US-based OrthoSensor has announced its plans to launch its Verasense knee system in European markets after recently receiving CE Mark approval.
US-based OrthoSensor has announced its plans to launch its Verasense knee system in European markets after recently receiving CE Mark approval.
It is reportedly the first integrated intelligent orthopaedic device intended to reduce the incidence of malalignment and imbalance in total knee arthroplasty.
Verasense empowers the surgeons with real-time quantitative data to enable evidence-based decisions on knee implant positioning, limb alignment and soft tissue balance during total knee replacement surgery.
OrthoSensor president and CEO Jay Pierce said the company has successfully achieved CE Mark for its 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," Pierce added.
"It's a vital step toward expanding our business internationally."
In 2009, the US Food and Drug Administration (FDA) had cleared Verasense system for use in total knee replacement procedures and received FDA clearance for limb alignment earlier this year. First clinical use was in September 2011.
The intelligent single-use instrument system replaces the standard plastic tibial trial spacer used during knee replacement surgery and is compatible for use with multiple leading knee implant systems.