FDA Grants Boston Scientific Clearance for its Embold Fibered Detachable Coil

Boston Scientific has received the FDA’s 510(k) clearance for its Embold fibered detachable coil for reducing or obstructing blood flow in the peripheral vasculature.

The coil is intended for use in a variety of minimally invasive procedures to stop hemorrhaging, prevent aneurysm ruptures, reduce the size of certain tumors and treat a variety of venous abnormalities. It is compatible with multiple catheters, which gives physicians more flexibility and helps reduce the number of device exchanges, the company said.

The first procedure using the device was performed in late April at the University of Alabama at Birmingham. Boston Scientific said it will start marketing the device in the U.S. in the coming weeks.