Shape Memory Medical wins EU MDR Class III certification for IMPEDE embolization devices

Shape Memory Medical Inc. said its IMPEDE Embolization Plug product family has received certification as a Class III device under the European Union’s Medical Device Regulation, clearing a higher regulatory bar and securing continued access to European markets well ahead of looming deadlines.

The IMPEDE devices had previously been CE-marked under the older Medical Device Directive, but the EU’s MDR 2017/745 imposes more stringent requirements for clinical evidence, post-market surveillance, and risk management. Certification under the MDR is required by 2027 for Class IIb implantable and Class III devices.

“Securing MDR CE Mark certification for the IMPEDE platform is a major milestone in our commitment to advancing breakthrough therapies for endovascular disease,” said Ted Ruppel, president and CEO of Shape Memory Medical. “It recognizes both the strength of our clinical data and the dedication of our global clinical partners.”

Ruppel said the review process placed heavy emphasis on real-world performance. “The IMPEDE Embolization Plug family’s clinical and real-world experience was central to the platform’s successful review,” he said. “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.”

The IMPEDE Embolization Plug family includes the IMPEDE Embolization Plug, IMPEDE-FX Embolization Plug, and IMPEDE-FX RapidFill. The devices use a shape memory polymer designed to promote vessel thrombosis. The porous material is crimped for catheter-based delivery and self-expands on contact with blood, allowing rapid occlusion without exerting radial force on vessel walls. The soft, conformable scaffold is radiolucent, which can improve visualization during procedures and follow-up imaging.

Beyond its peripheral vascular indications, the company is advancing additional uses through the AAA-SHAPE trial, a prospective, multicenter, randomized study evaluating whether the IMPEDE-FX RapidFill device can improve abdominal aortic aneurysm sac behavior when used alongside endovascular aneurysm repair. The study is expected to enroll up to 180 patients, with follow-up extending to five years, and enrollment anticipated to conclude in 2026. The company is also preparing a first-in-human study of a next-generation system aimed at treating false lumens in aortic dissection.

Advances in endovascular embolization

The certification comes amid rapid evolution in endovascular embolization, a field increasingly focused on improving precision, durability, and long-term outcomes while reducing procedural complexity. Traditional embolization methods, such as metallic coils and liquid embolics, have long been effective but can present trade-offs related to imaging artifacts, inflammation, or challenges achieving complete occlusion in large or irregular spaces.

In recent years, researchers and clinicians have emphasized biomaterials that better mimic natural healing processes. Porous scaffolds and bioresponsive materials are being engineered to encourage organized clot formation and tissue integration, rather than simply blocking blood flow. This approach aims to reduce the risk of recanalization and late complications, particularly in complex anatomies such as aneurysm sacs or dissected vessels.

Another area of progress has been imaging compatibility. As follow-up surveillance becomes more important—especially under stricter regulatory frameworks—devices that minimize artifact on CT and MRI scans are gaining attention. Clearer imaging can improve clinicians’ ability to assess healing, detect endoleaks, and make informed decisions about reintervention without ambiguity caused by device-related distortion.

Regulatory changes in Europe have also reshaped development strategies across the sector. The MDR’s heightened demands for clinical data and post-market evidence have pushed manufacturers to invest earlier in robust trials, long-term follow-up, and real-world registries. While the transition has been challenging, many clinicians see it as reinforcing confidence in newer technologies entering routine practice.

At the same time, embolization is expanding beyond peripheral vessels into more complex aortic and structural heart applications. Investigators are exploring how embolic materials can be used adjunctively with established endovascular repairs to improve durability and prevent disease progression over years, not just months. Together, these trends signal a shift toward embolization technologies that are not only technically effective at the time of procedure, but also designed with long-term vessel healing and regulatory scrutiny in mind.