The Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)—the agency that oversees the quality of medical devices made in and imported into Mexico—has approved CTL Amedica Corporation’s Monet anterior cervical interbody fusion (ACIF) system for use in the country.
The Monet ACIF system is specifically designed for ACIF procedures in patients with cervical disc disease. It includes a supplemental fixation plate that provides a “comprehensive solution” for interbody cage fusion, and it is “tailored to meet the diverse anatomical needs of a wide variety of patients”, according to a CTL Amedica press release.
“This milestone is a reflection of our commitment to providing advanced medical solutions that prioritise patient wellbeing and surgical excellence,” said Daniel Chon, chief executive officer of CTL Amedica. “We remain steadfast in our commitment to advancing spine technology and empowering individuals to lead healthier, more fulfilling lives.”
The company says that key features of the Monet ACIF system include the fact it is suitable for skeletally mature patients; is designed for single-level fusion, covering disc levels C2 to C7; includes a supplemental fixation plate for added stability; and is available in a wide variety of sizes and configurations.
The system is available as either a two-hole or four-hole plate system with various cage options. These include traditional polyetheretherketone (PEEK), as well as CTL Amedica’s proprietary titanium (TiCRO) and silicon nitride options.
The company claims that its TiCRO surface technology offers a greater surface area over predicates, “significantly increasing bony endplate contact”, while silicon nitride demonstrates greater protein absorption and increased osseointegration, promotes better bone growth, enhances osteogenic response, and accelerates fusion.