Safety and efficacy of helium plasma for subdermal coagulation

ITEM TYPE:

Journal Article

AUTHORS:

Paul G. Ruff IV, MD; Vaishali Doolabh, MD; Edward M. Zimmerman, MD; Richard A. Gentile, MD, MBA

ABSTRACT:

Background: Surgical and nonsurgical treatments or procedures are often combined to achieve desired aesthetic results. A novel helium‐based plasma device has recently been developed to briefly heat soft tissue which coagulates collagen and achieves additional tissue contraction through neocollagenesis and tissue remodeling. Two chart reviews were performed on patients who had undergone liposuction combined with helium plasma treatment.

Objectives: The primary objective was to evaluate the safety of these combined procedures. Secondary objectives were to assess aesthetic improvements and overall subject satisfaction.

Methods: Both studies retrospectively reviewed medical records for adult subjects undergoing a subdermal coagulation procedure with the helium plasma device following liposuction. One review included pre‐ and posttreatment subject images and subject satisfaction.

Results: Study 1 identified 37 subjects who were male (n = 6) and female (n = 31), 21–70‐years old with a mean body mass index (BMI) of 27 kg/m2 (range, 18–41 kg/m2). Study 2 identified 148 eligible subjects. Most subjects were female (n = 120), 21–84‐years old with a mean BMI of 27 kg/m2 (range, 18–44 kg/m2). Mean plasma generator settings were 70% power, mean helium flow was 3 L/min with four to six passes per area. Among subjects with efficacy data, most subjects (77%) reported aesthetic improvement and were happy with their results, would recommend to a friend, and would consider having their procedure repeated (68%). Overall satisfaction was achieved by 74%.

Conclusions: These results suggest helium plasma is a safe and effective adjunct therapy when used in combination with liposuction.

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.