Novel Device for Minimally Invasive Treatment of Pediatric Esophageal Atresia
Long-Gap Esophageal Atresia Device (LEAD) uses real time pressure measurements in a closed-loop feedback system to control a linear actuator that extends a wire and silicone nub. Pressure is automatically applied in cycles to the upper esophageal pouch by the nub to gently stretch the tissue.
Long-Gap Esophageal Atresia is a rare birth defect in which the esophagus is separated into an upper and lower pouch instead of being a continuous tube. Babies with this condition require immediate medical care, and upon reaching a threshold weight (roughly 2 months after birth), undergo the Foker procedure. This month-long process begins with an open surgery attaching tension sutures to the pouches. Periodically, doctors tug on the sutures, applying tension to the tissue and ultimately lengthening the pouches until the gap is closed enough for the ends to meet and be surgically attached. During those weeks, the babies are paralyzed to avoid suture tears and future complications. Even after completion, babies often go home with life-long complications due to tissue scarring and hindered neurodevelopment from anesthetics and lack of socialization. All together, the process takes approximately 120 days and costs families on average $576,000, largely due to the extended period of care in the Neonatal Intensive Care Unit (NICU). The problems with this barbaric procedure necessitate a solution that is minimally invasive, reduces recovery time, decreases associated risks, and lightens the financial burden families incur. Thus, Neoflex and Boston Scientific introduce LEAD–a noninvasive device that uses a linear actuator and closed-loop pressure feedback to apply automated, cyclical pressure to the upper pouch, gently stretching it toward the lower pouch. LEAD’s nature would allow babies to receive immediate, nonsurgical treatment with a quicker recovery time. Although the condition only affects about 250 babies per year in the U.S., the yearly market is about $144M and worthy of intervention. With LEAD, we expect a 65% reduction to this cost due to the removal of paralytics and a shorter NICU stay. Ultimately, this device would accomplish a combinatorial goal of lowering patient risk, decreasing recovery, and alleviating costs.