ITEM TYPE:

Journal Article

AUTHORS:

Vaishali Doolabh, MD; Paul Ruff, MD

ABSTRACT:

Background: A helium‐based plasma technology has recently been cleared by the Food and Drug Administration for cutting, coagulation, and ablation of soft tissue (Renuvion® System; Apyx® Medical Corporation). As the safety of helium plasma for treating lax and sagging skin in the neck area has not been previously reported, the objectives of this study were to obtain safety results from helium plasma used for neck rejuvenation, to summarize subject and procedure variables, and to assess treatment outcomes for the development of future treatment protocols.

Methods: Two retrospective chart reviews were performed using data from patients who had undergone a helium plasma procedure in the neck area to assess safety (Study 1) and effect (Study 2). For Study 2, pre‐ and posttreatment images of treatment areas were assessed by blinded reviewers.

Results: In Study 1 (N = 15), two adverse events felt to be treatment‐related were noted. In Study 2 (N = 13), mean improvements included a 37.29% reduction in submental angle and reduction in the submental area.

Conclusions: Helium plasma technology appears to be a safe and well‐tolerated treatment. Consistent and reproducible tissue contraction in the submental and neck area was observed between the authors’ sites.

APYX® MEDICAL DISCLOSURES:

FINANCIAL & CONTENT DISCLOSURE
The authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article. No funding was received for this article. Drs DiBernardo, Bharti, and Kortesis are paid consultants for Apyx Medical, and Dr Duncan is a member of Apyx Medical’s Medical Advisory Board. The opinions contained herein are those of the authors and do not necessarily represent the official position or policies of Apyx Medical, Inc.

MANUFACTURING DISCLOSURE
Apyx Medical manufactures and owns the Renuvion®/J-Plasma® technology discussed in this article.

INDICATIONS FOR USE & INTENDED USE DISCLOSURES

• • 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 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 to be used with compatible electrosurgical generators owned by Apyx Medical (specifically BVX-200H, BVX-200P, APYX-200H, APYX-200P, APYX-RS3, and APYX-JS3).
  • Apyx Medical wants to present you with current scientific discourse. Specific usage outside of the cleared indications may not be safe or effective.
  • The use of Renuvion with liposuction has not been approved or cleared by the FDA.

RISKS

• • 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.

As with any procedure, individual results may vary. As with all energy devices there are inherent risks associated with its use, refer to the IFU for further information.