Efficacy of a Novel Prefilled, Single-Use, Needle-Free Device (Zeneo®) in Achieving Intramuscular Agent Delivery: An Observational Study

Abstract : It is recognized that, as a result of variation in tissue anatomy, current auto-injectors may have insufficient needle length to achieve successful intramuscular agent delivery in a number of patients. The Zeneo(A (R)) auto-injector is a novel prefilled, single-use, needle-free device currently in development for intradermal, subcutaneous, and intramuscular agent delivery across a variety of clinical indications. We aimed to evaluate delivery depth of the device calibrated at pressure appropriate for intramuscular (IM) administration. This was a prospective single-center study in healthy adult volunteers, in whom each received a single injection of saline into the anterolateral thigh. Using sequential MRI scans, we measured skin-to-muscle distance (STMD) agent delivery depth, and the success of IM agent penetration. Device dynamic pressure measurements were also recorded. Results are reported for 37 subjects with evaluable MRI scans; 19 men, 18 women; mean age 38 years (range 20-58); mean BMI 27.0 kg/m(2) (range 21.2-30.8 kg/m(2)). Mean STMD values were 18.6 mm (range 13.4-23.6 mm) in women and 10.0 mm (range 5.0-21.7 mm) in men, with gender differences due primarily to greater subcutaneous thickness in women. A trend for greater STMD in subjects with BMI greater than 25 kg/m(2) was seen. Mean injectate penetration depths of 30.1 mm (range 20.2-45.6 mm) were observed with values similar in male and female subjects. Successful IM delivery was reported in 95% of subjects. When failure occurred, this was not due to inadequate injection depth. Device pressure (P (max)) had the greatest influence on injectate muscle penetration. Use of the Zeneo(A (R)) auto-injector achieves delivery depth that ensures intramuscular delivery in both men and women, regardless of BMI. Consistent with other reported data, STMD is greater in women. Crossject.
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https://hal-univ-bourgogne.archives-ouvertes.fr/hal-01469948
Contributeur : Le2i - Université de Bourgogne <>
Soumis le : jeudi 16 février 2017 - 19:51:11
Dernière modification le : mercredi 12 septembre 2018 - 01:27:25

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Marc Bardou, Maxime Luu, Paul Walker, Christophe Auriel, Xavière Castano. Efficacy of a Novel Prefilled, Single-Use, Needle-Free Device (Zeneo®) in Achieving Intramuscular Agent Delivery: An Observational Study. Advances in Therapy, Springer Verlag (Germany), 2017, 34 (1), pp.252 - 260. ⟨http://link.springer.com/article/10.1007/s12325-016-0452-0⟩. ⟨10.1007/s12325-016-0452-0⟩. ⟨hal-01469948⟩

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