Summary From the Gastroenterology and Urology Devices Panel– January 17, 2003
On January 17, 2003, the Gastroenterology and Urology Devices Advisory Panel met to make recommendations on P020006, Enteric Medical Technology, Inc’s Endoscopic Implantation of Enteryx™ for the Treatment of Gastroesophageal Reflux Disease. This device is an injected polymer placed at the lower esophageal sphincter to prevent acid reflux. The Panel voted 6 to 0 in favor of a recommendation to approve the PMA with ten conditions. The approximate conditions outlined by the Panel were:
- A separate post-market study to be done as a placebo-sham controlled trial.
- The indication for use is changed to “The Enteryx™ procedure kit is indicated for endoscopic injection into the region of the lower esophageal Sphincter (LES) for the treatment of symptoms due to reflux disease (GERD) in patients responding to and requiring pharmacological therapy.”
- As part of a post market study, specific guidelines for re-treatment should be determined.
- Examine the data statistically by longitudinal events.
- Add precautions to not use the device in cases with esophageal strictures or patients refractory to pharmacologic therapy.
- Change the physician labeling to remove the requirement for prophylactic antibiotics and pain medications, remove the ban for spicy foods, and describe and add photographs to demonstrate the technique of injecting the device.
- Change the patient labeling to mirror the physician labeling.
- Specify in the labeling that the device is a permanent implant.
- State in the labeling that retreatment can be performed but the effects of retreatments are unknown.
- Remove the implied term “lifelong” from the labeling.
Contact: Jeffrey Cooper, D.V.M., Executive Secretary, 301-594-1220, x121
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Under normal circumstances, panel summary minutes are available 60-90 days post meeting. Summaries are also available on the CDRH website.