FDA OKs Cook Medical Device Developed in Winston-Salem
By Barry Teater, NCBiotech Writer
A medical device developed by Cook Medical’s endoscopy business unit in Winston-Salem is now being used to help newborns avoid surgery to repair a rare birth defect of the esophagus.
Cook recently received authorization from the U.S. Food and Drug Administration (FDA) to market the device, called Flourish, for the treatment of pediatric esophageal atresia.
The device uses rare-earth magnets that are inserted into the upper and lower ends of an infant’s esophagus where they gradually stretch the esophagus over several days. This allows tissue to connect and form an intact esophagus.
“We’re very excited that FDA has acknowledged the importance of Flourish as a minimally invasive alternative for pediatric patients with esophageal atresia,” Barry Slowey, president and global business unit leader for Cook Medical’s endoscopy business unit, said in a news release. “This technology has the ability to provide a different approach to treatment for those infants who suffer from this condition, as well as for their parents and families.”
To date, 16 patients have been successfully treated with the device, the company said.
“The idea was to create a minimally invasive procedure that could possibly be an alternative to surgery in selective pediatric cases,” said Mario Zaritzky, M.D., a pediatric radiologist at the University of Chicago Medical Center, who collaborated with Cook Medical to develop the device. “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.”
The device received a Humanitarian Use Device (HUD) designation given by the FDA to devices that treat or diagnose a disease or condition affecting fewer than 4,000 individuals in the United States per year. To receive this type of authorization, a company must demonstrate safety and probable benefit.
Esophageal atresia is a birth defect of the esophagus, the tubular structure connecting the mouth to the stomach. The upper portion of the esophagus does not connect to the lower portion of the esophagus and stomach.
Surgery has traditionally been the only treatment option to repair the malformation until Cook Medical developed this magnet-based approach.
Cook Medical, a family-owned business founded in 1963 in Bloomington, Ind., sells minimally invasive medical devices in 41 medical specialties. The company makes 16,000 products that serve 13 hospital lines in 135 countries.
The company has 12,000 employees worldwide, including 640 at the endoscopy unit in Winston-Salem.