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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
Trade NameFlourish Pediatric Esophageal Atresia Device
Classification Namepediatric esophageal atresia anastomosis device
Generic Namepediatric esophageal atresia anastomosis device
Regulation Number876.5980
Applicant
WILSON-COOK MEDICAL INC.
4900 bethania station rd
winston salem, NC 27105
HDE NumberH150003
Supplement NumberS005
Date Received08/03/2020
Decision Date10/02/2020
Product Code
PTK[ Registered Establishments with PTK ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
New enrollment pas for the flourish pediatric esophageal atresia magnetic device: the study objective is for continued evaluation of device safety and probable benefit after device approval. This is a prospective, single-arm, new enrollment observational study conducted in a minimum of 15 sites, including 1 site in the united states. A minimum of 20 subjects will be followed for 2 years after treatment with the flourish pediatric esophageal atresia magnetic device. The frequency of follow-up assessments will be consistent with the standard of care. The primary safety endpoint is the rate of the following: stricture at the anastomotic site leading to the need for intervention; peri-anastomotic leaks; and other adverse events and/or complications potentially related to the device or procedure (including, but not limited to: gerd, tracheomalacia, esophageal dysmotility, and/or recurrent asthma or pulmonary infections). The secondary endpoint (for evaluation of probable benefit) is successful anastomosis formation, defined as creation of a lumen connecting the upper esophageal pouch to the lower esophageal pouch as demonstrated by union of the device magnets and an esophagram showing connected flow of contrast agent. Descriptive analyses will be presented for all study endpoints.
Post-Approval StudyShow Report Schedule and Study Progress
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