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PROLARYN PLUS clinical study results

PROLARYN PLUS was evaluated in a multicenter, open-label, prospective clinical study.1

STUDY DESIGN: Each patient served as his/her own control. A 5-point rating scale of vocal effort was used: greatly improved, significantly improved, somewhat better, no change, worse. Patients also rated the amount of effort they felt was required for phonation using a 100-point visual analog scale (the higher number, the more effort upon phonation).1

At 12 months, both patients and physicians reported:

Nearly 70% of patients (n=63) had "greatly improved" or "significantly improved" voice.1

Patient- and physician-observed improvement was confirmed by stroboscopic documentation of vocal fold augmentation and glottal closure.1

STROBOSCOPY: INDICATION OF IMPROVED GLOTTAL CLOSURE (N=59)1

Stroboscopy was used to evaluate vocal fold vibratory and closure features at each patient visit. At baseline the duration of closure in 85% of patients was classified as always open or predominantly open. In contrast, the 12-month evaluation found that only 20% of treated patients had always open or predominantly open durations of closure.

Which patients are candidates for PROLARYN PLUS?

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Reference
  1. Rosen CA, Gartner-Schmidt J, Casiano R, et al. Vocal fold augmentation with calcium hydroxylapatite: twelve-month report. Laryngoscope. 2009;119:1033-1041.
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