CARPINTERIA, Calif.--(BUSINESS WIRE)--InHealth Technologies has announced that it is now the exclusive distributor of RENÚ Voice and RENÚ Gel in the United States.
RENÚ Voice and RENÚ Gel offer cost-effective short- or long-term treatment options for vocal fold insufficiency (VFI).1
RENÚ Voice and RENÚ Gel have been proven substantially equivalent to other available injectable options. Both products are FDA-cleared for injectable vocal fold augmentation applications.
Both RENÚ Voice and RENÚ Gel provide a greater volume of material than competitive products: 1.5 cc vs. 1.0 cc.1 The greater volume ensures enough material in a single syringe to meet patient-specific treatment requirements. This also helps eliminate the waste, inconvenience, and added cost of opening additional sterile, preloaded syringes.
RENÚ Voice is for long-term augmentation. It is a buffered hydrogel of synthetic, proven-biocompatible calcium hydroxylapatite (CaHA) particles 25 to 45 microns in size for consistent and easy injection.1
RENÚ Gel is for short-term augmentation. It is a buffered hydrogel of sodium carboxymethylcellulose2 and glycerin. It resorbs slowly in vivo, providing a scaffold for local tissue infiltration.3
RENÚ Voice and RENÚ Gel are provided in sterile, ready-to-use 1.5 cc syringes with ergonomic finger grips and a two-year shelf life. Physicians can inject the products percutaneously with a needle of their choice or with the RENÚ Double-Bevel, Transoral Needle, supplied separately.3,4
RENÚ Voice and RENÚ Gel are backed with comprehensive support from InHealth Technologies, a global leader that “speaks ENT.”
Constantine Davlantes, Vice President and General Manager of InHealth Technologies, says, “We are very proud to be distributing RENÚ Voice and RENÚ Gel. Now, healthcare professionals and patients have a value-driven option to effectively and cost-effectively treat VFI from a partner dedicated to the ENT community.”
RENÚ Voice and RENÚ Gel are manufactured by Cytophil, Inc.
For more information or to order RENÚ Voice and RENÚ Gel, call InHealth Technologies at 800-477-5969, +1-805-684-9337, or visit www.inhealth.com/renu.
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.
About InHealth Technologies
InHealth Technologies, part of Freudenberg Medical LLC, is a world leader in the field of tracheoesophageal voice restoration after total laryngectomy, with such well-known brands as Blom-Singer® Voice Restoration Systems. In addition, InHealth is committed to the ENT community with products such as RENÚ Voice and RENÚ Gel for the treatment of vocal fold insufficiency, Katz Extractor® Oto-Rhino Foreign Body Removers, and the Blom-Singer® Nasal Septal Perforation Prosthesis.
References
- Data on file, InHealth Technologies.
- 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.
