The 1995 meeting of the International Association of Plastic and Reconstructive Surgeons affirmed that, during the next decade, bone distraction has the potential to replace many complex craniofacial surgical procedures currently in use or allow procedures to be performed that were not technically feasible in the past. MSD's product objective, a completely buried bone distraction system suitable for craniomaxillofacial applications powered by an electronically controlled Nitinol actuator, will distract both osteotomy sites and patent craniofacial sutures automatically with small, precise, and frequent incrementation to mimics continuous growth and thus improve osteogenesis. The buried system includes: i) a small encapsulated distractor unit that incorporates an integral Nitinol actuator to mechanically power the unit; ii) buried electronic control circuitry that both monitors the system and also times the application of electric current to the Nitinol actuator to produce incremental distraction; and, iii) an implantable battery to power the system for up to 30 days operation. Required implantable battery and micro-controller technologies are well within """"""""state-of-the-art."""""""" Under this Phase II proposal, the distractor system will be i) completely designed and prototyped, ii) tested both on the bench and in appropriate animal models, and, lastly, iii) undergo biocompatibility testing by an accredited laboratory in preparation for an FDA submission and human trials.
In the United States, 134 centers perform approximately 7,000 intracranial, craniofacial and orthognathic procedures annually. However, 11 centers in four states currently perform over 41 percent of the total procedures, averaging over 250 procedures per year. Such a high concentration of surgical activity provides a substantial opportunity for MSD's distractor to gain substantial and rapid market acceptance. It is estimated that currently 30 percent-40 percent of the total 7,000 surgical procedures performed in these specialized centers could immediately benefit from a clinically suitable distractor. MSD also expects that its distractor will be used to replace approximately one-half of the craniofacial bone grafting procedures within three years due to the significant cost savings that MSD's distractor provides.
