COOK REVIEWING OPTIONS FOR FETAL STENT DISTRIBUTION FOLLOWING PANEL VOTE AGAINST APPROVAL OF THE DEVICE; DATA ON 40-50 MORE PATIENTS SUGGESTED
This article was originally published in The Gray Sheet
Executive Summary
The Cook Group is reviewing its options for bringing the Harrison fetal bladder stent to the market following a recommendation by FDA's Obstetrics and Gynecology Devices Panel against approval of the device at a July 23 meeting in Gaithersburg, Maryland. Cook is undecided whether it will pursue collection of the additional clinical data recommended by the panel, which could take at least a year to gather.