Sam Brusco, Associate Editor09.11.23
Paragon 28 has received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin a feasibility study for configurations of the SMART Total Talus system in conjunction with the APEX 3D total ankle replacement system. The company said the study is planned to begin in early 2024.
The company said this approval is an important achievement in its SMART 28 strategy to provide meaningful options to surgeon customers and improve outcomes. The SMART Total Talus IDE builds on Paragon 28’s existing patient-specific total talus by expanding the tech’s use as an options for prospective ankle replacement candidates.
The company bought Additive Orthopedics in June 2021, adding the first and only FDA approved patient-specific total talus replacement for avascular necrosis (AVN) treatment to its portfolio. With the IDE approval to bolster future regulatory applications, Paragon 28 said the SMART Total Talus is on the way to become the only device on the market meant for talar replacement in the setting of adjacent joint arthritis.
Paragon 28’s CEO Albert DaCosta told the press, “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.”
The company said this approval is an important achievement in its SMART 28 strategy to provide meaningful options to surgeon customers and improve outcomes. The SMART Total Talus IDE builds on Paragon 28’s existing patient-specific total talus by expanding the tech’s use as an options for prospective ankle replacement candidates.
The company bought Additive Orthopedics in June 2021, adding the first and only FDA approved patient-specific total talus replacement for avascular necrosis (AVN) treatment to its portfolio. With the IDE approval to bolster future regulatory applications, Paragon 28 said the SMART Total Talus is on the way to become the only device on the market meant for talar replacement in the setting of adjacent joint arthritis.
Paragon 28’s CEO Albert DaCosta told the press, “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.”
