Breakthrough status to preeclampsia deviceJune 9, 2019
Targeted Apheresis Column for Preeclampsia (TAC-PE) has been granted a Breakthrough Device Designation by the USFDA, Advanced Prenatal Therapeutics announced.
The device specifically removes disease-causing factors such as sFlt-1 from the mother’s blood. It is intended to treat preeclampsia, a leading cause of prematurity and maternal/foetal death, and holds the potential to substantially reduce mortality, incidence or severity of preterm birth, and the use of neonatal intensive care.
The company is now preparing for initial clinical studies using the device.
The FDA grants Breakthrough Device Designation to devices that provide more effective treatment of life-threatening or irreversibly debilitating diseases. Devices must also represent a breakthrough technology, treat a disease where no approved alternatives exist, offer significant advantages
over existing approved alternatives, or otherwise be in the best interest of patients.