The Juvéderm VOLUMA XC is designed to be used with a TSK STERiGLIDE cannula for cheek augmentation to correct age-related volume deficit in the mid-face
Allergan announced that the US Food and Drug Administration (FDA) has approved the use of its Juvéderm VOLUMA XC, a hyaluronic acid gel dermal filler, with a TSK STERiGLIDE cannula.
The Juvéderm VOLUMA XC is indicated for use with a TSK STERiGLIDE cannula for cheek augmentation to correct age-related volume deficit in the mid-face in adults over 21.
Allergan Medical Aesthetics US senior vice president Carrie Strom said: “At Allergan, we are committed to driving innovation in medical aesthetics as well as providing best-in-class injector training to our customers.
“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 cannula is a thin, flexible tube with a rounded tip, used as a delivery system
Juvéderm VOLUMA XC is intended to be injected in the cheek area, using a cannula. The TSK STERiGLIDE cannula features a patented tip design with a near-tip delivery port for precise product placement.
The company said that the present FDA approval marks the first approval within the Juvéderm platform of fillers for use with cannula.
First approved by the FDA in 2013, Juvéderm VOLUMA XC was formulated with the company’s VYCROSS technology that combines different molecular weights of hyaluronic acid, which lasts for up to 24 months with optimal treatment in the mid-face area.
Allergan said that a multicentre, split-face, investigator-blinded, non-inferiority study was performed to evaluate the safety and effectiveness of Juvéderm VOLUMA XC in correcting age-related volume deficit in the mid-face, used with a TSK STERiGLIDE cannula versus a needle.
The 12-week study enrolled 60 subjects in seven sites across the US, and the study results showed comparable performance, safety profile and patient satisfaction between cannula and needle injection.
Clinical trial investigator Dee Anna Glaser said: “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.”