FDA Grants IDE Feasibility Study Approval for Paragon 28®, Inc.'s SMART Total Talus™ System in Conjunction with APEX 3D™ Total Ankle Replacement
Monday, September 11, 2023
Paragon 28, Inc., trading under the ticker symbol FNA on the New York Stock Exchange, announced today that it has received approval for an Investigational Device Exemption (IDE) from the FDA. This approval allows them to initiate a feasibility study concerning various configurations of the SMART Total Talus™ System when used alongside the Paragon 28® APEX 3D™ Total Ankle Replacement System. The commencement of this study is anticipated in early 2024.
This achievement represents a significant milestone in advancing Paragon 28's SMART 28℠ strategy. This strategy is designed to provide valuable choices to surgeons and ultimately enhance patient outcomes. The IDE for the SMART Total Talus expands the company's existing offering of Patient-Specific Total Talus, making this technology available as an option for potential candidates requiring total ankle replacement.
Notably, Paragon 28 acquired Additive Orthopaedics in June 2021, securing the first and only FDA-approved Patient-Specific Total Talus replacement for the treatment of avascular necrosis (AVN). With the IDE approval to support future regulatory submissions, the SMART Total Talus is positioned to become the sole device in the market intended for talar replacement in cases involving adjacent joint arthritis.
Albert DaCosta, CEO of Paragon 28, expressed, "The approval of this IDE study exemplifies our unwavering commitment to improving the lives of patients suffering from foot and ankle conditions. It is a significant advancement for our SMART 28 ecosystem and our comprehensive total ankle portfolio. We are gratified that the FDA recognizes the potential benefits of expanding access to this technology for a broader range of ankle patients, and we eagerly await the commencement of this IDE study."
Paragon 28 extends its sincere gratitude to the FDA for their valuable guidance throughout the IDE approval process. The company looks forward to continued collaboration with the FDA, healthcare professionals, and participating institutions as the IDE study progresses.