ITEM TYPE:

Journal Article

AUTHORS:

Diane Irvine Duncan MD, FACS, and Shawn Roman

ABSTRACT:

Background and Purpose: The principle of thermally-induced contraction of collagen through denaturation and coagulation of soft tissue is well known in medicine and is used to achieve beneficial results in ophthalmology, orthopedics, varicose vein ablation, and cosmetic plastic surgery procedures. Once tissue is heated to the appropriate temperature, protein denaturation and collagen contraction occur resulting in a reduction of volume and surface area of the heated tissue. Recently, a helium-based plasma technology has been introduced for the percutaneous delivery of plasma energy for the purpose of soft tissue coagulation and contraction. The purpose of this research was to understand the internal and external tissue temperatures resulting from treatment with the helium plasma device and the impact of device settings on temperature during the coagulation and contraction of subcutaneous soft tissue.

Methods: Simulated use of the helium plasma device was performed on the abdomen of a live domestic cross pig following Klein solution infiltration and liposuction. Incisions through the epidermis and into the subcutaneous tissue plane were used as visualization windows to allow a FLIR camera to capture internal and external tissue temperatures simultaneously during activation. Internal and external tissue temperatures were recorded for various power and helium gas flow settings.

Results: For all but one treatment combination, the external tissue temperatures did not increase more than 3.6°C from baseline over the course of six treatment passes. Maximum internal tissue temperatures for 60% and 80% power settings exceeded 85°C for approximately 0.08 seconds while maximum temperatures for 40% power settings remained below 85°C.

Conclusions: Helium plasma power settings between 60% and 80% produce soft tissue coagulation and contraction by rapidly heating the treatment site to temperatures greater than 85°C for approximately 0.08 seconds. A power setting of 40% does not heat the tissue above 85°C and therefore is not adequate for soft tissue contraction at typical treatment speeds of 1cm/s used in a clinical setting. There were no distinguishable trends between the helium flow rate setting and internal and external tissue temperatures.

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.