The Use of Cold Atmospheric Plasma Device in Flap Elevation

ITEM TYPE:

Journal Article

AUTHORS:

Massimo Pinelli, MD; Marta Starnoni, MD; Giorgio De Santis, MD

SUMMARY:

This article shares the authors experiences using J-Plasma®/Renuvion® in flap elevation. The authors describe the technical advantages of J-Plasma when compared with conventional electrosurgical devices which include minimal lateral and depth of thermal spread, a high level of precision, and less smoke, odor, and eschar.

APYX® MEDICAL DISCLOSURES:

FINANCIAL DISCLOSURES
This journal article by Pinelli M, Starnoni M, and De Santis G was not supported by Apyx Medical, Inc. The opinions contained herein are those of the authors and do not necessarily represent the official position or policies of Apyx Medical. The author has no financial connection with Apyx Medical other than as a user of the technology.

MANUFACTURING DISCLOSURES
Apyx Medical manufactures and owns the J-Plasma/Renuvion technology discussed in this article.

CLEARED INDICATIONS & INTENDED USE DISCLOSURES

  • The J-Plasma 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 “skin rejuvenation” and “skin tightening” and “skin cancer treatment” in relation to the use of the J-Plasma/Renuvion technology has not been approved or cleared by the FDA.
  • The use of any of the J-Plasma/ Renuvion 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.
  • Apyx Medical wants to present you with current scientific discourse. Specific usage outside of the general cleared indication may not be safe or effective. J- Plasma/Renuvion has received a general clearance and has not been determined to be safe or effective for use in any specific indication or anatomical location.

RISKS
Risk associated with the use of the J-Plasma technology for open surgical procedures 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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