OrthoSensor said today it won FDA 510(k) clearance for its Verasense sensor-assisted device designed to be used with Zimmer Biomet‘s (NYSE:ZBH) Persona knee system during total knee replacement procedures.
The newly cleared Verasense device uses advanced sensors and wireless connectivity to analyze knee balance and improve outcomes during total knee procedures using the Persona knee system, the Dania Beach, Fla.-based company said.
“Using Verasense has completely changed my joint arthroplasty practice. Since using Verasense, I have found patients have consistently improved range of motion and have had less focal pain. I now know, irrefutably, that I am achieving improved patient outcomes,” Dr. Lachlan Host of Australia’s Bathurst Private Hospital, who used the Verasense in a Persona knee system procedure for the first time, said in a prepared statement.
Data from a prospective multi-center study of the Verasense showed the system was able to reduce post-operative pain, accelerate patient activity levels, improve functional outcomes and increase patient satisfaction scores. Results indicated that 98% of patients whose knees were balanced using Verasense saying they were satisfied to very satisfied with the procedures at three years post-operation, OrthoSensor said.
“Receiving FDA clearance for Verasense use with the Zimmer Biomet Persona Knee System, augments this outstanding implant and instrumentation, securing a better balanced knee after surgery. The Verasense device brings real-time, quantified soft tissue balance data to our surgeons. This evidenced-based data regarding soft tissue balance works with systems such as Persona so that surgeons can make objective assessments intraoperatively, resulting in better clinical outcomes for patients,” prez & CEO Ivan Delevicsaid in a press release.