Tissue-repair material · intravaginal type
- Main material
- Cross-linked Dextran
- License
- No. 13-1648
- Format
- 1.1mL prefilled syringe
Intended use in Korea
Temporary improvement of vaginal laxity symptoms in adult women
WINKFEEL · Product information
WINKFEEL Hera
A cross-linked dextran tissue-repair medical device for temporary improvement of vaginal laxity symptoms in adult women.
Product information
Licence and intended use
Before use
Not for postmenopausal or pregnant women, among other contraindications. Risks include pain, infection, nodules and vascular occlusion. A clinician must assess suitability.
A partial summary of the Korean instructions for use. Ask a clinician about the complete contraindications and precautions.
Request study information ↗02 / MATERIAL & RESPONSE
Understanding dextran in Hera
Hera supplements volume beneath the vaginal mucosa and induces collagen formation around dextran particles.
01
Volume supplementation
The injected material occupies space beneath the vaginal mucosa, supplementing tissue volume.
02
Collagen formation
Collagen forms around the dextran particles, creating surrounding tissue.
03
Tissue support
The collagen tissue surrounding the particles may help support vaginal tissue and its elasticity.
Dextran particlesSurrounding collagenSurrounding tissue
Conceptual diagram only; it does not show actual tissue changes or treatment outcomes. Individual responses and outcomes may vary.
03 / CLINICAL EVALUATION
Clinical evaluation in the Hera instructions
Vaginal laxity questionnaire responses at 24 weeks.
Participants reporting VLQ ≥5
Primary efficacy ITT analysis: 122 participants · 81 test / 41 control
24 weeksAssessment time
122Primary analysis
Randomised, single-blind, multicentre study. 126 enrolled; 122 in the primary efficacy analysis. Investigational device: LiCOL GOLD.
Request study information ↗69.1% is a questionnaire response rate at 24 weeks, not an overall treatment success rate. It does not describe Diamond or establish long-term duration. Transient pain, itching and urticaria were also reported.
Source: WINKFEEL Hera Korean instructions (2023.02), clinical trial summary. Study period: 2019.06–2020.06.