In 1997, the Harrison Fetal Bladder Stent Set was granted a humanitarian device exemption from the FDA. Cook Medical was the first manufacturer to receive FDA approval to market a humanitarian device. The stent set was designed to treat fetal postvesicular obstructive uropathy. Cook developed the set with renowned pediatric surgeon Dr. Michael Harrison from the University of California San Francisco. This set consists of a trocar needle, a wire guide, a stent, and a stent positioner. The set allows physicians to provide temporary drainage of the fetal bladder until the defect can be surgically repaired after birth.
Our EchoTip® amniocentesis needles and catheters allow physicians to aspirate fluid from the amniotic sac. Along with trocar needles and chorionic villus sampling sets, our products meet physicians’ needs for fetal intervention and genetic testing. To view our range of amniocentesis needles click here.