Skip to content

Injectable implants for Vocal Fold Insufficiency

Order now

FOR LARYNGOLOGY BY LARYNGOLOGY®

Welcome at AmplioVox

It’s our mission to deliver vocal fold augmentation materials to providers around the world. Our product portfolio consists:  RENÚ® Gel, RENÚ® Voice and Transoral Neo Needle. Rooted in our deep expertise and collaboration, we aim to be the trusted partner in delivering exceptional products and fostering the development of cutting-edge technologies—from laryngology, for laryngology.®

Products

Renu Gel - AmplioVox

Renu Gel

  • 1.5cc pre filled syringe
  • Short acting product
  • 100% biodegradable
  • Ergonomically shaped finger grips syringe
  • Controlled viscosity, consistently
  • Easy to inject
  • 2-year shelf life

Renú Gel is an injectable vocal fold implant intended for short-term augmentation. Renú Gel is a buffered hydrogel and it is the carrier gel used in Renú Voice. The implant can be injected percutaneously or with the Transoral Neo Needle supplied separately.

Renú Gel is indicated for short term vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent. Renú Gel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing vocal fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulty may be an urgent indication.

Click here for IFU
Renu Voice - AmplioVox

Renu Voice

  • 1.5cc pre filled syringe
  • Longevity 12 – 18 months
  • 100% biodegradable
  • Ergonomically shaped finger grips syringe
  • Controlled viscosity, consistently
  • Easy to inject
  • 2-year shelf life

Renú Voice is an injectable vocal fold implant intended for long-term augmentation. Renú Voice is a buffered hydrogel containing synthetic Calcium Hydroxylapatite (CaHA) particles 25 to 45 microns in size. The implant can be injected percutaneously or with the Transoral Neo Needle supplied separately.

Renú Voice is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent. Renú Voice injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing vocal fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulty may be an urgent indication.

Click here for IFU
Transoral Neo Needle - AmplioVox

Transoral Neo Needle

  • 24 gauge needle tip with 1 depth markings
  • The malleable shaft is 16 gauge
  • The overall length of 9.84 inches (25 cm)
  • Now Available

The Transoral Neo Needle is intended to be used for the transoral injection of Renú Voice and Renú Gel. The main shaft is sufficient in stiffness to allow for tissue movement and reduce needle tip vibration. The shaft can be bend to individual needs of the surgeon and the anatomy of the patient.

Injection Techniques

RENÚ® Percutaneous procedure

Renú can be injected via three percutaneous approaches.

  • Thyroid Cartilage Approach
  • Cricothyroid Cartilage Approach
  • Thyrohyoid Approach
RENÚ® Percutaneous procedure

Thyroid Cartilage Approach

RENÚ® Percutaneous procedure
Cricothyroid Cartilage Approach
RENÚ® Percutaneous procedure
Thyrohyoid Approach

RENÚ® Trans-Oral Office Based Procedure

Renú can be injected via the trans-oral office based approach. The Trans-Oral Neo Needle can be bend to the surgeons individual need.

  • Topical anesthesia (dripped on larynx)
  • Attach appropriate needle to RENÚ® syringe
  • Prime needle with RENÚ®
  • Special Note – record syringe starting and ending volume for exact volume delivered to patient.
RENÚ® Trans-Oral Office Based Procedure

Trans Oral Renú injection

RENÚ® Trans-Oral Office Based Procedure

Trans Oral Renú injection

RENÚ® Trans-Oral Operating Room-OR Procedure

Renú can be injected via the OR trans-oral approach. The Trans-Oral Neo Needle can be bend to optimize microscope visualization.

  • Visualization via direct laryngoscopy or micro-laryngoscopy
  • Inject with approximately 10 – 15% over correction
RENÚ® Trans-Oral Operating Room-OR Procedure
Operating Room Trans Oral Injection
Brochure
Get in touch

Important Safety Information

RENÚ® Voice is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent. RENÚ® Voice injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing vocal fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulty may be an urgent indication.

RENÚ® Gel is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent. RENÚ® Gel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing vocal fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulty may be an urgent indication.

After injection of RENÚ® Voice or RENÚ® Gel, patients may experience transient throat soreness, bruising, swelling, or other local side effects. More rare side effects may include over-injection or under-injection that may require repeated intervention. As with any injection, there may be a risk of infection.

References:

  • Data on file, AmplioVox.
  • Mallur PS, et al. Safety and efficacy of carboxymethylcellulose in the treatment of glottic insufficiency. The Laryngoscope. 2012;122:322–326. https://doi.org/10.1002/lary.21930.
  • Hughes RGM, Morrison M. Vocal cord medialization by transcutaneous injection of calcium hydroxylapatite. Journal of Voice. 2005;19(4):674-678.
  • Carroll TL, Rosen CA. Long-term results of calcium hydroxylapatite for vocal fold augmentation. The Laryngoscope. 2011;121:313–319.
  • RENÚ® is a Registered trademark of Cytophil, Inc.