PROLARYN PLUS helps
you close the gap1

How PROLARYN PLUS works

PROLARYN PLUS is an injectable implant containing the same aqueous/​glycerin/​carboxymethylcellulose gel found in PROLARYN GEL.1 Suspended in the gel are consistently shaped and sized synthetic calcium hydroxylapatite (CaHA) microspheres (diameter range of 25 to 45 μm).1

PROLARYN® PLUS packaging.

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.1

PROLARYN PLUS
initially performs as a bulking agent.

Macrophages start to degrade gel carrier (2–3 months).

New collagen forms. Collagen growth aids in long-term augmentation that may last for a year in many patients. Ultimately, CaHA particles start to degrade and are metabolized by macrophages.

PROLARYN® PLUS packaging.
Long-term restoration and augmentation

Improve glottal function with PROLARYN PLUS injectable implant in patients with vocal fold insufficiency.1

Over 15 years
of treatment2

Observed improvement in voice for up to 12 months3

Contains synthetic version of calcium hydroxylapatite (CaHA), a primary mineral constituent of bone and teeth1

PROLARYN PLUS is a CaHA implant that has been studied in a multicenter, prospective trial

Can be injected in‑office or in the operating room

PROLARYN PLUS clinical study results

PROLARYN PLUS was evaluated in a multicenter, open-label, prospective clinical study.3

STUDY DESIGN: Each patient served as his or her own control. A 5-point rating scale of vocal effort was used: greatly improved, significantly improved, somewhat better, no change, or 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).3

At 12 months, both patients and physicians reported:

Nearly 70% of patients (n=63) had “greatly improved” or ”significantly improved” voice.3

Patient- and physician-observed improvement was confirmed by stroboscopic documentation of vocal fold augmentation and glottal closure.3

STROBOSCOPY: INDICATION OF
IMPROVED GLOTTAL CLOSURE (N=59)3

Graph showing the duration of glottal closure in patients after 12 months.

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?

Download PROLARYN PLUS
Instructions for Use

References

  1. PROLARYN PLUS [Instructions for Use]. Raleigh, NC: Merz North America, Inc.; 2016.
  2. Data on file. Raleigh, NC: Merz Pharmaceuticals, LLC; 2022.
  3. Rosen CA, Simpson CB. Glottic insufficiency: Vocal fold paralysis, paresis, and atrophy. In: Operative Techniques in Laryngology. Heidelberg, Germany: Springer-Verlag; 2008.