Orthovita, Inc., a spine and orthopedic biosurgery company, announced that it has submitted a 510(k) filing to the U.S. Food and Drug Administration for the use of its CORTOSS Bone Augmentation Material in vertebral augmentation.
This filing is based on data collected in three U.S. clinical investigations conducted under FDA Investigational Device Exemptions (IDEs) and several European studies, and is intended to demonstrate that the performance of CORTOSS is substantially equivalent to polymethylmethacrylate (PMMA) bone cement. The extensive clinical study of CORTOSS demonstrates that the same degree of clinical improvement in pain and function is achieved with approximately 40% less material than PMMA when augmenting the vertebral body. CORTOSS also provides other benefits, including consistent handling characteristics and viscosity.
The CORTOSS 510(k) filing includes data on 469 vertebral compression fracture patients treated with CORTOSS and 94 patients treated with PMMA with follow up ranging from 11 months to over 3 years. This data includes results from Orthovita’s pivotal, prospective, randomized clinical study conducted under an FDA IDE. In the pivotal study, a total of 162 patients were treated with CORTOSS and 94 patients were treated with PMMA. Two-year follow up for all 256 of the pivotal study patients will be completed in February 2009.
“The 510(k) filing is a key step toward the introduction of CORTOSS to the U.S. market as an alternative to PMMA bone cement for the treatment of vertebral compression fractures. To the Company’s knowledge, the CORTOSS 510(k) filing contains the largest prospective, randomized, controlled clinical dataset ever assembled in the treatment of vertebral compression fractures. We would like to express our gratitude to all our investigators and their personnel for their hard work and invaluable contributions that helped us achieve this milestone,” said Antony Koblish, President and Chief Executive Officer of Orthovita.
Source: Orthovita, Inc.