A Retrospective Chart Review of Subdermal Neck Coagulation using Helium Plasma Technology

ITEM TYPE:

Journal Article

AUTHORS:

Vaishali Doolabh, MD; Paul Ruff, MD

SUMMARY:

This journal article consisted of two separate retrospective chart review studies (Study 1, n=15 and Study 2, n= 13) performed using data from subjects who had undergone helium plasma treatment with Renuvion® for subdermal coagulation to achieve tissue contraction in the neck.

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. 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

  • Indications for Use – Subdermal Coagulation (All Territories):
    • 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 “neck rejuvenation”, “skin rejuvenation”, “skin laxity’, “skin contraction”, “treating lax & sagging skin”, 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].
    • 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.
  • Indications for Use – Dermal Resurfacing (All Territories except European Union):
    • The use of any of the Renuvion/J-Plasma devices for Dermal Resurfacing including the non-invasive treatment of facial wrinkles and rhytides or other cosmetic skin treatments in any territory outside of the EU is considered an off-label procedure (not supported by cleared labeling) unless approved by the corresponding territory registration.
    • The Renuvion system is intended to be used for the delivery of radiofrequency energy and/or a helium gas plasma for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures.
    • The use of the terms “dermal resurfacing” and “skin rejuvenation” in relation to the use of Renuvion/J- Plasma technology has not been cleared by the FDA and is currently being investigated under a different Investigational Device Exemption (IDE) study [clinicaltrials.gov identifier: NCT04185909].
  • Indications for Use – Dermal Resurfacing (European Union Only):
    • The Renuvion Dermal Handpiece is the only Handpiece model in the Renuvion portfolio of products that is intended to be used for the non-invasive treatment of facial wrinkles and rhytides in patients with Fitzpatrick skin types I, II or III. The system is not regulated in the EU as a medical device or a cosmetic product as facial wrinkles and rhytides are not classified as a disease and therefore, the system does not have a medical purpose.

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.

Risk associated with the use of Renuvion for dermal rejuvenation may include: unintended burns, temporary nerve injury, pain, tenderness, itching, bleeding, bruising/hematoma/seroma, allergic reaction, hypersensitivity to the treatment (resulting in erythema, swelling, induration and/or urticaria), temporary or permanent post-inflammatory hyperpigmentation, telangiectasias, skin overheating/burn, hypertrophic scarring, hypopigmentation, calcification, discoloration/permanent hypopigmentation, vessel laceration or occlusion, abscess (infection) at treatment site which may result in induration and/or scar formation, and prolonged wound healing. 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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