Deans' stroke musings: FDA grants breakthrough device designation to hypothermic therapy for concussion

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Saturday, November 20, 2021

FDA grants breakthrough device designation to hypothermic therapy for concussion

Previous hypothermia research for stroke showed no definitive evidence in clinical studies. WHOM will be responsible for testing this out for stroke? Specific names only since we have NO STROKE LEADERSHIP to go to.

FDA grants breakthrough device designation to hypothermic therapy for concussion

The FDA has designated a novel, noninvasive hypothermic therapy device designed to reduce concussion symptom severity as a breakthrough device, according to a press release.

The device, pro2cool, was developed by TecTraum Inc.

Girl with concussioon — Source: Adobe Stock

“We are extremely proud to have TecTraum recognized by the FDA as a leader in concussion therapy as we work to commercialize the first-ever FDA approved treatment for concussions,” TecTraum CEO John Zak, MD, MBA, said in a press release. “Although our initial focus is on filling an unmet medical need for athletes, we anticipate demonstrating in the future that people who suffer concussions caused by falls, motor vehicle accidents or through military service also can benefit from the pro2cool medical device.”

Research has shown a link between significant improvements in clinical outcomes and cooling of the brain within days of a concussion. Pro2cool offers localized cooling for the head and neck to reduce blood temperature before it enters the brain.

With pilot studies having been completed, TecTraum will soon complete a large multisite pivotal clinical trial to evaluate effectiveness, safety and tolerability of pro2cool among patients aged 12 to 21 years, according to the release.

FDA grants marketing authorization for stroke rehabilitation device
Concussions, head impact exposure occur most often in football preseason, practices

“The FDA has provided input on the design and implementation of the trial,” Joseph Congeni, MD, director of sports medicine at Akron Children’s Hospital and lead principal investigator of the multisite pivotal trial of pro2cool, said in the release. “We all recognize that concussion is a growing burden — clinically, financially and emotionally — in the U.S. Based on previously published data, we are hopeful that our current trial will demonstrate the efficacy, safety and tolerability of this noninvasive treatment for mild traumatic brain injury, also known as concussion.”