Clinical References

Helium Plasma-Driven Radiofrequency in Body Contouring

ITEM TYPE:

Book Chapter

AUTHOR:

Diane I Duncan, MD

SUMMARY:

Monopolar and bipolar radiofrequency-based devices have been available for 10 years. Recently, a plasma-driven radiofrequency device, Renuvion, was introduced for soft tissue coagulation. The device uses a pressurized helium tank to drive radiofrequency energy into a hollow cannula. As measured skin temperature rarely exceeds 38°C, the safety profile of the device is optimized.

APYX MEDICAL DISCLOSURES:

FINANCIAL DISCLOSURES
Diane Duncan is a Medical Advisory Board member, consultant, and grant recipient with Apyx Medical and receives compensation in the form of Apyx stock and hourly compensation. Diane Duncan has not received any compensation for this article outside of the submission fee to IntechOpen for this publication in the amount of £1,400 GBP.

CLEARED INDICATIONS & MANUFACTURING DISCLOSURES

  • The use of the terms “body contouring” in relation to the use of the Renuvion®/J‑Plasma® technology has not been approved or cleared by the FDA.
  • Apyx Medical wants to present you with current scientific discourse. Specific usage outside of the general cleared indication may not be safe or effective. Renuvion/J- Plasma has received a general clearance and has not been determined to be safe or effective for use in any specific indication or anatomical location including skin tightening indication referenced in this article.
  • Apyx Medical manufactures and owns the Renuvion/J-Plasma technology discussed in this article.

RISKS
Risk associated with the use of the Renuvion technology 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.

INTENDED USE DISCLOSURE
The Renuvion/J-Plasma Precise Open® Handpiece is intended to be used with compatible J-Plasma 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 Renuvion/J-Plasma Precise & Precise Open Handpieces are compatible with electrosurgical Generators BVX-200H, and BVX-200P. Refer to the Instructions for Use for the currently approved or cleared indications.

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