IDE enables Paragon 28 to conduct a feasibility study for configurations of Smart Total Talus. It evaluates the system in conjunction with the APEX 3D system. The company expects its study of the talar replacement and ankle replacement systems to begin in early 2024.
Englewood, Colorado-based Paragon 28 says the milestone helps to advance its Smart 28 strategy. Through this strategy, the company aims to provide meaningful options to surgeon customers and significantly improve patient outcomes. Garnering IDE adds to the company’s existing patient-specific total talus offering, the company said. It expands the use of the technology into prospective total ankle replacement candidates.
Paragon 28 acquired Additive Orthopedics in June 2021, adding the company’s FDA-approved, patient-specific Total Talus replacement. It said it seeks to make Smart Total Talus the only device on the market for talar replacement in the setting of adjacent joint arthritis.
“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,” Paragon 28 CEO Albert DaCosta said. “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.”
