Results from a late-stage trial of Amgen’s denosumab in advanced cancer patients with bone metastases showed that the drug delayed skeletal related events such as fracture, radiation to bone, surgery to bone or spinal cord compression. The phase 3 trial compared denosumab administered subcutaneously with FDA approved Zometa, or zoledronic acid, administered as an intravenous infusion to treat bone metastases in 1,776 advanced cancer patients with solid tumors.

Anika Therapeutics Inc, a leader in products for tissue protection, healing and repair based on hyaluronic acid (HA) technology, received approval from Canadian regulators to market Monovisc, an injected treatment for osteoarthritis (OA) of the knee. The product is already being marketed in the European Union (EU). Monovisc is the only single-injection visco-supplement approved for the relief of joint pain in all synovial joints.

The Orthopaedic and Rehabilitation Devices advisory committee has unanimously recommended the FDA approval of DePuy Orthopaedics’ Pinnacle CoMplete Acetabular Hip System, the first ceramic-on-metal hip bearing to be considered for approval in the US. The recommendation was based on the clinical study comparing Pinnacle CoMplete System to a commonly used DePuy metal-on-metal implant on the efficacy and safety. Laboratory testing on the Pinnacle CoMplete System showed a greater than 90% reduction in wear compared to the metal-on-metal system under normal gait conditions and a more than 80% reduction in wear under adverse conditions.

The FDA has approved Austin surgical device maker LDR’s ROI-C cervical cage. This product helps in standalone cervical fusion surgeries, making it less necessary to use thick cervical plates that contribute to dysphagia or difficulty swallowing. LDR CEO Christophe Lavigne said “The entry of the ROI-C cervical cage into the U.S. market represents a huge step for us in continuing to provide innovative, surgeon-friendly solutions for varied spinal pathologies.”