Safety and efficacy of a continuous-flow, injection-assisted device in delivery of dermal fillers.

[BACKGROUND] A device to assist in the delivery of dermal filler may achieve reductions in patient discomfort and adverse events, as well physician fatigue. It may also increase the accuracy of material placement.

[OBJECTIVES] The authors assess the safety and performance of the Artiste Assisted Injection System (Nordson Micromedics, St Paul, Minnesota) in normal therapeutic use compared with the standard manual administration of dermal fillers.

[METHODS] At 3 study sites, a total of 52 patients (48 women and 4 men) received bilateral full-correction injections of dermal fillers into randomized nasolabial folds (NLF). Injection into 1 NLF was made via Artiste, and injection into the other NLF was made via manual delivery. Immediately posttreatment and through 29 days, physician investigators, patients, and blinded evaluators recorded treatment durations and volumes, evaluated designated posttreatment characteristics using questionnaires, and documented adverse events (AE) and differences in cosmetic effects.

[RESULTS] Mean filler volume was 1.25 mL for the Artiste-treated NLF and 1.29 mL for manually treated NLF. One investigator used significantly less volume with Artiste than with manual injection (0.95 mL vs 1.12 mL; P = .001). Blinded evaluators rated Wrinkle Severity Rating Scale (WSRS) results as "identical" in 81% of patients. Investigator questionnaires showed a clear and statistically significant preference for Artiste over manual injection in all parameters (P < .001).

[CONCLUSIONS] The Artiste device is a viable option for physicians seeking a continuous-flow, injection-assisted device for ease of treatment, better accuracy, and improved results.