BOSTON SCIENTIFIC CORPORATION - 2D Helical-35 Fibered Platinum Coil

MRI Safety information for:

2D Helical-35 Fibered Platinum Coil

Conditional

BOSTON SCIENTIFIC CORPORATION

Non-neurovascular embolization coil

Non-clinical testing demonstrates that the 2D Helical-35 Fibered Platinum Coils, will not present additional risk to a patient during a MRI procedure in comparison to risks imposed by gravitational, and other normal daily activities, or a temperature rise that is experienced during a feverish condition. The results of testing conducted under methods described by ASTM F2182-09, ASTM F2052-06e1, ASTM F2213-06 and ASTM F2 119-07 have demonstrated that the Coils are MR Conditional