Safety and Efficay of BION Implant During Radiation Therapy

Abstract

Objective To determine the safety and efficacy of BION implants during radiation therapy (XRT) of head and neck cancer (HNC). The implants were placed to treat complications of muscle disuse for swallowing. Methods Three patients who underwent surgery for HNC received BION implants. The study was conducted under rules of good clinical practice under an Investigational Device Exemption from the U.S. FDA and monitored by the University of Southern California IRB. The implant was placed 2–3 mm above and parallel to the hypoglossal nerve just proximal to the origin of the ansa cervicalis. Two patients started XRT 3–4 weeks after surgery. The third patient did not need XRT. Two sets of stimulation protocols are used: low (low frequency, supramaximal twitch) and high (strong, fused contractions - 20–30pps). Results No postoperative or implant specific complication was noted. During radiation therapy, the implants were stimulated. All patients tolerated stimulation without pain or discomfort. Visible contraction of base of the tongue muscles and muscles of laryngeal elevation was observed by using an external coil. All patients received high stimulation. The patients were provided with the coils and they continue to stimulate these muscles at home 3 times a day for a total of 1h/d. All patients maintained their oral feeding and weight during treatment of cancer. Conclusions BION is safe device to implant for stimulation of swallowing muscles. It effectively stimulate the hypoglossal and ansa cervicalis nerves. Robust contraction of swallowing muscles are visible during stimulation.