Orthofix Granted PMA for AccelStim Bone Healing Therapy

By Julie A. Vetalice

Orthofix Granted PMA for AccelStim Bone Healing Therapy

FDA granted Premarket Approval of Orthofix Medical's AccelStim™ bone healing therapy Class III device. AccelStim provides a nonsurgical treatment for fresh fractures and those that have not healed. The device generates a Low-Intensity Pulsed Ultrasound (LIPUS) signal to stimulate the bone’s natural healing process to promote fracture healing.

Commercial availability of the AccelStim device is expected in 2Q22.

AccelStim is lightweight, adjustable and portable, and includes a rechargeable battery that allows freedom of movement during treatment. LIPUS technology stimulates bone healing at the molecular, cellular and tissue level and has been observed to accelerate fracture-healing recovery by 38% for indicated fresh fractures and an overall clinical success rate of 86% for nonunions.

Orthofix President of Global Spine Kevin Kenny said, “With the addition of the AccelStim device, Orthofix is now the first and only company to offer both PEMF and LIPUS bone growth stimulation devices, and one of only two companies in the U.S. with a fresh fracture indication.”

Source: Orthofix

Tags: Premarket Approval, Regulatory