Shape Memory Medical’s IMPEDE embolisation plug range has received CE mark as a Class III device under the European Union’s Medical Device Regulation (EU MDR).
The US company’s embolisation plugs are used to intentionally stop blood flow in a targeted artery or vein during vascular procedures. Impede and Impede-FX are porous embolic scaffolds that are crimped for catheter-based delivery and self-expand upon contact with blood. Meanwhile, Impede RapidFill is a cartridge that allows for five Impede-FX embolisation plugs to be introduced in a single application with the aim to quickly fill and occlude large vessels or lesions with reduced procedure and fluoroscopy time.
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According to Shape, the nature of Impede’s material allows for high-volume filling without exerting radial force, while its radiolucent properties aim to improve imaging clarity during procedures and follow-up assessments.
Shape Memory Medical’s CEO Ted Ruppel highlighted that the company’s EU MDR certification serves as testament to the strength of its clinical data.
Ruppel continued: “The IMPEDE Embolization Plug family’s clinical and real-world experience was central to the platform’s successful review.
“Achieving MDR certification ensures long-term access to Europe’s largest healthcare systems and reinforces physician confidence in the device family’s performance, consistency, and traceability.”
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By GlobalDataTo extend Impede’s clinical application beyond peripheral vascularisation, Shape is currently undertaking a pivotal trial (NCT06029660) of Impede-FX RapidFill. The study, called AAA-SHAPE, is evaluating the safety and effectiveness of RapidFill in abdominal aortic aneurysm sac healing and prevention of expansion when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment, according to an entry on Clinicaltrials.gov. Patients enrolled in the trial are those considered candidates for elective EVAR.
Shape also highlighted that it is preparing to initiate FLAGSHIP, a first-in-human study to evaluate a next generation, large-diameter shape memory polymer system that is specifically designed for false lumen embolisation in aortic dissection.
Impede gained US Food and Drug Administration (FDA) clearance in 2018. However, RapidFill is currently only cleared in the US as an investigational device. The embolisation plugs are also cleared in Japan.
