FDA clears ResMed's pediatric nasal mask

Wednesday, May 31, 2006

SAN DIEGO - ResMed announced last month plans to launch the Mirage Kidsta nasal mask and the VPAP III ST-A--the first-ever pediatric system cleared by the FDA for treatment of obstructive sleep apnea and respiratory insufficiency in the hospital and home. The FDA cleared the use for children 7 years and older, or weighing more than 40 pounds. The VPAP III ST-A is currently available and the Mirage Kidsta is expected to ship in late summer. The prevalence and seriousness of sleep apnea among children has gained recognition in recent years. A 2003 study in the journal Pediatrics found that children whose parents reported frequent or loud snoring or other sleep-disordered breathing (SDB) were more likely to be sleepy during the day or have problem behaviors like hyperactivity.