Verasense™ EU Launch follows CE Mark

OrthoSensor™ has announced 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.

Background

FDA originally cleared Verasense in 2009 and updated that clearance to include limb alignment in June, 2013 as we reported. OrthoSensor describes its system as an intelligent single-use instrument system that replaces the standard plastic tibial trial spacer used during knee replacement surgery. The system’s 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.

Company comments

“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.”

Source: Orthosensor, Inc., PR Newswire