FDA Clears Balt's Optima Coil System for Neurovascular Procedures

March 20, 2018—Balt USA announced 510(k) clearance from the US Food and Drug Administration for the company's Optima coil system and the completion of the first clinical cases with the device in the United States, where a limited market release is now underway. The Optima system consists of a coil, pusher, and instantaneous thermal detachment system.

Balt USA is part of France-based Balt Incorporated, a developer and manufacturer of devices for interventional neuroradiology procedures to treat strokes, aneurysms, and arteriovenous malformations. This is the company's first product to be available in the United States and is one of the first products manufactured at Balt USA’s new headquarters in Irvine, California, which opened in November 2017.

The company noted that during the device's limited market release in Europe, more than 60 clinical cases with the Optima coil system were successfully completed, and a full market release is underway in Europe.

Satoshi Tateshima, MD, commented in the company's announcement, “The Optima coil system provides physicians with an extremely soft coiling system and a rapid and reliable detachment system to aid us in the treatment of complex aneurysms. The innovation in the pusher design provides significant improvements over other coils in the marketplace and will enable physicians to treat the most difficult cases with confidence.” Dr. Tateshima is Professor of the Division of Interventional Neuroradiology at Ronald Reagan UCLA Medical Center in Los Angeles, California.