Braincool: Studie kommer inte påverka marknaden för kylning av hjärtstopp
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GermanyUnited-statesMartin-waleijஜெர்மனிஒன்றுபட்டது-மாநிலங்களில்Credit: PolarCool
LUND, Sweden May 11, 2021 PolarCool AB (publ), a Swedish medical device company focusing on treatment of sports-related traumatic brain injury (TBI) and whiplash, today announced that it has submitted a 510(k) pre-market notification to the U.S. Food and Drug Administration (FDA) for the PolarCap® System.
This submission follows publication of statistically significant clinical results in the scientific journal
Concussion, showing clear benefit for use of the PolarCap® System in the treatment of concussions among players of 15 elite Swedish Ice-Hockey teams in the Swedish Hockey Leagues (SHL).
The incidence of sports-related concussions is a significant national health concern in Sweden, as it is here in the U.S., and there is growing evidence that repetitive traumatic brain injury can cause long-term changes in brain structure and function. This is of particular concern in the field of contact sports, such as ice hockey, where available treatment options a
Sweden
Swedish
Johan-hemlin
Martin-waleij
Erik-andersson
University-of-technology
Lund-university-at-sk
Swedish-hockey-league
Drug-administration
University-hospital-in-lund
Swedish-ice-hockey
Swedish-hockey-leagues