Thermal Effects of Percutaneous Application of Plasma/Radiofrequency Energy on Porcine Dermis and Fibroseptal Network

ITEM TYPE:

Journal Article

AUTHORS:

Paul G. Ruff, MD

SUMMARY:

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.

APYX® MEDICAL DISCLOSURES:

FINANCIAL & CONTENT DISCLOSURE
This research and the publication costs were funded in whole by Apyx Medical. Dr. Ruff is a Medical Advisory Board member, consultant, and clinical research investigator for Apyx Medical and receives compensation in the form of Apyx stock and hourly compensation. The opinions contained herein are those of the author 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 system is indicated for the delivery of helium plasma to cut coagulate and ablate soft tissue during open surgical procedures. The Apyx Plasma/RF Handpiece (APR HP) is intended to be used with compatible electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. The APR HP is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue.
  • The Renuvion/J-Plasma system has received a general clearance and has not been determined to be safe or effective for use in any specific indication or anatomical location.
  • Apyx Medical wants to present to you with current scientific discourse. Please be aware that the scientific discussion in the article goes beyond the general cleared use of cutting, coagulation, and ablation of soft tissue.
  • The use of the terms “neck rejuvenation”, “skin rejuvenation”, “reduce skin laxity’, “skin contraction”, “treat lax & sagging skin”, “treat submental and neck laxity”, ‘treat skin laxity”, and “skin tightening” in relation to the use of Renuvion/J-Plasma technology and the safety of the specific use of Renuvion technology for subdermal use in the neck/submental region has not been established or cleared by the FDA; an Investigational Device Exemption (IDE) study is currently underway to demonstrate safety and effectiveness [clinicaltrials.gov identifier: NCT04146467].

RISKS
Risk associated with the use of the Renuvion system for subdermal coagulation may include: unintended burns (deep or superficial), pneumothorax, scars, temporary or permanent nerve injury, pain, discomfort, gas buildup resulting in temporary and transient crepitus or pain, infection, hematoma, seroma; asymmetry and/or unacceptable cosmetic result. There may be additional risks associated with the use of other devices along with Renuvion and there may be an increased risk for patients who have undergone prior surgical or aesthetic procedures in the treatment area. 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.

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