TAGS: Skin Care
Allergan has announced that it has received U.S. Food and Drug Administration (FDA) approval for the use of Juvéderm VOLUMA® XC via cannula for cheek augmentation to correct age-related volume deficit in the mid-face in adults over 21.
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Juvéderm VOLUMA® XC is a hyaluronic acid gel dermal filler with a TSK STERiGLIDE™ cannula.
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It has a thin, flexible tube with a rounded tip and serves as an efficient delivery system.
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TSK STERiGLIDE™ cannula can be used to inject Juvéderm VOLUMA® XC in the cheek area.
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It has a unique design compared to other cannulas.
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For precise product placement, it has a tip design with a near-tip delivery port.
Use of Cannula with Juvéderm VOLUMA® XC
Dr. Dee Anna Glaser, a board-certified dermatologist in St. Louis and clinical trial investigator 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."
Carrie Strom, Senior Vice President of U.S. Allergan Medical Aesthetics commented, “
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."
Study to Assess the Safety & Effectiveness
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A multicenter, split-face, investigator-blinded, non-inferiority study was performed on Juvéderm VOLUMA® XC for correction of age-related volume deficit in the mid-face with the use of a TSK STERiGLIDE™ cannula versus a needle to test its safety.
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The 12-week study took place in seven sites across the U.S. with 60 subjects.
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All subjects completed the study.
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Results demonstrated comparable performance, safety profile and patient satisfaction between cannula and needle injection.
This is the first approval for the use of cannula within the Juvéderm Collection of Fillers.
Juvéderm VOLUMA® XC was first approved by the FDA in 2013. It is formulated with Allergan's proprietary VYCROSS® technology, blends with different molecular weights of hyaluronic acid, contributing to the gel's duration and is proven to last in the mid-face area for up to 24 months with optimal treatment.
Source: Allergan