Shape Memory Medical Inc., a company focused on advancing shape memory polymer technology for endovascular treatments, has announced that its IMPEDE Embolization Plug product family has achieved certification as a Class III medical device under the European Union Medical Device Regulation 2017/745. The IMPEDE platform was previously approved under the former Medical Device Directive 93/42/EEC and has now successfully met the significantly more rigorous requirements of the EU MDR, well ahead of the 2027 transition deadline for Class III and implantable devices.
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Ted Ruppel, President and Chief Executive Officer of Shape Memory Medical, stated that achieving EU MDR certification represents an important step for the company and its mission to deliver innovative solutions for endovascular disease. He explained that the certification reflects the quality of the company’s clinical evidence as well as the strong collaboration with physicians and research partners across global clinical programs. According to Ruppel, the approval reinforces confidence in the IMPEDE platform and supports broader access to advanced vascular therapies throughout Europe.
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The EU MDR framework introduces enhanced expectations for medical device manufacturers, including stricter standards for safety evaluation, risk control, clinical validation, and post market oversight. Shape Memory Medical emphasized that the IMPEDE Embolization Plug family benefited from extensive clinical use and real world performance data, which played a central role in the regulatory review process. The MDR certification helps ensure continued availability of the device family across European healthcare systems and supports consistent quality, traceability, and performance for physicians and patients.
The IMPEDE Embolization Plug portfolio includes the IMPEDE Embolization Plug, the IMPEDE-FX Embolization Plug, and IMPEDE-FX RapidFill. Each product is built using a proprietary shape memory polymer designed to promote vessel thrombosis. The material is compressed for catheter delivery and then expands when exposed to blood, creating a porous scaffold that enables rapid vessel occlusion. Its soft and adaptable structure allows effective volume filling without applying outward pressure on the vessel wall, while its radiolucent nature enhances visibility during imaging both during procedures and in follow-up evaluations.
In addition to its approved peripheral vascular indications, Shape Memory Medical is continuing to expand the clinical potential of the IMPEDE platform through ongoing research. The company is currently conducting the AAA-SHAPE trial, a prospective, randomized, multicenter study designed to assess the safety and effectiveness of the IMPEDE-FX RapidFill device when used alongside elective endovascular aneurysm repair. The study will enroll up to 180 patients with follow-up extending to five years, and enrollment is expected to conclude in 2026.
At the same time, Shape Memory Medical is preparing to launch the FLAGSHIP study, a first in human clinical investigation of a next generation large diameter shape memory polymer system. This new system is being developed specifically for false lumen embolization in aortic dissection, further broadening the company’s portfolio and reinforcing its long term commitment to innovation in vascular and aortic care.
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