OrthoSensor receives CE Mark approval for knee system
OrthoSensor received CE Mark approval for the VERASENSE Knee System, the first integrated, intelligent orthopaedic device to aid surgeons in total knee replacement surgery. The company announced in a press release that it now plans to launch VERASENSE in Europe.
The intelligent single-use VERASENSE Knee System replaces the standard plastic tibial trial spacer used during knee replacement surgery, as stated in the press release. With proprietary software and advanced sensor and real-time data communications, it allows surgeons to make clinical decisions about implant placement, limb alignment and soft tissue balancing based on real-time quantitative data.
“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 U.S. and creates significant growth opportunities for our business,” Jay Pierce, president and chief operating officer of OrthoSensor, stated in the press release.
VERASENSE is compatible for use with several total knee replacement (TKR) implant systems. The FDA cleared it for use with TKR in 2009 and for use with limb alignment in 2013.