ITEM TYPE:

Journal Article

AUTHORS:

Paul Ruff, MD, Paul Vanek, MD, Matthew Nykiel, MD

ABSTRACT:

Background: Protein denaturation and collagen contraction occur when living tissue is heated to well-defined temperatures. The result is reduced volume and surface area of the heated tissue.

Objective: To evaluate the adverse events of procedures in which a helium-based plasma technology was used with and without ultrasound-assisted liposuction for the coagulation of soft tissue.

Methods: A multicenter retrospective chart review was performed in which patients (n=192) were divided into two groups: one that received only soft tissue coagulation and the other that received both soft-tissue coagulation and liposuction. Each of the two groups was subdivided into patients with and without adverse events, including seroma. Odds ratios for adverse events were calculated for both demographic and surgical subgroups. Seroma data were analyzed separately.

Results: No serious adverse events were observed. Forty-six (24.0%) patients reported 51 total adverse events. Seroma was the most frequently occurring adverse event with 13 patients (6.8%) reporting 17 (33.3%) events in 12 body areas. In these cases, all areas were treated with both liposuction and soft tissue coagulation. Seroma was not observed in patients receiving soft tissue coagulation alone. Patients aged 61 to 76 years and males were more likely to experience seroma or other adverse event than younger patients or females, respectively.

Conclusions: The use of the helium-based plasma technology for soft tissue coagulation in combination with ultrasound for liposuction is associated with non-serious adverse events. The most frequently occurring adverse event, seroma, was not observed in patients treated with helium-based plasma technology alone.

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.