ITEM TYPE:
Journal Article
AUTHORS:
Keith Sweitzer MD, Zaidal Obagi MD, Tia Rahman MD, Peter F. Koltz MD, and Frank Barone MD
ABSTRACT:
Background: Helium gas passed through an electrically-charged retractable surgical blade creates cold-atmospheric plasma, which produces a precise, instantaneous thermal and electrophysiological effect involving rapid tissue heating and cooling. Such surgical devices have already been approved by the FDA for cutting, coagulation and ablation. They have also been studied for use on cutaneous diseases, such as superficial carcinomas and rhinophymas, due to their significant tissue-modifying effects. We present a case series using a helium laser for off-label use in skin rejuvenation and deep tissue contraction.
Objectives: The primary objective was to test the capability of a helium-based plasma device as a facial resurfacing tool and to document its beneficial and adverse effects.
Methods: Four patients of Fitzpatrick Skin Types II and III underwent facial resurfacing using a helium-based plasma device (Renuvion®) under either p.o sedation or general anesthesia. Platelet-rich plasma (PRP) was applied to three of the four patients after the procedure. Nanofat/fat injection was additionally performed on two of the patients (one with and one without PRP) during the procedure.
Results: Effective and deep skin rejuvenation was achieved using the helium device in all four patients. Deep rhytid effacement, pigment correction, and cutaneous tightening was dramatic and, in our experience, superior to comparable procedures, such as CO2 lasers or chemical peels. Skin tightening and elasticity improvement is most likely a result of subdermal and deep dermal remodeling from helium’s unique effects on dermal fibroblasts. Prolonged erythema was the most commonly seen complication.
Conclusion: We found helium-based facial resurfacing to be a safe and effective method for skin rejuvenation and deep tissue contraction. Further analysis with a larger power and continued long-term follow-up, alongside studies further investigating the mechanisms of ionized helium and prevention of prolonged erythema, are ongoing.
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).
- Renuvion Dermal Handpiece is indicated for dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II, or III.
- Apyx Medical wants to present to 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.
- Risks associated with the use of the Renuvion Dermal System include but are not limited to hypertrophic scarring, milia/acne, telangiectasia (spider veins), skin discoloration/ hypopigmentation, dormant infection reactivation, infection, bruising or bleeding. Warning: Application of more than one treatment pass in the perioral area, on the forehead, and along the jawline has been associated with hypertrophic scarring.
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.
