Project Description: 

Esophageal strictures are hourglass-like narrowings in the throat that make it difficult to swallow, leading to long-term effects on a child’s development due to malnutrition. Standard treatments involve relieving the stricture using a balloon dilator, a $100 million market annually in the U.S. However, each procedure requires full general anesthesia. Studies have shown that frequent anesthesia exposure can have negative effects on the neurological development of infants. To address this, our team developed a new device to more effectively treat esophageal strictures by limiting the required number of doses of anesthesia. This design implements a multi-use esophageal balloon dilator with a nasogastric feeding tube and is designed for small children with recurrent strictures. The device is indwelling and can safely remain within the infant for up to 30 days, allowing for multiple dilations without additional anesthesia. While in place, the feeding tube allows parents and medical professionals to ensure that these children receive proper nutrition while the stricture is treated. In addition, doctors can stretch the esophagus more gently and more often, lowering the risk of rupturing the esophagus. The device conforms as closely as possible to existing esophageal dilator and feeding tube standards to maintain safety and integrate advantages from these existing devices. Our testing concluded that this design applies an equivalent force on esophageal tissue as the current market standard balloon dilator when inflated and is therefore functionally comparable. We anticipate following the pre-market pathway of current balloon dilators as a predicate. Our device would be considered a Class II medical device by the FDA. Recurring infantile esophageal strictures affect less than 200,000 people in the United States, and we anticipate that this product may qualify for a Humanitarian Device Exemption. This would simplify the regulatory process and reduce the pre-market costs.