ENGLEWOOD, Colo.– Paragon 28, Inc. (NYSE: FNA), announced today they have received an Investigational Device Exemption (IDE) approval from the FDA to commence a feasibility study for configurations of the SMART Total Talus™ System used in conjunction with the Paragon 28® APEX 3D™ Total Ankle Replacement System. The study is expected to begin in early 2024.
This milestone is an important achievement in the advancement of Paragon 28’s SMART 28℠ strategy, which targets to provide meaningful options to their surgeon customers and significantly improve patient outcomes. The IDE of the SMART Total Talus adds to the company’s existing Patient Specific Total Talus offering by expanding use of the technology as an option for prospective total ankle replacement candidates.
Paragon 28 acquired Additive Orthopaedics in June 2021, providing the Company with the first and only FDA approved Patient Specific Total Talus replacement for treatment of avascular necrosis (AVN). With approval of the IDE to support future regulatory applications, the company’s SMART Total Talus is on the path to become the only device on the market intended for talar replacement in the setting of adjacent joint arthritis.
Paragon 28’s CEO, Albert DaCosta, commented, “The approval of this IDE study is another great example of our commitment to improve the lives of patients suffering from foot and ankle conditions, and it is an important advancement for our SMART 28 ecosystem and total ankle portfolio. We are very pleased that the FDA has recognized the potential benefits of expanding access of this technology to more ankle patients, and we are excited to get this IDE study underway.”
Paragon 28 extends its gratitude to the FDA for their guidance throughout this IDE approval process and looks forward to further collaboration with the FDA and healthcare professionals and institutions participating in the IDE study.
