The U.S. Food and Drug Administration (FDA) has cleared Candela’s Matrix system for the percutaneous treatment of facial wrinkles in patients with Fitzpatrick Skin Types (FST) I-IV using its Matrix Pro RF microneedling applicator.
The applicator was previously FDA-cleared for use in general dermatological procedures involving hemostasis and electrocoagulation.
The Matrix multi-application RF skin platform is equipped with Sublime, Sublative, and Matrix Pro applicators. The Matrix Pro applicator is the only RF microneedling solution FDA-cleared for percutaneous facial wrinkles that uses an advanced algorithm to continuously measure tissue impedance and make necessary adjustments to pulse duration and power output, preventing unintentional fat loss or other undesirable results.
FDA clearance for the new indication is based on retrospective study data of 32 subjects receiving full-face treatments with the Matrix Pro applicator for facial wrinkle reduction. The study demonstrated a clinically meaningful improvement in facial wrinkle appearance based on blinded evaluation of treatment photos. Additionally, 94% of study subjects rated their treatment outcomes as ‘much improved’ or ‘very much improved.
“This clearance provides healthcare providers and their patients with a reliable, clinically validated treatment option for facial wrinkles,” says Geoffrey Crouse, Candela’s Chief Executive Officer, in a news release. “Our Matrix Pro applicator with its expanded facial wrinkle indication, further combined with the unique treatment capabilities of the Sublime and Sublative applicators, exemplifies our unique approach, integrating state-of-the-art research and development of multi-modality solutions to deliver superior results.”
