Vexim Receives FDA Approval for Marketing of New Cement System

The Masterflow system, in development for nearly two 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 news 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.

Combined with Vexim’s Cohesion Bone Cement, FDA-approved since 2011, the Masterflow system optimizes each stage of the injection process allowing a complete focus on the surgical case. Product features include: precise control of the cement injection with immediate halting of the flow, safe and secure technique for the physician and patient, and clinical performance enhancement.

The Masterflow Injection System will enable Vexim to target the U.S. back trauma market (vertebral augmentation market), estimated to total $500 million, or 60 percent of the global market. Vexim plans to launch the Masterflow System during the first half of 2015.

“Following the establishment of a local distribution network via the creation of our U.S. subsidiary, this FDA registration of the Masterflow Injection System marks the next milestone in our U.S. strategy that is suited to this market: to quickly break into the vertebral augmentation segment and establish a positive track record and reputation in advance of delivering our flagship SpineJack product, the registration of which is in process,” said Vexim CEOVincent Gardès.‎

Based in Balma, France, Vexim specializes in the minimally invasive treatment of vertebral fractures.