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Multispecialty contralateral study of clinical experience with the Ultratine forehead fixation device: evolution of the original Endotine device.

S ince the introduction of the Endotine forehead fixation device (Coapt Systems, Palo Alto, California) in March 2003, there has been widespread acceptance of the product. The device has been implanted in over 40 000 patients, and its safety and efficacy have been documented by numerous multispecialty clinical studies. Although the device has provided satisfactory elevation and fixation for endoscopic and open and coronal forehead-lifts, a small percentage of surgeons and patients have complained of problems related to persistent palpability and sensitivity owing to the 12to 15-month absorption time of the biodegradable polymer. The Ultratine forehead fixation device (Coapt) was cleared by the US Food and Drug Administration in 2006. It has the same dimensions as the original device, but the composition of the polymer has been altered to different percentages of polylactic acid and polyglycolic acid (PLA-PGA) designed for absorption and biodegradation starting at the 2to 3-month interval. In July 2006, a multispecialty contralateral study was undertaken comparing the original Endotine to the new Ultratine in a partially blinded contralateral study. The goal was to determine end user (surgeon and patient) satisfaction with the performance of the device. Twelve patients completed the study at 90 days, and physicians rated the overall performance as good or satisfactory at a 100% level.