FDA extends Exogen device approval

Smith & Nephew Orthopaedics of Memphis, TN, announced last week that it has received premarket approval from the FDA to market its Exogen 2000, a noninvasive ultrasound fracture therapy, for the treatment of established nonunion bone fractures.

The FDA approved the Exogen device in 1994 as a treatment for the acceleration of fresh fracture healing. With this PMA, Exogen becomes the only bone stimulation treatment available for both fresh and nonunion fractures. Currently, the therapy has been prescribed for more than 18,000 patients in the U.S. by more than 7000 physicians.

A nonunion is considered to be established when a fracture is at least nine months old and has shown no progression of healing for at least three months. According to Smith & Nephew, their clinical studies for the PMA resulted in an 86% healed rate for nonunion fractures that failed to heal after prior orthopedic treatment. Exogen’s proprietary ultrasound and mechanical stress technologies are based on the principle that bone growth is stimulated by mechanical force.