'We have to be careful'

Friday, July 31, 2009

POWAY, Calif.--ResMed received FDA approval about five years ago to market its Kidsta mask to pediatric patients ages 7 and up. But even Don Darkin, senior vice president of global interface, acknowledges that the “clunky” Kidsta is far from an ideal solution.

Look for a significant improvement this fall when the company releases a second mask for the 7-plus age group. If all goes according to plan, ResMed should have a mask out in about 18 months for kids age 2 and up. You can’t rush these things, Darkin said.

“We’ve got to get some substantive data that will give us the confidence that it will be a benefit and not a problem,” he said. “We have to be very careful when working with kiddies.”

Philips Respironics’ Profile Lite Nasal Mask also has FDA approval for kids age 7 and older. Like ResMed, Respironics has other pediatric products in the pipelilne, said Jason Traynor, global product manager for sleep therapy.

“We recognize it as a need,” Traynor said. “When you talk to  thought leaders in this area, there is a consistent message that they need to treat this group.”