Optima Coil System receives 510(k) clearance

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The Optima Coil System has received 510(k) clearance and has reached completion of the first clinical cases in the United States. The Optima Coil System consists of a state-of-the art coil, a novel pusher and an instantaneous thermal detachment system.

The clearance of the Optima Coil System marks the first Balt USA product to have been developed and cleared for use in the United States.

More than 60 clinical cases using the Optima Coil System were successfully completed with positive physician feedback during the limited market release in Europe. The Optima Coil System has now moved to full market release in Europe and a limited market release is now underway in the United States.

“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,” said Satoshi Tateshima, Professor of the Division of Interventional Neuroradiology at Ronald Reagan UCLA Medical Center in Los Angeles, California, USA. “The innovation in the pusher design provides significant improvements over other coils in the market place and will enable physicians to treat the most difficult cases with confidence.”

Balt USA LLC was established in 2017 as the US based division of Balt Incorporated and is based in Irvine, California, USA. Balt USA’s focus is on the commercialisation of Balt products in the United States as well as continuing a tradition of physician inspired innovation through novel research and development.

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