairman of the Clinic for Diagnostic and Interventional Radiology at Klinikum Stuttgart in Stuttgart, Germany 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 one-year follow-up data, which will provide important insight into the durability of the embolotherapy."
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 embolization. A retrospective review of long-term follow-up imaging demonstrated no evidence of recanalization, underscoring the device's durable embolic performance (Holden A, et al. Vascular. 2024 Oct;32(5):1137-1142).
The latest EMBO-PMS results have been accepted for presentation at the CIRSE Annual Congress, September 13-17, in Barcelona, Spain.
Shape Memory Medical is studying new clinical applications and has initiated AAA-SHAPE Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion, a prospective, multicenter, randomized, open-label trial to determine the safety and effectiveness of the IMPEDE-FX RapidFill® Device to improve abdominal aortic aneurysm (AAA) sac behavior, when used with elective endovascular aneurysm repair (EVAR). Enrollment will continue through 2025. The company is also planning to evaluate an innovative, large-diameter shape memory polymer system designed for false lumen embolization in aortic dissection.
About Shape Memory Medical
Shape Memory Medical Inc. is a California-based, global medical device company dedicated to developing innovative therapeutic solutions with its proprietary shape memory polymers, with devices approved in more than 30 countries spanning regions in Asia, the Middle East, Europe, the Americas and Australia. The IMPEDE and IMPEDE-FX Embolization Plugs and IMPEDE-FX RapidFill are CE Mark approved. The IMPEDE and IMPEDE-FX Embolization Plugs are approved in Japan and cleared for use in the United States. In the United States, the IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral 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. 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.
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Contacts:
Maryanne Koller
m.koller@shapemem.com
+1 408 649 5175
