Embolization, Inc., a medical device company based in Boulder, Colorado, announced on June 25, 2025, that its nitinol-enhanced device (NED) has received FDA 510(k) clearance. The NED represents a significant advancement in vascular embolization technology, designed for arterial and venous embolization in peripheral vasculature.
The company has indicated it will proceed with commercialization and market introduction of the NED following this regulatory milestone.
Innovative Nonmetal Technology
The NED distinguishes itself from conventional embolization devices through its use of shape-memory biocompatible polymers rather than traditional metal components. According to Embolization, Inc., this design approach enables better vascular occlusion while significantly reducing artifacts in MRI and CT imaging that commonly occur with metal-based devices.
Despite being nonmetal, the coils maintain radiopacity under fluoroscopy, ensuring visibility during procedures while minimizing CT/MRI imaging artifacts. This dual capability addresses a longstanding challenge in interventional procedures where imaging clarity is crucial for both procedural guidance and post-treatment monitoring.
Preclinical Performance Data
Animal studies conducted by the company demonstrated several key advantages of the nonmetal coil technology. The studies showed reduction in shadowing or obscuration on imaging scans compared to traditional metal coils, which could improve diagnostic accuracy and treatment monitoring.
The research also indicated that the NED enables easier repeat embolizations when necessary, potentially reducing procedural complexity for patients requiring multiple interventions. Additionally, the studies demonstrated faster and more reliable embolization compared to conventional devices.
Clinical Implementation Features
The device is designed for deployment through a 1-mm diameter implantation tool, which the company notes provides improved ease of use for clinicians. This smaller profile could potentially reduce procedural trauma and improve patient comfort during interventions.
The combination of enhanced imaging compatibility, improved occlusion performance, and streamlined delivery represents a comprehensive approach to addressing current limitations in vascular embolization procedures.
With FDA clearance secured, Embolization, Inc. is positioned to introduce this technology to the peripheral vascular intervention market, potentially offering clinicians and patients an alternative to traditional metal-based embolization devices.
