Balt USA Receives FDA 510(k) Clearance of the Optima Coil System

Balt USA has received U.S. Food and Drug Administration 510(k) clearance for the Optima Coil System and has completed its first clinical cases in the United States. The Optima Coil System consists of 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.
 
“The clearance of the Optima Coil system is a significant step towards Balt’s vision of bringing our 40-year legacy of innovation to the U.S. market,” said Nicolas Plowiecki, president of Balt.

“This is the first of several Balt product approvals anticipated in 2018, which will enable U.S. physicians access to unique, life-saving technologies that they have seen at international conferences for years, but have not been available in their practice,” added Pascal Girin, CEO of Balt International.
 
More than 60 clinical cases utilizing 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 Dr. Satoshi Tateshima, professor of the Division of Interventional Neuroradiology at Ronald Reagan UCLA Medical Center in Los Angeles, Calif. “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.”
 
The Optima Coil System is one first products being manufactured at Balt USA’s new 60,000-square-foot headquarters in Irvine, Calif., which opened its doors in November 2017 and completed validation in January. The new facility will allow Balt to be the first neurovascular company to offer research and development and manufacturing in both Europe and the United States.
 
Balt USA LLC was established in 2017 as the U.S.-based division of Balt Incorporated and is based in Irvine, Calif. Balt USA’s focus is on the commercialization of Balt products in the United States as well as continuing a tradition of physician-inspired innovation through research and development.
 
Since it was established in 1977, BALT has worked with interventional neuroradiologists to treat complex life-threatening conditions such as strokes, aneurysms and arteriovenous malformations. BALT designs, manufactures and distributes interventional neuro radiology (INR) devices such as catheters, stents and coils. BALT is now entering with innovating solutions into the interventional radiology area with a portfolio around embolization solutions with liquid embolic agent and coils. BALT is a pure-play European medtech firm, and is a supplier to all major international hospitals practicing neuroradiology surgery. Headquartered in France, it boasts a number of proprietary, patent-protected products focusing on minimally invasive neurovascular techniques and recently peripheral diseases. In 2017, the company generated 95 percent of its revenue outside France via its own sales network and over 100 distributing countries worldwide.