Prapela Stimulation Mattress Pad Gets Second Breakthrough Device Nod

The FDA has granted a second Breakthrough Device designation to Prapela’s stimulation device, this time to treat preterm infants with apnea of prematurity, which causes breathing to stop for 20 seconds or longer and can lead to death.

The device is a mattress pad that vibrates, sending signals to the brain to improve respiratory rhythm. The pad can be placed inside an incubator, radiant warmer or hospital bassinet.

The stimulation pad is being evaluated in a clinical trial in partnership with Tufts Medical Center and the University of Alabama at Birmingham.

The device previously received Breakthrough Device status for improved breathing in newborns with prenatal opioid exposure.