A Post-Market Study in Greece of a Minimally Invasive Breast Lift Procedure Utilizing the Renuvion APR System

Inclusion Criteria

• Female subjects, ages 18 - 75 years old.
• ASA Physical Status Classification System Class I and Class II subjects.
• Breast Ptosis Class II and Class III as per the Eyck et al, Rainbow Scale for Assessing Breast Ptosis.
• Breast Cup Size A and Size B.
• Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation.
• Absence of physical conditions unacceptable to the investigator.
• Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
• Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.
• Willing to release rights for the use of study photos, including in publication.
• Able to read, understand, sign, and date the informed consent.
• Able to communicate with the site via video and/or photographs, in the event of a virtual follow-up visit.

Exclusion Criteria

• Subjects presenting with ASA Physical Status Classification System Classes III or higher.
• Breast ptosis Class IV or more as per the Eyck et al, Rainbow Scale for Assessing Breast Ptosis.
• Breast Cup Size C, Size D or larger.
• Prior surgery or procedure in the breast area (i.e., implants, skin tightening procedures, breast reduction, etc.).
• Pregnant, lactating, or plans to become pregnant during study participation.
• Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine).
• Known hypersensitivity or allergy to ibuprofen or other NSAIDS.
• Previous treatment in the study treatment area.
• Active systemic or local skin disease that may alter wound healing.
• Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health.
• History of autoimmune disease (excluding Hashimoto's thyroiditis).
• Known susceptibility to keloid formation or hypertrophic scarring.
• Cancerous or pre-cancerous lesions in the area to be treated.
• Possesses a surgically implanted electronic device (i.e., pacemaker).
• Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
• Participation in any other investigational study within 30 days prior to consent and throughout study participation.
• Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.