Vexim receives FDA approval for marketing of new cement system
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Vexim announced recently that the U.S. Food and Drug Administration has approved the company’s Masterflow Injection System, designed for mixing and injecting orthopedic cement, for marketing within the U.S.
The Masterflow system, which was in development for nearly 2 years, controls the injection of ultra-high-viscosity cement for the treatment of vertebral fractures where reducing and stabilizing the fracture is the priority, according to a company press release.
Vexim acquired a worldwide license in January 2013 for the system, which is protected by international patents granted in the United States, Europe and China.
The new system enables the company to target the U.S. back trauma market (vertebral augmentation market), which is estimated to total $500 million, or 60% of the global market.
The company plans to release the system in Europe during the first half of 2015, according to the release.
Reference: www.vexim.fr.