The FDA has granted breakthrough designation for Auctus Surgical's vertebral body tethering scoliosis treatment.
Auctus Surgical's VBT system has a non-fusion approach and provides a viable, flexible option to complex fusion surgery, according to an Aug. 11 news release. Auctus' system utilizes an external magnet controller for non-surgical adjustment of the spine over time.
Breakthrough designation will allow for priority review and interactive communication with a device's development.
The company also received a U.S. patent for the system.