Orthopaedic device company OrthoSensor Inc reported on Monday that it has received 510(K) clearance from the US Food and Drug Administration (FDA) for the use of its VERASENSE Sensor-Assisted Technology (VERASENSE) for total knee replacement.

The US Food and Drug Administration (FDA) has approved the company's VERASENSE Sensor-Assisted Technology (VERASENSE) to be used with Zimmer Biomet's Persona Knee System for total knee replacement.

According to the company, VERASENSE harnesses the latest innovations in sensors and wireless communications for primary and revision total knee replacement (TKR) during surgery, with the goals of improving patient outcomes and satisfaction. Earlier this year, Dr Lachlan Host from Bathurst Private Hospital in Australia successfully used VERASENSE for Persona Knee System for the first time.

Under the company's prospective multi-center study, VERASENSE use was proven to reduce post-operative pain, accelerate patient activity levels, improve functional outcomes as well as increase patient satisfaction scores with high statistical significance. About 98% of patients whose knees were balanced using VERASENSE were satisfied at three years post-op. These proven results point to improved joint balance being the key to higher TKR satisfaction.

Approximately one in every five TKR patients is dissatisfied with the results of their surgery. The subjectivity of total knee replacement, coupled with improper soft tissue balance and implant position, may result in premature implant failure and the need for revision surgery in the future.