Green, MD, of Skin Associates of South Florida/Skin Research Institute. “A sagging jawline is a primary indicator of facial aging, and I regularly treat women and men who seek a well-contoured jawline for a more defined profile,” said Jeremy B. Radiesse (+) is also approved for moderate to severe lower face wrinkles and folds, and the new indication brings the unique properties of CaHA to jawline treatment. The first product in the portfolio, Radiesse, is an injectable biostimulator indicated for correction of moderate to severe lower face wrinkles and folds and for the improvement of volume loss in the dorsum of the hands. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics.ĬaHA is a unique category in the marketplace, with properties shown to provide immediate improvement as well as long-term results due to stimulation of collagen and elastin production (up to a year in most patients) in lower face wrinkles and folds. This approval provides our customers and their patients a non-surgical, effective and safe option to address loss of jawline contour,” said Dr. “The jawline is an important structural component of the face and has a profound effect on an individual’s appearance. Food and Drug Administration (FDA) approved the supplemental Premarket Approval Application (sPMA) in September 2021. Radiesse Injectables represent the first and only calcium hydroxylapatite (CaHA) portfolio in the U.S., and Radiesse (+) is the first and only FDA-approved injectable treatment for jawline contour improvement. doi:10.36849/, N.C.-( BUSINESS WIRE)-Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced today the commercial launch of Radiesse ® (+) Lidocaine injectable implant for deep injection (subdermal and/or supraperiosteal) for soft tissue augmentation to improve moderate to severe loss of jawline contour in adults over the age of 21. The study demonstrated a favorable safety profile, with no reported unexpected adverse events.ĬaHA (+) is a safe and effective treatment for improving the contour of the jawline. A total of 76/113 (67.3%) patients who responded to treatment 12 weeks after initial injection also demonstrated persistent improvement 48 weeks after initial treatment. Satisfaction with aesthetic improvement was reported by patients and treating investigators throughout the study. The difference between response rates was statistically significant (P<0.0001), showing superiority of treatment over control. Treatment response rate (≥1-point MJAS improvement) was 93/123 (75.6%) for the treatment group and 5/57 (8.8%) for the control/delayed-treatment group at week 12. Adverse events were recorded over a 60-week period. Effectiveness was evaluated on the MJAS, patient and investigator Global Aesthetic Improvement Scales, and FACE-Q™ questionnaires. Touch-ups were allowed in both groups, and re-treatment was allowed in the treatment group only. Patients in the control group remained untreated until week 12, then received delayed treatment. Healthy eligible patients with moderate or severe ratings on the Merz Jawline Assessment Scale (MJAS) were randomized 2:1 to treatment with CaHA (+) or to control. To demonstrate the effectiveness and safety of calcium hydroxylapatite with lidocaine to improve the contour of jawline after deep (subdermal and/or supraperiosteal) injection. Not all cases require surgical intervention and soft-tissue augmentation with injectable fillers may restore the profile and youthful appearance of the jawline. One of the early signs of aging is loss of jawline contour.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |