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. |
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Trade Name | Flourish Pediatric Esophageal Atresia Device |
Classification Name | pediatric esophageal atresia anastomosis device |
Generic Name | pediatric esophageal atresia anastomosis device |
Regulation Number | 876.5980 |
Applicant |
WILSON-COOK MEDICAL INC. |
4900 bethania station rd |
winston salem, NC 27105 |
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HDE Number | H150003 |
Supplement Number | S005 |
Date Received | 08/03/2020 |
Decision Date | 10/02/2020 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | postapproval study protocol |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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