Smith & Nephew FDA Approved on Bone Healer

Orthopedic device manufacturer Smith & Nephew has been approved by the FDA to market its Exogen 4000+ bone-healing system in the US. The Exogen 4000+ — intended as a replacement to the company’s predecessor Exogen 2000+ — has been shown to accelerate the healing of certain fractures by 38% and to heal 86% of hard-to-heal bone fractures, according to Smith & Nephew officials.
    The Exogen 4000+ is first low-intensity, pulsed ultrasound bone stimulator to use ultrasound approved to treat broken bone that has failed to heal properly.
    “Receiving FDA approval for the EXOGEN 4000+ Bone Healing System is yet another win for surgeons and patients,” said Ken Reali, vice president and general manager, Orthopaedic Clinical Therapies. “While the accelerated healing potential and non-union treatment capabilities of the system continue to provide the same non-invasive alternative to surgery, the design upgrades make it easier to operate further optimizing patient care.”
    The Memphis, TN-based division said it would launch the new system in the United States and overseas this fall.