Preliminary Experience in the use of J-Plasma® Device in Gynecological Malignancies

ITEM TYPE:

Poster

AUTHORS:

Alletti SG, Rosati A, Capozzi VA, Constantini B, Vizzielli G, Fagotti A, Fanfani F, Fedele C, Cianci S, Scambia G

SUMMARY:

The present study investigated the role of this novel plasma energy device in gynecological malignancies in the context of a modern personalized approach delivered by a tertiary care referral center. The setting of the device used was Coagulation 45, Cut 45, Bipolar Macro 1, J-Plasma Power 40%, Gas Flow 4.0 l/min, Pulsing 80. All patients showed peritoneal/serosal carcinomatosis with an indication of regional peritonectomy and/or ablation respectively.The use of J-Plasma in the laparoscopic or laparotomic cytoreductive surgery could enhance the removal of peritoneal and serosal carcinomatosis.

APYX® MEDICAL DISCLOSURES:

FINANCIAL DISCLOSURES (at time of publication)
This poster by S. Gueli Alletti, A. Rosati, V.A. Capozzi, B. Constantini, G. Vizzielle, A. Fagotti, F. Fanfani, C. Fedele, S. Cianci, G. Scambia was not supported by Apyx Medical, Inc. The opinions contained herein are those of the authors(s) and do not necessarily represent the official position or policies of Apyx Medical, Inc. The authors have no financial connection with Apyx Medical, Inc. other than as a purchaser/user of the technology.

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 or anatomical location.
  • Apyx Medical manufactures and owns the Renuvion/J-Plasma technology discussed in this article.

RISKS
Risks associated with the use of J-Plasma may include: Helium embolism due to insufflation of gas into the surgical site or due to inadvertent introduction into the venous or arterial blood supply system; ineffective hemostasis; infection of the treatment site post-treatment; unintended injury (burn, scarring, increased healing time) due to excessive treatment; pneumothorax, hematoma, pain, erythema, edema, or bleeding. 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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