Delivery System Approved for Cheek Injection of Dermal Filler
The gel product, which was first approved by the FDA in 2013, is intended for cheek augmentation to correct age-related volume deficit in the mid-face in adults over age 21 years.
Officials with the FDA have approved mid-face injection of hyaluronic acid gel dermal filler (Juvéderm Voluma XC, Allergan) with a cannula (Steriglide, TSK), according to Allergan.
The gel product, which was first approved by the FDA in 2013, is intended for cheek augmentation to correct age-related volume deficit in the mid-face in adults over age 21 years.
The new use of a cannula— a thin, flexible tube with a rounded tip—to inject this dermal filler provides another treatment option for physicians and patients.
A multicenter, split-face, investigator-blinded, noninferiority study was performed to assess the safety and effectiveness of Allergan’s hyaluronic acid gel dermal filler in the mid-face with the use of a TSK’s cannula versus use of a needle as a delivery system.
The 12-week study took place in 7 sites across the United States with 60 subjects. All subjects completed the study. Results demonstrated comparable performance, safety profile and patient satisfaction between cannula and needle injection.
Reference
Allergan Receives FDA Approval of Juvéderm VOLUMA® XC For Mid-Face Injection Via Cannula [news release]. Dublin, Ireland; September 3, 2019: Allergan website. https://www.allergan.com/news/news/thomson-reuters/allergan-receives-fda-approval-of-juv-derm-voluma.aspx. Accessed September 3, 2019.
