Zimmer Biomet said the FDA has granted Breakthrough Device Designation for the company's iodine-treated total hip replacement system. This is the first product in Zimmer Biomet history to receive this designation.
Iodine technology integrates a controlled-release iodine surface treatment into the iTaperloc Complete and iG7 Hip System to help address challenges associated with joint replacement procedures for patients at higher risk of infection. This system recently received approval from the Japan Pharmaceutical and Medical Devices Agency (PMDA) in September, becoming the world's first approved orthopedic implant with Iodine Technology.
Indications in Japan include inhibiting bacterial adhesion on the implant surface, which is designed to address the challenging complication of Periprosthetic Joint Infections (PJI) associated with total joint arthroplasties (TJA). PJIs are estimated to occur in 1% to 2% of primary TJA procedures and can have serious consequences, with mortality rates approaching the five-year mortality observed in breast cancer (11%) and far exceeding that of prostate cancer (1%).
The iTaperloc Complete and iG7 Hip System combines the long-standing clinical heritage of the Taperloc Complete Hip System and the simplicity, efficiency and performance of the G7 Acetabular System with Iodine Technology. Iodine is a biocompatible, essential nutrient that does not cause antibiotic resistance and is commonly used in medicine as an antiseptic.
The FDA Breakthrough Devices Program offers manufacturers an opportunity to interact with experts from the agency to efficiently address topics as they arise during the regulatory review process. According to the FDA, the program provides a prioritized review of submissions and is designed to help device manufacturers receive more timely feedback from the FDA.
