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ResMed to Launch the First Pediatric System to Gain US FDA Clearance

San Diego, CA - May 3, 2006

The Mirage Kidsta™
The Mirage Kidsta™
VPAP® III ST-A
VPAP® III ST- A
ResMed Corp. today announced an important milestone in helping patients with the upcoming launch of the first positive airway pressure (PAP) system cleared by FDA for pediatric use (7 years and older, or weighing more than 40 lbs) in the hospital and home. The Mirage Kidsta(tm) nasal mask and the VPAP® III ST-A is the first pediatric system cleared by FDA for treatment of obstructive sleep apnea and respiratory insufficiency in the hospital and home.

The Mirage Kidsta is based on ResMed's high-quality Mirage(tm) platform, combining dual-wall cushion technology and user-friendly design for a comfortable mask that is easy to use, effective and unobtrusive. Combined with the VPAP III ST-A, the only bilevel ventilator system FDA cleared for pediatric use in the hospital and home, ResMed's complete therapy solution is safe and effective, so parents can rest assured their children are receiving maximum health benefits from PAP therapy. The VPAP III ST-A is available currently 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 such as hyperactivity, inattentiveness or aggressiveness.

"Pediatric specialists are increasingly aware of the prevalence and symptoms of sleep apnea and they recognize the need for suitable therapy options for their pediatric patients," stated Dr. Rochelle Turetsky, M.D., Gaylord Hospital. "As a result, pediatricians have seen an increasing and unmet need for an approved pediatric device. ResMed's recent FDA clearance of a full therapy system for pediatric use in the hospital and home is excellent news for patients and physicians and will meet a growing need in pediatric practices."

"The Mirage Kidsta and VPAP III ST-A system answer the long-standing market demand for a safe and effective therapy option for children with sleep apnea and respiratory insufficiency," stated Michael Farrell, VP of Marketing. "We have already been supporting pediatric patients with the Mirage Kidsta in Canada and Latin America; now, we have the only bilevel system FDA cleared for pediatric use in the hospital and home. We have an extraordinary opportunity to provide a complete treatment system to a previously under-supported patient group in the United States. Gaining FDA clearance for the VPAP III ST-A and the Mirage Kidsta is a huge step forward for children, their parents and healthcare providers."

The Mirage Kidsta has been commercially available in Europe since 2004. It has been used to treat patients in Germany, France, the UK and other countries. The VPAP III ST-A has been available to treat adult patients in the US since 2004. For more information about ResMed's pediatric system, visit the company's multilingual website at www.resmed.com or contact Customer Service toll-free at (800) 424-0737.

About ResMed

ResMed is a global leader in medical equipment for the screening, treatment and management of SDB and other respiratory disorders. We provide a comprehensive range of products through direct offices in the United States and more than 65 other countries. ResMed provides reliable products, quality systems and complete solutions for its customers and their patients.

 

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