Allergan’s Juvéderm Voluma XC is now U.S. Food and Drug Administration (FDA)-approved for cheek augmentation in the mid-face in adults over 21 with a TSK Steriglide cannula.
This cannula features a patented tip design with a near-tip delivery port for precise product placement. Within the Juvéderm Collection of Fillers, this is the first approval for the use of cannula.
"As a physician, I have used the Juvéderm Collection of Fillers for 13 years, so I am thrilled that the FDA has approved the use of cannula with Juvéderm Voluma XC for mid-face volume deficit. With this latest approval, I have another effective option to provide volume and contour in the mid-face area. I can tailor my treatment approach for each patient while safely providing the aesthetic outcomes they wish to achieve," says Dee Anna Glaser, MD a dermatologist in St. Louis and clinical trial investigator, in a news release."At Allergan, we are committed to driving innovation in medical aesthetics as well as providing best-in-class injector training to our customers," says Carrie Strom, Senior Vice President of U.S. Allergan Medical Aesthetics. "With this approval, Allergan will be able to educate on facial anatomy and injection techniques that will help healthcare providers administer treatment with Juvéderm Voluma XC safely to achieve optimal patient satisfaction."
A multicenter, split-face, investigator-blinded, non-inferiority study was performed to assess the safety and effectiveness of Juvéderm Voluma XC for correction of age-related volume deficit in the mid-face with the use of the new 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.