CLINICAL SAFETY STUDY AT MEEI. A prospective, open-label clinical safety study was conducted at MEEI in 15 subjects who were scheduled to undergo a limited rhytidectomy (mini-facelift) procedure (Protocol Number 05-06-032). The study was approved by the MEEI Human Studies Committee (the Institutional Review Board [IRB]), and all subjects signed the informed consent document. The objective of this clinical study was to confirm the conclusion that the Ulthera® System provides controlled thermal micro-coagulative zones in the dermis while sparing the epidermis. Safety was assessed in terms of skin inflammation, pain, adverse events, and histology. Subjects were treated with the Ulthera® System either approximately 24 hours before or 4 to 12 weeks before undergoing a mini-facelift. The investigator performed treatment using the Ulthera® System according to the instructions provided in the protocol and based upon the treatment plans verified and validated in prior preclinical testing. The investigator selected the transducer and then performed one of three treatment plans on the portion of the face and neck that would be subsequently excised during the mini-facelift. Fifteen subjects were treated; 7 subjects underwent the facelift surgery within 24 hours following treatment with the Ulthera® System and 8 subjects underwent the facelift surgery within 4 to 12 weeks after treatment. During treatment, 1,300 ultrasound exposure pulses were delivered using three different transducers, including the 7- 4.5mm, 7-3.0mm, and 4-4.5mm transducers. There was no disruption to the epidermis noted in any subject, no adverse events noted, and no delayed adverse sequelae to the treated skin. The skin tissue was excised during the mini-facelift procedure either immediately or 4 to 12 weeks after treatment. The tissue was frozen, sectioned, and stained for gross and histopathology evaluation. Histopathology analysis of acute samples of skin tissue treated with the Ulthera® System (within 24 hours) showed thermal coagulative zones below the skin epidermis with complete epidermal preservation. Histopathology was also performed on the tissue excised from those subjects who underwent a delayed facelift (4 to 12 weeks following treatment with the Ulthera® System). No definitive findings of discrete coagulative changes were observed in the delayed cases, and there were no findings of extensive fibrous tissue or tissue scarring. The Ulthera® System was determined to be safe for delivery of targeted, precise, and cons...
