Calcium hydroxylapatite (Radiesse) for treatment of nasolabial ... | 合法醫療器材資訊網

由LSBass著作·2010·被引用108次—Background:Calciumhydroxylapatite(CaHA,Radiesse)isapprovedbytheFoodandDrugAdministrationfortreatmentofmoderatetoseverewrinklesandfolds ...

Background: Calcium hydroxylapatite (CaHA, Radiesse) is approved by the Food and Drug Administration for treatment of moderate to severe wrinkles and folds, including nasolabial folds (NLF). A pivotal NLF split-face study previously compared the performance of Radiesse to human-based collagen at six months and safety of Radiesse through one year.

Objective: The authors assess the long-term safety and effectiveness of Radiesse for the treatment of NLF. Postapproval long-term results now extend to more than three years and are presented here.

Methods: This study reports an extension phase of a previously reported one-year premarket study of 117 patients comparing Radiesse to collagen. During the initial study, patients were treated to optimal correction and then followed for 12 months; they were offered retreatment with Radiesse between six and 12 months in both folds to balance asymm...