OrthoSensor Receives CE Mark Approval for VERASENSE

OrthoSensor announced today plans to launch its VERASENSE Knee System in European markets after recently receiving CE Mark approval. VERASENSE is the first integrated intelligent orthopaedic device to provide surgeons with real-time quantitative data on knee implant positioning, limb alignment and soft tissue balance during total knee replacement surgery.

"We're pleased to have successfully achieved CE Mark for our VERASENSE technology. This enables us to provide OrthoSensor's innovative technology to orthopaedic surgeons and patients in markets outside the US and creates significant growth opportunities for our business," said Jay Pierce, President and CEO of OrthoSensor, Inc. "It's a vital step toward expanding our business internationally."

VERASENSE was cleared for use in total knee replacement procedures by the U.S. Food and Drug Administration (FDA) in 2009 and received FDA clearance for limb alignment earlier this year. First clinical use was September 2011.

The VERASENSE Knee System is an intelligent single-use instrument system that replaces the standard plastic tibial trial spacer used during knee replacement surgery. VERASENSE proprietary software and advanced sensor and real-time data communications technologies empower surgeons to make evidence-based decisions regarding component placement, limb alignment and soft tissue balance to achieve balance and stability through a full range of motion with the goal of optimizing clinical outcomes and enhancing patient satisfaction.

VERASENSE integrates seamlessly into the surgical workflow and is compatible for use with multiple leading knee implant systems.