FDA approves Juvederm VOLUMA XC, a hyaluronic acid gel dermal filler, with a TSK STERiGLIDE cannula for cheek augmentation.-Allergan/AbbVie

Allergan plc announced it received FDA approval for the use of Juvederm VOLUMA XC, a hyaluronic acid gel dermal filler, with a TSK STERiGLIDE cannula for cheek augmentation to correct age-related volume deficit in the mid-face in adults over 21. A cannula is a thin, flexible tube with a rounded tip that can serve as an effective delivery system. Use of a cannula allows for injection of Juvederm VOLUMA XC in the cheek area. The TSK STERiGLIDE has a unique design compared to other cannulas available on the market and features a patented tip design with a near-tip delivery port for precise product placement.

A multicenter, split-face, investigator-blinded, non-inferiority study was performed to assess the safety and effectiveness of Juvederm VOLUMA XC for correction of age-related volume deficit in the mid-face with the use of a TSK STERiGLIDE cannula versus a needle. The 12-week study took place in seven sites across the U.S. with 60 subjects. All subjects completed the study. Results demonstrated comparable performance, safety profile and patient satisfaction between cannula and needle injection.