ITEM TYPE:

Journal Article

AUTHORS:

Paul G. Ruff IV, MD, FACS

ABSTRACT:

Purpose: To demonstrate the safety and effectiveness of the Renuvion APR Device as a percutaneous, minimally invasive aesthetic treatment to improve the appearance of lax tissue in the neck and submental region.

Design: A prospective, pivotal phase, evaluator-blinded study of 65 subjects at 6 US sites who received a single Renuvion treatment.

The bilateral treatment area included the tissue of the neck (to the posterior border of the sternocleidomastoid muscle) and submental area. Treatment was performed through three (3) incisions (2 periauricular and 1 submental) with each incision large enough to allow for gas egress. Treatment was 4-6 treatment passes at 70% power and 1.5 LPM of helium flow with an activation speed of approximately 1-3 cm/s.

Follow-up visits at D1, D7, D14, D30, D90, and D180.

Primary Effectiveness Endpoint was improvement in the appearance of lax tissue in the neck and submental region at D180 determined by 2 of 3 blinded Independent Photographic Reviewers (IPR). Primary Safety Endpoint was the level of pain and discomfort after treatment as reported by the subject on an 11-point Numeric Rating Scale (NRS) through D7.

Findings: Primary effectiveness endpoint met; 82.5% demonstrated improvement at D180 by IPR. Primary safety endpoint met; 96.9% of subjects experienced no pain to moderate pain to D7. Mean NRS scores were 0.9, 2.3, and 0.6 at immediately post-procedure, D1, and D7.

Additional Endpoints: (1) 76.2% demonstrated improvement at D90 by IPR. (2) 92.1% and 85.5% rated improvement (Improved, Much Improved, or Very Much Improved) by Subject GAIS at D90 and D180. (3) 95.2% and 87.1% rated improvement by Investigator GAIS at D90 and D180. (4) At D180, 72.6% of subjects reported being happy with the results of the procedure. 74.2% would recommend the procedure to a friend. 75.8% would consider having the same type of procedure performed on another part of their body. (5) 62.3% demonstrated quantitative improvement of at least 20mm2 of lift in the neck and submental region at D180. (6) 68.3% demonstrated quantitative improvement in submental volume at D180. (7) Most common events reported: 92.3% edema/swelling, 86.2% temporary sensory nerve changes, 55.4% ecchymosis/bruising, 46.2% erythema, 40.0% crepitus, 24.6% pain/tenderness. (8) Mean NRS scores were 0.3 and 0.2 at D14 and D30.

Summary: The totality of the data demonstrates benefit to subjects in the improvement of the appearance of lax tissue in the neck and submental region. The primary effectiveness endpoint for this study was achieved at 82.5%. The primary safety endpoint was achieved at 96.9%. There were no serious adverse events reported as related to the study device or the study procedure. Further, the adverse events were within the range expected for subdermal treatments in the neck and submental area.

APYX® MEDICAL DISCLOSURES:

FINANCIAL & CONTENT DISCLOSURE
The authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article. No funding was received for this article. Drs DiBernardo, Bharti, and Kortesis are paid consultants for Apyx Medical, and Dr Duncan is a member of Apyx Medical’s Medical Advisory Board. The opinions contained herein are those of the authors and do not necessarily represent the official position or policies of Apyx Medical, Inc.

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

INDICATIONS FOR USE & INTENDED USE DISCLOSURES

• • The Renuvion APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation, and ablation of soft tissue during open surgical procedures.
  • The Renuvion APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.
  • The Renuvion APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical (specifically BVX-200H, BVX-200P, APYX-200H, APYX-200P, APYX-RS3, and APYX-JS3).
  • Apyx Medical wants to present you with current scientific discourse. Specific usage outside of the cleared indications may not be safe or effective.
  • The use of Renuvion with liposuction has not been approved or cleared by the FDA.

RISKS

• • As with all energy devices there are inherent risks associated with its use. Risk associated with the use of the Renuvion APR 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, scarring, asymmetry and/or unacceptable cosmetic result.

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.