The Renuvion APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue. The Renuvion APR Handpiece is intended for the coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring. The Renuvion APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region. The Renuvion APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. The Renuvion APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical. Not all indications are approved in all markets; check with your local sales representative for further information.
As with any aesthetic procedure, individual results may vary. As with all energy devices there are inherent risks associated with its use. Risk associated with the use of the Renuvion APR may include: helium embolism into the surgical site due to inadvertent introduction into the venous or arterial blood supply system, unintended burns (deep or superficial), pneumothorax, temporary or permanent nerve injury, ischemia, fibrosis, infection, pain, discomfort, gas buildup resulting in temporary and transient crepitus or pain, bleeding, hematoma, seroma, subcutaneous induration, pigmentation changes, increased healing time, scarring, asymmetry and/ or unacceptable cosmetic result. Please see the instructions for use for more detailed information.
- FDA 510(k) Premarket Notifications K230272 & K223262.https://www.clinicaltrials.gov/ct2/results?term=NCT04146467.
- ISAPS International Survey on Aesthetic/Cosmetic Procedures 2021. https://www.isaps.org/media/vdpdanke/isaps-global-survey_2021.pdf
- Feldman LS, et al. (eds). The SAGES Manual on the Fundamental Use of Surgical Energy (FUSE), ISBN 978‐1‐4614‐2073‐
- Chen SS, Wright NT, Humphrey JD. Heat-induced changes in the mechanics of a collagenous tissue: isothermal free shrinkage. Journal of Biomechanical Engineering 1997:109:372-378.
- McDonald MB. Conductive Keratoplasty: A Radiofrequency-based Technique for the Correction of Hyperopia. Trans Am Ophthalmol Soc 2005;103:512-536.
- Chen SS, Humphrey JD. Heat-induced changes in the mechanics of a collagenous tissue: pseudoelastic behavior at 37° C. J Biomech 1998;31:211-216.
- Wright NT, Humphrey JD. Denaturation of collagen during heating: An irreversible rate process. Annu Rev Biomed Eng; 2002;4:109-128.
- Masghati S, Pedroso J, Gutierrez M, Stockwell E, Volker W, Howard DL. Comparative Thermal Effects of J-Plasma®, Monopolar, Argon, and Laser Electrosurgery in a Porcine Tissue Model. Surgical Technology International, 2019;34:1-5. PMID: 30825320.
- Duncan DI and Roman S. Helium Plasma Subdermal Tissue Contraction Method of Action. Biomed J Sci & Tech Res 31(2)-2020. BJSTR. MS.ID.005075.
- Renuvion Physician Survey Results, MM0317.01 0422 – https://www.renuvion.org/wp-content/uploads/2022/05/renuvion-physician-survey-results-brochure_mm0317.01_050222.pdf.
- Ruff PG, Doolabh V, Zimmerman EM, Gentile RA. Safety and efficacy of helium plasma for subdermal coagulation. Dermatological Reviews. 2020;1-7. https://doi.org/10.1002/der2.34.