Trémedics Medical Devices Gains Breakthrough Designation for Prenatal Stent

The FDA has granted Trémedics Medical Devices Breakthrough Device designation for its  Illusicor polymer-based prenatal stent.

The stent, which is designed to treat narrowing of the aorta in infants and children up to age 14, is  resorble, meaning that it gradually breaks down in the body, but has comparable strength to metal stents.

In preclinical tests, the stent was found to have long-term biocompatibility and to degrade fully, permitting vessel growth afterwards, the North Richland Hills, Texas-based company said.