FDA Breakthrough Device Designations speed up the development and review of medical devices that can improve the lives of people with life-threatening or debilitating conditions.
Every year, approximately 1.6 million newborns will experience clinically significant apnea.
Prapela’s stimulation pad could become available sooner as a new treatment option for preterm newborns experiencing apnea.
BIDDEFORD, Maine, Jan. 5, 2023 /PRNewswire/ — Prapela, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to explore the use of its proprietary stimulation to treat apnea of prematurity (AOP), a cessation of breathing for 20 seconds or longer and a major morbidity of preterm infants. Breakthrough Device Designation accelerates the review of innovative medical devices that can improve the lives of people with life-threatening or irreversible debilitating conditions.
Prapela’s device is a mattress pad producing a unique vibration that boosts the brain’s control of breathing. Placed inside an incubator, radiant warmer, or hospital bassinet, preterm infants laying on Prapela’s pad experience a subarousal, stochastic stimulation that improves respiratory rhythm. While Prapela’s technology previously received Breakthrough Device Designation for improvement of breathing in newborns with prenatal opioid exposure, a study published in Pediatrics1 suggests Prapela’s stimulation could also help decrease apneic and oxygen desaturation events in preterm infants. Prapela is working with Tufts Medical Center and the University of Alabama at Birmingham to complete a large clinical trial to evaluate the device’s safety and effectiveness for AOP. A significant benefit of Prapela’s pad is that no wires or leads are connected to infants to deliver the stimulation. A simple on/off button activates the pad’s stimulation.