Balt USA’s Optima Coil System Granted 510(k) Clearance

The FDA gave Balt USA 510(k) clearance for its Optima coil system, a product used in the treatment of aneurysms.

The system consists of a coil, pusher and instantaneous thermal detachment system, and has moved to full market release in Europe, with a limited market release ongoing in the U.S.

The Optima provides physicians a soft coiling and rapid detachment system to help them treat difficult cases of complex aneurysms.