Utilization of Low-Temperature Helium Plasma (J-Plasma®) for Dissection and Hemostasis During Carotid Endarterectomy

ITEM TYPE:

Journal Article

AUTHORS:

Konstantinos Filis, PhD, George Galyfos, PhD, Fragiska Sigala, PhD, and Georgios Zografos, PhD

SUMMARY:

Herein we report nine cases of carotid endarterectomy in which we used a cold atmospheric helium plasma device (J-Plasma). Although clinical reports are limited, experimental data indicate that this technology could be used for dissection and coagulation during surgery, yielding limited adjacent tissue damage. As a result, it could be extremely useful in procedures like carotid endarterectomy that necessitate careful dissection and coagulation with limited damage of adjacent neurovascular structures.

APYX® MEDICAL DISCLOSURES:

FINANCIAL DISCLOSURES (at time of publication)
This literature by Konstantinos Filis, PhD, George Galyfos, PhD, Fragiska Sigala, PhD, and Georgios Zografos, PhD 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 author has no financial connection with Apyx Medical, Inc. other than as a user of the technology. Apyx Medical did pay $500 for publication of the 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 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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