FDA Approves “First-of-its-kind” Infant Medical Device

The U.S. Food and Drug Administration (FDA) recently authorized the use of what it described as a “first-of-its-kind” medical device to treat infants for a birth defect called esophageal atresia, in which the upper esophagus is disconnected from the lower esophagus and the stomach. According to the FDA, babies with this condition require a feeding tube until surgery can be performed to connect the esophagus to the stomach.

According to Cook Medical, its pediatric esophageal atresia anastomosis device, called Flourish™, uses magnets to pull the upper and lower esophagus together, closing the gap and allowing food to enter the stomach. Dr. Mario Zaritzky, a pediatric radiologist at the University of Chicago Medical Center and one of the joint inventors listed on the patent on this technology (U.S. Patent No. 9,168,041), states:

“The idea was to create a minimally invasive procedure that could possibly be an alternative to surgery in selective pediatric cases. Any procedure that can potentially replace major thoracic surgery with a less invasive method should be considered before deciding to go to the operating room.”

Cook Medical’s press release notes that each of the 16 infant patients treated using this device had a successful joining of their esophagus with no remaining gap, within 3‑10 days after receiving the device.

According to the Cook Group, Cook Medical is a company that engages in “medical research and product development in minimally invasive medical device technology for diagnostic and therapeutic procedures.”

Chang Lim
Chang Lim is an associate in the firm's Orange County Office. Chang practices intellectual property law, with a focus on patent counseling and protection of electronics and software technologies. During law school, Chang served as an editor of the Journal of Law and Public Policy. Prior to joining Knobbe Martens, he was an associate at an intellectual property boutique law firm in New York.
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