TECHNICAL DATA SUMMARY
- Viscosity Control: Optimized for controlled extrusion through 25G–27G long-reach laryngeal needles, suitable for both in-office and OR settings [5].
- Radiopacity: High-density CaHA particles ensure the implant is clearly visible on CT and radiographic imaging for post-procedural verification [6].
- Tissue Stability: Synthetic CaHA is identical to the mineral constituent of bone, ensuring zero risk of allergic reaction and high resistance to resorption [7].
CLINICAL INDICATIONS
- Unilateral Vocal Fold Paralysis/Paresis: Augments the displaced fold to allow for midline contact, restoring voice clarity and maximum phonation time (MPT) [5].
- Vocal Fold Atrophy (Presbylarynx): Restores bulk to aged or thinning vocal folds to reduce vocal effort and breathiness.
- Glottal Gaps: Addresses insufficiency resulting from trauma, surgery, or systemic disease.
THE ADVASAF ADVANTAGE FOR ENTS
- American Precision: Designed and manufactured in the USA under rigorous ISO 13485 quality controls.
- Predictable Medialization: Minimal resorption of the gel carrier ensures that the initial surgical correction remains stable long-term [7].
- Partner Support: Advasaf offers white-label opportunities for specialized medical distributors looking to enter the ENT market.
TECHNICAL SOURCES & REFERENCES
- UC Davis Center for Voice (2023). Clinical Standards for Vocal Fold Augmentation.
- Severn Healthcare / Renu Voice IFU. Radiopacity and CT Imaging of CaHA Implants.
- Laryngoscope (127:1125-1130). Long-term Durability of CaHA in Laryngeal Procedures.