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Tongxin Medical's first-ever clinical trial of a fully magnetic levitation artificial heart for children worldwide has been approved by the U.S. FDA
Tongxin Medical’s wholly-owned US subsidiary BrioHealth Solutions announced that the company has received conditional approval from the U.S. Food and Drug Administration (FDA) to initiate clinical evaluation of the BrioVAD system for pediatric patients with advanced heart failure.
The Brio4Kids trial, as an extension of the INNOVATE trial into the pediatric field, will be conducted under the research device exemption (IDE) of the latter.
This not only marks the first prospective clinical trial of a fully magnetic levitation artificial heart for pediatric patients, but also the first time the same left ventricular assist device (LVAD) has been simultaneously evaluated in both adult and pediatric populations, filling a gap in the treatment of childhood heart failure.
(Jiemian News)