Zimmer Biomet (NYSE: ZBH) announced today that it received FDA breakthrough device designation for its iodine-treated total hip replacement system.
The company said it’s the world’s first iodine-treated total hip replacement. It also marks the first Zimmer Biomet product in history to receive the breakthrough designation, according to a news release. The breakthrough nod comes a month after the orthopedic giant received Japanese approval for the iodine-treated hip system. That made it the world’s first approved orthopedic implant with iodine technology.
Earlier this year, on the company’s first-quarter earnings call, Chair, President and CEO Ivan Tornos called the technology “transformational.”
Iodine technology integrates a controlled-release iodine surface treatment into the iTaperloc Complete and iG7 hip system. This helps to address the challenges associated with joint replacement procedures for patients at a higher risk of infection. The company says the implant can inhibit bacterial adhesion on the implant surface. This addresses preiprosthetic joint infections (PJI) associated with total joint arthroplasties (TJA).
Zimmer Biomet’s iTaperloc Complete and iG7 hip system combines the existing standards of the Taperloc complete hip system and the simplicity, efficiency and performance of the company’s G7 acetabular system with iodine technology. Iodine, a biocompatible, essential nutrient, does not cause antibiotic resistance. Common uses in medicine include as an antiseptic.
“The breakthrough device designation from the FDA underscores the need for innovations to reduce complications that can happen with joint replacement procedures and highlights Zimmer Biomet’s commitment to advancing technologies that improve patient outcomes and enhance the overall success of musculoskeletal health interventions,” Tornos said in a ZB news release. “We look forward to working closely with the agency to bring this first-to-world innovation to patients in the United States.”
