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Technology already sold in the United States.
Dania Beach, Fla.-based OrthoSensor Inc. will be rolling out its Verasense knee system throughout Europe following its recent CE mark approval. Verasense is a single-use instrument system that replaces the standard plastic tibial trial spacer used during knee replacement surgery. It is designed to be used with different knee implant systems. The company claims the device is the first “integrated intelligent orthopedic” system to provide surgeons with real-time quantitative data on knee implant positioning, limb alignment and soft-tissue balance during total knee replacement surgery. Approval in the EU creates “significant growth opportunities” for the company said Jay Pierce, president and CEO. 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. The first clinical use was September 2011.
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