This head impact collar that cuts athlete brain injuries just got the FDA nod

Chris Davies - Feb 26, 2021, 12:02pm CST
This head impact collar that cuts athlete brain injuries just got the FDA nod

An innovative collar intended to prevent athletes from suffering brain injury from head impacts has been given authorization by the FCC to go on sale in the US, with hopes that Q-Collar could help the millions of such injuries that happen each year. Traumatic brain injury (TBI) can lead to nerve damage, paralysis, and even death, when blunt trauma causes the brain to “slosh” in the skull.

According to the National Institute of Neurological Disorders and Stroke, there are potentially as many as 3.8 million TBIs that are blamed on sports and recreation in the US every year. It’s been of particular concern around young people playing football, where incidents involving striking, or being struck by, another person or object can lead to such damage.

Developed by Canadian company Q30 Innovations, Q-Collar takes a physical route to try to reduce TBIs. Designed to be worn tightly around the neck, it applies pressure to the internal jugular veins. In turn, that increases the amount of blood volume in the blood vessels found in the skull.

That increase of pressure in the skull is key, since it acts as a cushioning element around the brain. “Typically, when people experience blunt trauma accidents, the brain moves unrestrained in the skull, which is known as a “slosh,” the FDA explains. “The Q-Collar’s increase in blood volume in those blood vessels creates a tighter fit of the brain inside the skull and reduces the “slosh” movement.”

It’s not been a quick path to authorization. Q-Collar was first submitted to the FDA in May 2020, seeking authorization to market the device in the US under the Administration’s De Novo classification. That’s a special regulatory pathway for new devices considered to present low- to moderate-risk.

That doesn’t mean it didn’t have to satisfy the Food and Drug Administration that the evidence was in the wearable’s favor. A study in the US with 284 subjects – aged 13 years or older – on high school football teams saw 139 athletes wearing a Q-Collar during the season, and 145 not. An accelerometer on each player measured head impacts sustained.

Pre- and post-season magnetic resonance imaging (MRI) scans were used to create Diffusion Tensor Imaging of the athletes’ brains, which could be used to assess any structural changes sustained over the season. 73-percent of those who did not wear a Q-Collar showed significant changes in the deeper, white matter regions of the brain, which are involved in the transmission of electrical nerve signals.

In comparison, only 23-percent of those athletes who wore a Q-Collar showed such changes. “These differences appear to indicate protection of the brain associated with device use,” the FDA said today. “No significant adverse events were associated with device use.” While the study used footballers, Q-Collar’s designers say it’s suitable for any sport where potential head impact could be encountered.

It’s not a magic bullet, of course, and it doesn’t prevent the need for other safety equipment like helmets and pads, or indeed the potential need for stronger regulations covering the safety of young athletes. There’s also a lengthy list of conditions that could preclude Q-Collar’s use, such as known seizure disorders, people with existing high pressure in the skull, blood clots, or skin injuries or rashes around the neck. Q-Collar can only be worn for up to four hours at a time, and is designed to be replaced at least every two years.

Still, given the number of TBIs sustained each year, and the potential for lifelong repercussions or even death, it could be an important addition to an athlete’s locker. The Q-Collar is currently sold at CA$249 ($186), with different sizes available depending on neck size. The company has not yet announced US pricing.


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