Device to Prevent Athletes' Brain Injury Wins FDA Nod

 

A simple-seeming neck collar can be marketed to prevent brain injury resulting from subconcussive head impacts in athletes, the FDA said Friday.

The Q-Collar is designed and sold by Q30 Innovations of Westport, Connecticut. It's a compressive device that fits around the sides and back of the neck. The idea behind it, according to Q30, is to squeeze the jugular veins in such a way as to produce "a temporary increase in intracranial blood volume." This, in turn, "results in an expansion of the venous structures within the skull," holding the brain "in a more stable state" that is less vulnerable to "sloshing" inside the skull as a result of impacts.

Repeated head blows that don't necessarily cause overt concussion have nevertheless been tied to long-term adverse neurological effects, including chronic traumatic encephalopathy or CTE.

The FDA based the authorization on multiple studies, including one conducted with a high school team that included 284 participants age 13 and older. About half the young athletes wore the collar in the open-label trial: MRI scans conducted at baseline and after a season of play showed that fewer of those who wore the collar developed significant white-matter changes, the FDA said in a news release.

Specifically, 73% of the no-collar control group showed white-matter alterations versus 23% of the players who wore the collar.

Q30 also worked with researchers at Cincinnati Children's Hospital, Walter Reed, and West Virginia University on published studies regarding the Q-Collar, according to the company's website -- studying populations of football, soccer, and hockey players. The evidence base in sum includes 15 peer-reviewed published studies.

The FDA is not authorizing the Q-Collar to prevent concussion or other serious brain injury, the agency noted, nor for those who have not been medically cleared to play contact sports.

The FDA encourages consumers to contact a medical professional to consult on whether wearing the Q-Collar could help "if a user is unsure."

"Today's action provides an additional piece of protective equipment athletes can wear when playing sports to help protect their brains from the effects of repetitive head impacts while still wearing the personal protective equipment associated with the sport," said Christopher M. Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health, in the agency's announcement.

The FDA reviewed the device through de novo premarket review, a regulatory pathway for new types of low- to moderate-risk devices.

Q30's chief medical advisor is Julian Bailes, MD, a neurosurgeon with NorthShore Medical Group (near Chicago), according to the Q30 site. Bailes is a long-time sports concussion researcher and team doctor with pro football's Pittsburgh Steelers, who was spotlighted in the 2015 movie "Concussion" (played by Alec Baldwin). Other Q30 advisors include Vernon Davis, a retired standout NFL tight end; Allison Kumar, a former FDA senior program manager; and Phil Phillips, a former FDA deputy director for medical devices.

The Q-Collar was previously OK'd for use in Canada and is now on sale there.

https://www.medpagetoday.com/sportsmedicine/generalsportsmedicine/91384