Integra LifeSciences Holdings Corporation announced the full commercial launch of its Cadence Total Ankle System.
According to a company press release, the system was developed by four top foot and ankle surgeons and has been used successfully in more than 200 procedures since its initial clinical use more than 1 year ago. In that time, instrumentation updates and enhanced surgeon training have been introduced to further improve quality, patient safety and procedural efficiency.
Key features of the system include side-specific, anatomical tibial components to avoid fibular impingement; side-specific, anatomical talar components to minimize resected talar bone and preserve vascularity in the ankle; bearing insert components manufactured from a highly crosslinked ultra-high molecular-weight polyethylene for improved wear characteristics; and patent-pending biased sagittal profile options for patients with subluxed talar anatomy.
According to the release, Integra has completed all corrective actions necessary to close the FDA recall related to the clarification of the system surgical technique, which was issued due to a small percentage of intraoperative posterior tibial fractures that occurred due to technique error.
“The recall required no return of product, and since the implementation of the clarified surgical technique, no subsequent posterior tibial fractures have occurred in more than 100 procedures,” according to the release. Integra is planning several post-market clinical studies to further demonstrate efficacy of the system.