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June 25, 2025
Embolization Inc.’s Nonmetal Coil Device Receives FDA Clearance
June 25, 2025—Embolization, Inc., a medical device company based in Boulder, Colorado, announced its nitinol-enhanced device (NED) has received FDA 510(k) clearance. The NED is a vascular embolization device intended for arterial and venous embolization in peripheral vasculature.
Embolization, Inc. advised it will move toward commercialization and market introduction of the NED.
The company stated that its coil devices use the company’s shape-memory biocompatible polymers to achieve better vascular occlusion while minimizing artifacts in MRI and CT imaging that occur with metal devices. The coils are radiopaque under fluoroscopy even though the CT/MRI imaging artifact is minimal, noted the company.
The company noted that in animal studies, its nonmetal coils showed reduction in shadowing or obscuration on imaging scans; easier repeat embolizations; faster, more reliable embolization; and ease of use through a 1-mm diameter implantation tool.
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