The company has submitted results from the two-year follow-up for patients enrolled in the Cortoss pivotal study.
Orthovita recently announced that it has submitted additional data to the FDA in support of its 510(k) filing for the use of its Cortoss Bone Augmentation Material in vertebral augmentation.
This 510(k) application is intended to demonstrate that the performance of Cortoss is substantially equivalent to polymethylmethacrylate (PMMA) bone cement.
The data submitted today includes two-year follow-up data from Orthovita’s pivotal, prospective, randomised, multisite clinical study conducted under an FDA investigational device exemption (IDE).
In the pivotal study, a total of 162 patients were treated with Cortoss and 94 patients were treated with PMMA. The two-year follow-up period has now been completed for the pivotal study.
In addition to two-year follow-up clinical data for patients enrolled in the pivotal study, Orthovita has submitted to FDA data on patients from two pilot clinical investigations in the USA, conducted under FDA IDEs and from several European studies with follow-up ranging from 11 months to over 4 years.
“To our knowledge, the Cortoss 510(k) filing contains the largest prospective, randomised, controlled clinical dataset ever assembled in the treatment of vertebral compression fractures. We are pleased with the high rate of follow-up that we obtained in the geriatric patient population that was enrolled in our pivotal study. We recognise and very much appreciate the diligence and tremendous effort shown by our clinical investigators and their staff in obtaining this critical, long-term data,” said Dr. Maarten Persenaire, Orthovita’s Chief Medical Officer.
FDA clearance of Cortoss would permit Orthovita to market and sell the material in the United States for vertebral augmentation. Cortoss has CE Certification for use in the European Union for screw augmentation, and for vertebral augmentation. This enables Cortoss to be sold in the European Union as well as in other countries that have adopted the European Union’s regulatory standards.