The C-shaped device, called the Q-collar, fits around the back and side of the neck. It works by clamping the blood vessels in the neck, which increases the blood volume in the skull. It restricts the movement of the brain within the skull, which according to researchers generally causes traumatic brain injury.
The FDA said it based its recommendation on a number of studies, including one that compared changes in brain structure between high school football players wearing the Q-Collar and those who did not. All participants were 13 years and older.
The researchers used advanced imaging techniques to examine changes in the brains of nearly 300 study participants before and after the season. They found changes in the deep structures of the brain in 73% of the participants in the non-collar group, while no significant changes in the same structures were found in 77% of the participants in the collar group.
“Today’s action provides an extra piece of protective equipment that athletes can wear as they practice sports to protect their brains from the effects of repeated headaches while still wearing the personal protective equipment associated with the sport,” said Dr. Christopher M. Loftus said. director of the Office of Neurological and Physical Medicine Devices at the FDA’s Center for Devices and Radiological Health.
The data provided for the Q-Collar did not show that the device prevented concussion or serious head injury, the FDA said. And the Q-Collar should not replace other protective equipment related to sports activities.
The device will be sold directly to the consumer.