Developers: | Paragon 28 |
Date of the premiere of the system: | September 2023 |
Branches: | Pharmaceuticals, Medicine, Healthcare |
2023: Product Announcement
On September 11, 2023, the American company Paragon 28 announced the Smart Total Talus System implant to replace the talus. The solution can be used in conjunction with the Apex 3D Total Ankle Replacement System.
The Apex 3D Total Ankle Replacement System platform consists of three anatomical shape components. The system, optimized for surgeon preferences, is based on more than a century of clinical experience and the latest biomechanical technologies. The product can be used for a wide range of ailments associated with ankle arthritis. It is an acute inflammatory disease of the cartilaginous tissue of the joint, synovial sheath and near-articular bag. Paragon 28 claims that the system solves common problems such as implant loosening, pathological wear, instability and persistent pain.
Paragon 28 reported receiving approval from the U.S. Food and Drug Administration (FDA) to conduct clinical safety and efficacy studies of the Smart Total Talus System. The implant is supposed to be the only device on the market designed to replace talus in adjacent joint arthritis.
The development of the implant is part of the large-scale Smart 28 initiative - the Paragon 28 ecosystem, which includes technologies for preoperative planning, support during procedures and postoperative assessment. The main goals of the Smart 28 are to expand the capabilities of surgeons and improve the treatment results of patients suffering from foot and ankle diseases. Comprehensive tests of the Smart Total Talus System will be organized in early 2024.[1]