A Single-site Postmarket Retrospective Chart Review of Subdermal Coagulation Procedures with Renuvion®
Vaishali Doolabh, MD, FACS
The objective of this retrospective chart review was to collect safety and procedural information for patients who have previously undergone liposuction with which Renuvion was used as a tool for subdermal coagulation. All procedures occurred before August 2018. Thirty-two patients were identified (3 male and 29 female). The mean follow-up was 6 months (range, 3–8 months). None of the patients required a revision or secondary procedure suggesting 100% of patients had acceptable final outcomes.
APYX™ MEDICAL DISCLOSURES:
This literature was funded in whole by Apyx Medical: (1) the retrospective review study that is the subject of this article written by Vaishali Doolabh, MD, FACS was sponsored and funded by Apyx Medical and (2) Apyx Medical funded the publication of this article and edited to ensure, as much as possible consistency with cleared indications for use. The author is a paid consultant of Apyx Medical.
CLEARED INDICATIONS & MANUFACTURING DISCLOSURES
- The use of the terms “Skin tightening” and “body contouring” in relation to the use of the Renuvion/J‑Plasma® technology has not been approved or cleared by the FDA.
- 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 including skin tightening indication referenced in this article.
- Apyx Medical manufactures and owns the Renuvion/J-Plasma technology discussed in this article.
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/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.