"Safety and Efficacy of Renuvion Helium Plasma to Improve the Appearance of Loose Skin in the Neck and Submental Region" Featured in Aesthetic Surgery Journal
Minimally invasive procedures that deliver thermal energy to subcutaneous tissue offer a solution when deciding between excisional and noninvasive options to address face and neck aging-related changes. A minimally invasive helium plasma device, Renuvion, was first utilized for subdermal tissue heating to reduce skin laxity under an FDA general clearance for cutting, coagulation, and ablation of soft tissue.
Objectives
The purpose of this study was to demonstrate the safety and effectiveness of the helium plasma device for improving the appearance of loose skin in the neck and submental region.
Methods
Patients undergoing the procedure with the helium plasma device in the neck and submentum were studied. They were seen for 6 months following the procedure. The primary effectiveness endpoint for improvement in lax skin in the treatment area was determined by 2 of 3 blinded photographic reviewers. The primary safety endpoint was the level of pain after treatment.
Results
The primary effectiveness endpoint was met; 82.5% demonstrated improvement at Day 180. The primary safety endpoint was met; 96.9% of patients experienced no pain to moderate pain to Day 7. There were no serious adverse events reported related to the study device or procedure.
Conclusions
The data demonstrate benefit to patients by improvement of the appearance of lax skin in the neck and submental region. Outcomes resulted in US Food and Drug Administration 510(k) clearance in July 2022, expanding indications for the device to include subcutaneous dermatological and aesthetic procedures to improve the appearance of loose skin in the neck and submental region.
Recent News in Clinical Publications
- "An Intelligent Diagnostic Model for Melasma Based on Deep Learning and Multimode Image Input" Featured in Dermatology and Therapy
- "Investigation of the Precision of the VISIA® Complexion Analysis Camera System in the Assessment of Skin Surface Features" Featured in GMS Interdisciplinary Plastic and Reconstructive Surgery DGPW
- "Measurement of the Effects of the IMAGE MD® Skin Care Regimen on Skin Surface Features Via Modern Imaging Technology with the VISIA® Complexion Analysis Camera System" Featured in GMS Interdisciplinary Plastic and Reconstructive Surgery DGPW
- "Safe and Effective Lip Enhancement with VYC-15L in Chinese Adults" Featured in Clinical, Cosmetic and Investigational Dermatology
Most Recent News
- "An Intelligent Diagnostic Model for Melasma Based on Deep Learning and Multimode Image Input" Featured in Dermatology and Therapy
- "Investigation of the Precision of the VISIA® Complexion Analysis Camera System in the Assessment of Skin Surface Features" Featured in GMS Interdisciplinary Plastic and Reconstructive Surgery DGPW
- "Measurement of the Effects of the IMAGE MD® Skin Care Regimen on Skin Surface Features Via Modern Imaging Technology with the VISIA® Complexion Analysis Camera System" Featured in GMS Interdisciplinary Plastic and Reconstructive Surgery DGPW
- "Safe and Effective Lip Enhancement with VYC-15L in Chinese Adults" Featured in Clinical, Cosmetic and Investigational Dermatology