Study To Evaluate The Safety And Efficacy Of The MyEllevate® Procedure

Exclusion Criteria

• •Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
• •Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.
• •Have received any treatments or procedures (including injectables such as Botox or fillers) in the area to be treated at least 4 months prior to treatment.
• •Take antiplatelets, anticoagulants, thrombolytics, or anti-inflammatories.
• •Have an active localized or systemic infection.
• •Have an open wound in area being treated.
• •Have a significant systemic illness or an illness localized in area being treated.
• •Have had recent surgeries or problems in the treatment area (e.g. neck fracture, neck sprain, pinched nerve, spondylosis, arthritis in the neck).
• •Have a history of thrombophlebitis.
• •Have a history of heart failure or kidney disease.
• •Have a history of allergic reaction or intolerance to the anesthesia used during the procedure.
• •Have a history of poor wound healing.
• •Have a history of poor circulation.
• •Have a systemic autoimmune disease known to impair wound healing.
• •Have a history of keloid formation.
• •Currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.
• •Has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.