OrthoSensor Receives CE Mark Approval for VERASENSE™
European Launch of VERASENSE to Provide Surgeons Quantifiable Data to Assist with Implant Positioning and Balance in Total Knee Replacement Procedures
DANIA BEACH, Fla, (October 4, 2013) – OrthoSensor announced today plans to launch its lead product VERASENSE 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 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 its first clinical use was September 2011.
VERASENSE 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 and soft tissue balance to improve balance and stability through a full range of motion with the goal of improving patient outcomes and satisfaction.
VERASENSE integrates seamlessly into the surgical workflow and is compatible for use with multiple leading knee implant systems.
About OrthoSensor, Inc.
OrthoSensor, Inc., a leader in Sensor-Assisted Total Knee Arthroplasty develops and commercializes intelligent orthopaedic devices and data services that provide quantitative feedback to surgeons and hospitals. The company’s intelligent orthopaedic devices utilize advanced proprietary sensor and communications technologies, coupled with the company’s innovative software products, to facilitate evidence-based decisions in orthopaedic surgery – with the goal of improving patient outcomes and potentially reducing the cost of treating musculoskeletal disease.
OrthoSensor® and VERASENSE™ are trademarks of OrthoSensor, Inc.