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Product / Company Performance

Episurf Medical Gains FDA Approval for IDE Study -

Episurf Medical received FDA approval for its Investigational Device Exemption (IDE) application to initiate a clinical trial of the Episealer® knee implant. The two-year prospective, randomized, controlled, multi-center study will evaluate the device vs. microfracture in the treatment of focal femoral knee chondral or osteochondral lesions in 180 patients in the U.S. and Europe. Patient enrollment may start once Institutional Review Board approval is obtained. Additional conditions must be met to address minor outstanding issues, but these have not raised concerns that preclude FDA from granting approval. (Episurf Medical AB, 12/17/18)