Evaluation of Bowel Injury in a Porcine Model Following Ablation with J‑Plasma® Helium-Based Plasma Technology
Alexander B. Olawaiye
Objective: The purpose of this study was to evaluate the effect of J-Plasma and the argon beam coagulator (ABC) on porcine bowel.
Methods: J-Plasma (test) and the Argon Beam Coagulator (control) were used to treat the jejunum, ileum, and large intestine of seven (7) female Yorkshire cross pigs (J-Plasma: acute, n=1 and chronic n=3; ABC: acute n=1 and chronic n=2). The acute animals were euthanized 4 hours following treatment and the chronic animals were survived to 14 days then euthanized. Following euthanasia, all treated sites were evaluated grossly for evidence of perforation.
Results: Perforations were observed in all treatment sites of all control animals, acute and chronic, with all chronic control animals requiring early termination or resulting in an early death. There were no perforations observed in any test animals that survived to scheduled sacrifice; one test animal expired early due to non-device related complications.
Conclusions: This study demonstrates that J-Plasma can be safely utilized to treat small and large porcine intestine with no perforations observed. This device is an alternative tool in the surgical treatment of intra-abdominal cancer when removing cancer from peritoneal and bowel surfaces.
APYX® MEDICAL DISCLOSURES:
FINANCIAL & CONTENT DISCLOSURE
This literature was funded 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.
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.
- 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.