What Are Renú® Voice And Renú® Gel?
Renú® Voice and Renú® Gel are both injectable implants. Renú® Voice contains microspheres of calcium hydroxylapatite (CaHA), a biocompatible material that is suspended in a hydrogel carrier. Renú® Voice and Renú® Gel are both designed to replace volume lost in the tissue of your vocal folds. These injections assist in bringing the folds closer together to aid in the restoration of your voice for long-term improvement.
What Will I Experience During And After My Renú® Voice And/Or Renú® Gel Procedure?
In most cases, the Renú® Voice and/or Renú® Gel procedure will be performed in your physician’s office or treatment clinic. You will be made comfortable with the use of either a topical or local anesthetic for your treatment. This process takes about 15 – 20 minutes. During which time you may be asked by your doctor to make sounds to assess the improvement of your vocal quality.
Is Surgery A Better Option?
Only your physician should make the evaluation and recommendation for surgery. If surgery is required, it does demand that you go to an operating room and receive general anesthesia with a recovery period. Renú® Voice and Renú® Gel injections are a non-surgical option provided in your physician’s office.
What Are My Next Steps?
Schedule a time to talk to your physician about Renú® Voice and/or Renú® Gel to see if vocal fold injections are the right option for you.
Where Can I Purchase Renú® Voice and Renú® Gel?
Please contact Cytophil, Inc. by calling toll free at +1 855-433-2765
Does Renú® Voice and Renú® Gel Harden After Injection?
The short answer is no. Since osteoblasts and osteoclasts do not exist above the periosteum, there are no catalytic cells to stimulate hardness.
Should I Expect Any Patient Side Effects?
Few side effects have been reported and those that are tend to center on those associated with injected implants. Tenderness and mild swelling at the injection site are commonly reported.
How Long Will Renú® Voice And Renú® Gel Last In My Patients?
Renú® Voice and Renú® Gel is comprised of two components each dissipating over different periods of time. The quickest to be absorbed is the carrier gel which takes a few months. Next the CaHA particles are broken down gradually into calcium and phosphate ions metabolized by the body’s natural process over a couple of years. Thus, Renú® Voice and Renú® Gel should provide your patients long-lasting results of one to two years.
Does Renú® Voice And Renú® Gel Require Special Storage?
No. Renú® Voice and Renú® Gel may be stored at ambient room temperature between 59°F and 90°F (15°C and 32°C). Renú® Voice and Renú® Gel may be stored if packaging is intact and undamaged for up to two years. REMINDER: Renú® Voice and Renú® Gel are manufactured as a single-use product and once opened, should not be stored or re-used.
How Is Renú® Voice And Renú® Gel Packaged?
Renú® Voice and Renú® Gel comes in a sterile foil pouch containing a single-use, pre-filled syringe inside a protective outer box. Renú® Voice or Renú® Gel syringe has a packaged volume of 1.5cc. Upon opening the foil pouch it is common to find water droplets that are consistent with the normal sterilization process. Renú® Voice and Renú® Voice are manufactured as a single-use product and any post-procedure product remaining in the syringe should not be stored or re-sterilized for future use.
How Do I Know If Need To Consider Treatment For My Voice?
Voice issues sometimes occur but if you are experiencing symptoms that persist or even seem to be getting worse, treatment may be required.
- A weak or airy quality to your voice
- Difficulty or inability to increase your voice volume
- Difficulties in breathing and/or swallowing
- Difficulties in swallowing resulting in choking
- Persistent feeling of something in your throat
Symptoms like the ones described above could be an indication of other health concerns including the possibility of throat cancer. Because these issues may have serious health implications, you should see your physician for evaluation.
Whom Do I See For Persistent Issues With My Voice?
An Ear, Nose and Throat (ENT) physician, also know as otolaryngologist, will conduct an exam to evaluate whether your voice issues are of a serious nature and need medical treatment. This process will include exploring your medical history and performing a physical exam of your vocal folds. Vocal fold examination can be as simple as looking into your throat with a small mirror and may also include looking closer with a camera tube that is passed through the nose known as an endoscope. If an endoscope is used, your throat is numbed to provide you comfort during the vocal exercises so your physician can see your vocal folds in motion.
If Treatment Is Needed What Choices Do I Have?
If your medical exam resulted in insufficient vocal fold performance, than your physician may consider one or more treatment choices.
- Seeing a speech-language pathologist to assist in better voice control
- Surgery may be indicated to move the vocal folds closer together
- Injection Therapy using Renú® Voice and/or Renú® Gel is a non-surgical option to bring the vocal folds closer together for long-term improvement
Vocal Fold Inspiration
Vocal Fold Phonation
Vocal Fold Issue at Attempted Phonation
Rosen, C.A., J. Gartner- Schmidt,(et al.), “Vocal fold augmentation with calcium hydroxylapatite (CaHA). Otolaryngology Head and Neck Surgery (2007) 136, 198-204
Rosen, C.A., J. Gartner- Schmidt,(et al.), “Vocal fold augmentation with calcium hydroxylapatite (CaHA): Twelve month report. Presented on May 19, 2006 at the Annual Meeting of the American Bronco-Esophageal Association, Chicago, IL.
Rosen, Clark A. (et al.), “Vocal Fold Augmentation with Injectable Calcium Hydroxylapatite: Short-Term Results.” Journal of Voice, September 2004, Vol. 18, No. 3. p. 387-391.
Belafsky, Peter C. (et al.), “Vocal Fold Augmentation with Calcium Hydroxyapatite.” Otolaryngology – Head and Neck Surgery, October 2004, Vol. 131, No. 3, p. 351-354.
Chhetri, Dinesh K. (et al.), “Injection Laryngoplasty with Calcium Hydroxylapatite Gel Implant in an In-Vivo Canine Model.” Annals of Otology, Rhinology & Laryngology, April 2004, Vol. 113, No. 4, p. 259-264.
Hughes, Richard G. M., “Vocal Cord Medialization by Transcutaneous Injection of Calcium Hydroxylapatite.” Journal of Voice, December 2005, Vol. 19, No. 4, p. 674-678.
Kwon, T. K. (et al.), “Preliminary Results of a New Temporary Vocal Fold Injection Material.” Journal of Voice, December 2005, Vol. 19, No. 4, p. 668-673.
Note: These studies were done with Prolaryn™ Plus or Prolaryn Gel (Formerly Radiesse® Voice or Radiesse gel, Merz) but are relevant since Renu® voice and Renu® gel are substantially equivalent products and contain the same components in the equivalent formulations. Radiesse® and Prolaryn™ are registered trademarks or trademarks of Merz North America.
