Thermal Effect of J-Plasma® Energy in a Porcine Tissue Model: Implications for Minimally Invasive Surgery

ITEM TYPE:

Journal Article

AUTHORS:

Pedroso JD, Gutierrez MM, Volker W, Howard DL

SUMMARY:

To evaluate tissue effect of Renuvion®/J-Plasma in porcine liver, kidney, muscle, ovarian, and uterine tissue blocks. Renuvion/J-Plasma did not exceed 2mm thermal spread on liver, kidney, muscle, ovarian, and uterine tissue, even at maximum settings of 100% power and 5 L/min gas flow after five seconds. The Renuvion/J-Plasma helium device has minimal lateral and depth of thermal spread in a variety of tissue types

APYX® MEDICAL DISCLOSURES:

FINANCIAL DISCLOSURES (at time of publication)
Dr. Gutierrez is a paid consultant with Apyx Medical Corporation, previously Bovie® Medical Corporation.

All other authors have no financial interests to disclose. None of the authors have received any compensation from the manufacturer of the device presented in the preparation of this manuscript.

CLEARED INDICATIONS & MANUFACTURING DISCLOSURES

  • 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.
  • 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 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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