ITEM TYPE:

Journal Article

AUTHORS:

Paul G. Ruff IV, MD, FACS

ABSTRACT:

Background: Skin laxity is one of the defining characteristics of aging and can be the result of various factors including intrinsic aging, genetics, diet, stress, lifestyle, sun exposure, weight fluctuations, and smoking. Recent reports suggest the ability of subdermal energy application to reduce skin laxity. Thermal energy can be delivered using different devices including lasers, radiofrequency (RF) monopolar and bipolar devices, and plasma/RF devices. Plasma-based energy platforms generate a plasma gas, allowing heat to be applied to the tissue. This study focused on the evaluation of thermal effect of plasma/RF compared to a monopolar RF device applied percutaneously to the subdermis and connective fibroseptal network in a porcine model.

Methods: The subdermal application of energy was conducted using a plasma/RF system and a monopolar RF system. Both low and high energy/temperature settings were evaluated in dynamic and stationary modes. Histomorphometry was used to determine the depth of thermal effect associated with each treatment setting.

Results: Both dermis and fibroseptal network tissue exhibited the presence of microscopically thermally treated zones. There were no significant differences in average and maximum depths of thermal effect between the different handpieces and electrosurgical systems used for all treatment settings.

Conclusions: No significant differences in the thermal effect between plasma/RF and monopolar RF systems were observed, suggesting that plasma/RF systems can be safely used for the percutaneous application of energy in the subcutaneous space.

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.