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

ABSTRACT:

Herein we report nine cases of carotid endarterectomy in which we used a cold atmospheric helium plasma device (J-Plasma; Apyx Medical Corporation, Clearwater, Fla). 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 & CONTENT DISCLOSURE
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.

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

INDICATIONS FOR USE & INTENDED USE DISCLOSURES

• The Renuvion Precise, Precise Open, and J-Plasma Handpieces are intended to be used with compatible electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation, and ablation of soft tissue during open surgical procedures.
• Apyx Medical wants to present to you with current scientific discourse.

RISKS

• Risk associated with the use of the device may include: Helium embolism into the surgical site due to inadvertent introduction into the venous or arterial blood supply system, unintended burns (deep or superficial), pneumothorax, temporary or permanent nerve injury, ischemia, fibrosis, infection, pain, discomfort, gas buildup resulting in temporary and transient crepitus or pain, bleeding, hematoma, seroma, subcutaneous induration, pigmentation changes, increased healing time, and/or unsatisfactory scarring. There may be additional risks associated with the use of other devices along with Renuvion/J-Plasma 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.