Med Device Monday: Flourish Esophageal Atresia and Humanitarian Devices

1 in 2,500 babies in the United States are born with esophageal atresia, a congenital defect in which the upper and lower parts of the esophagus don't properly connect in utero. Typically, affected infants have problems with eating and require a feeding tube until they're large and stable enough to have surgery performed to connect the esophagus. 

A device approved in May of 2017, Flourish Pediatric Esophageal Atresia Device, offers a different, less invasive, and innovative new solution. Flourish uses two magnets to slowly connect the two parts of the esophagus. As they explain, "Over the course of several days, the magnets gradually stretch both ends of the esophagus, after which the tissue connects to form an intact esophagus. To date, 16 patients have been successfully treated with this device."

The magnets are inserted through catheters in the mouth and via the abdominal wall, as shown:

Photo from 

Photo from 

It's important to note that the device cannot be used in patients with tracheoesophageal fistula, a condition commonly found in those with esophageal atresia. However, if a fistula has been repaired, Flourish can be used. Additionally, of the 16 treated patients, 13 required a follow-up procedure to fix narrowing of the newly formed esophagus. Notably, this is a complication that is common with the traditional surgical repair as well. 

What makes this innovative device even more special is that was granted approval from FDA via the Humanitarian Use Device (HUD) pathway. A HUD is defined as a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year (thanks to the 21st Century Cures Act, the population estimate was changed from "fewer than 4,000" to "not more than 8,000" this past December). In order to pursue approval via this pathway, an application is filled out and submitted to FDA. It's somewhat similar to a Premarket Approval Application (PMA), but does not have the effectiveness requirement of a PMA. However, it "must contain sufficient information for FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. Additionally, the applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that they could not otherwise bring the device to market."

In 2007, title VIII of the Food and Drug Administration Amendments Act (FDAAA) included a provision that all applications via the Humanitarian pathway are required to include certification that all applicable clinical trial information has been submitted to the data bank. 

You can check out the list of FDA's approved Humanitarian Devices on their website.



Further reading:

RAPS article about Flourish

FDA press release about Flourish