CTL Amedica Wins Authorization to Commercialize Valeo II in Mexico

The Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), Mexico's agency overseeing medical device quality, has certified CTL Amedica's Valeo II silicon nitride interbody line. The registration was made with the help of Minimal Medics S.A de C.V.; and the certification will enable CTL Amedica to commercialize and market the Valeo II silicon nitride interbody line in Mexico. 
 
“The Valeo II silicon nitride interbody line provides many advantages for surgeons and their patients, and we are thrilled to start marketing the devices in Mexico. Silicon nitride is the only material to provide osteointegration, bacteriostatic properties and excellent imaging quality. This is important medical technology and we’re grateful for the opportunity to make it readily accessible in Mexico,” CTL Amedica CEO Daniel Chon said.  
 
The certification includes the following Valeo II products:

• Valeo II C – Anterior Cervical Interbody Fusion Device
• Valeo II OL – Bulleted Transforaminal Lumbar Interbody Fusion Device
• Valeo II TL – Curved Transforaminal Lumbar Interbody Fusion Device
• Valeo II AL – Anterior Lumbar Interbody Fusion Device
• Valeo II LL – Lateral Lumbar Interbody Fusion Device

Valeo II interbody devices are made entirely of silicon nitride, an ideal biomaterial. Silicon nitride’s surface chemistry and natural nanostructure topography provide an optimal environment for new bone growth and contribute to its inherent, bacteriostatic behavior. CTL Amedica is the world’s exclusive provider of silicon nitride spine products.
 
In addition, the Valeo II interbody line is semi-radiolucent with clearly visible boundaries and the products produce no distortion under MRI, as well as, no scattering under computed tomography. These favorable imaging qualities enable a precise view of the implants’ operative placement and postoperative fusion assessment.
 
CTL Amedica is a medical device design, development and manufacturing company. CTL Amedica maintains a Texas-based headquarters and in-house manufacturing facility, along with a Pennsylvania-based R&D Center of Excellence. A leader in the medical device technology and biomaterials space, CTL Amedica provides a full line of cervical, thoracic and lumbar fusion and fixation products.