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Frequently asked questions about PROLARYN GEL and PROLARYN PLUS

PROLARYN GEL is an injectable aqueous/glycerin/carboxymethylcellulose gel implant. PROLARYN GEL injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold in the midline for improved phonation. PROLARYN GEL is suitable for vocal fold augmentation in patients for whom only short-term augmentation may be required, or in patients wishing to evaluate augmentation before making a decision to undergo long-term augmentation with PROLARYN PLUS.
PROLARYN PLUS is an injectable implant containing the same aqueous/glycerin/carboxymethylcellulose gel found in PROLARYN GEL. Suspended in the gel are consistently shaped and sized synthetic calcium hydroxylapatite (CaHA) microspheres (diameter range of 25 to 45 μm). Over time the gel is dissipated in vivo and replaced with soft tissue growth, while the CaHA remains longer at the site of injection. The result is long-term restoration and augmentation of the vocal folds.
PROLARYN GEL and PROLARYN PLUS are supplied sterile in a prefilled single-use syringe, individually packaged in a foil pouch with 2 types of injection needles and boxed for convenient storage. Each prefilled syringe contains 1.0 cc of PROLARYN GEL or PROLARYN PLUS. When opening the foil pouch, the presence of several drops of water or moisture is normal and should be expected. The contents of the syringe are intended for single use only and cannot be resterilized or stored for future use once the pouch is opened.
PROLARYN GEL and PROLARYN PLUS can be stored at room temperature between 15° C and 32° C (59° F and 90° F) for up to 2 years in their original sealed packaging. Once removed from the original packaging, PROLARYN GEL and PROLARYN PLUS should be used immediately. Open products should not be re-stored or reused.
PROLARYN GEL and PROLARYN PLUS may be injected via 2 procedure options.
Transoral
Percutaneous
PROLARYN GEL is a temporary implant and resorbs within a period of 3-6 months.
PROLARYN PLUS has been shown to last up to 1 year.
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