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

SUMMARY:

This journal article consisted of two separate retrospective chart review studies (Study 1, n= 37 and Study 2, n= 148) performed using data from subjects who had undergone liposuction followed by subdermal coagulation using Renuvion®. Subjects were treated in a variety of anatomical areas, such as the abdomen, arms, and neck.

APYX® MEDICAL DISCLOSURES:

FINANCIAL & CONTENT DISCLOSURE
This research and the publication costs were funded in whole by Apyx Medical. Drs. Ruff, Zimmerman, and Gentile are Medical Advisory Board members, consultants, and clinical research investigators for Apyx Medical and receive compensation in the form of Apyx stock and hourly compensation. Dr. Doolabh is a paid consultant and clinical investigator for Apyx Medical. 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.
  • The use of the terms “energy-based rejuvenation”, “skin tightening”, “treating skin redundancy”, “treating skin laxity’, “treating chin sagginess”, “treating lax & sagging skin”, “arm tightening”, “improve the appearance of lax skin” and “aesthetic improvement” in relation to the use of Renuvion/J-Plasma technology and the safety of the specific use of Renuvion technology for subdermal use in any specific anatomical location has not been established or cleared by the FDA; an Investigational Device Exemption (IDE) study is currently underway to demonstrate safety and effectiveness in the neck/submental region [clinicaltrials.gov identifier: NCT04146467].
  • 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.

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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