OrthoSensor received FDA clearance for its Verasense sensor-assisted technology to be used with Zimmer Biomet's Persona Knee System for total knee replacement.
Here are four notes:
1. The Verasense device provides real-time, quantified soft tissue balance data to help surgeons make objective assessments intraoperatively.
2. Verasense is intended to improve knee balance and implant positioning to prevent premature implant failure and the need for future revision surgery.
3. In a prospective multi-center study, 98 percent of patients whose knees were balanced using Verasense reported being satisfied or very satisfied at three years after surgery.
4. Earlier this year, OrthoSensor won approval to use Verasense with the Persona Knee System in Australia.
"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," said OrthoSensor President and CEO Ivan Delevic.