A Post-Market Evaluation of Procedures in which Renuvion® was used as a Tool for Subdermal Coagulation

ITEM TYPE:

Abstract

AUTHORS:

Vaishali B. Doolabh, MD; Paul G. Ruff, IV, MD; and Edward M. Zimmerman, MD

SUMMARY:

A retrospective, IRB approved, chart review of 37 patients at three clinical sites was conducted on patients who have previously undergone a procedure where a helium driven plasma radiofrequency device was used for subdermal coagulation. The primary purpose of this study was to collect safety data. The secondary purpose was to determine the effect of tissue coagulation through analysis of retrospective before and after images. Subject Satisfaction data and related procedural information was also collected.

APYX® MEDICAL DISCLOSURES:

FINANCIAL DISCLOSURES
This literature was funded in whole by Apyx Medical: (1) the retrospective review study that is the subject of this abstract authored by Vaishali Doolabh, MD, Paul G. Ruff, IV, MD, and Edward M. Zimmerman, MD was sponsored and funded by Apyx Medical and (2) Apyx Medical edited to ensure, as much as possible consistency with cleared indications for use. Dr. Doolabh is a paid consultant and clinical investigator for Apyx Medical. Dr.’s Ruff and Zimmerman are paid consultants, members of the Medical Advisory Board, and clinical investigators for Apyx Medical.

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
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 all energy devices there are inherent risks associated with its use, refer to the IFU for further information.

INTENDED USE DISCLOSURE
The Renuvion system (Precise, Precise Open® & APR Handpieces with compatible electrosurgical generators) are intended to be used for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Refer to the Instructions for Use for the currently approved or cleared indications.

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