Posted by Michael Wonder on 19 Jan 2021
Occlutech's atrial flow regulator receives U.S. FDA breakthrough device designation for heart failure
19 January 2021 - Occlutech announced today that the U.S FDA has granted the Company a breakthrough revice designation for its first in class, implantable atrial flow regulator for heart failure patients with preserved or reduced ejection fraction.
The atrial flow regulator is for use in patients with heart failure with preserved ejection fraction or reduced ejection fraction and who, despite optimal medical therapy, experience worsening symptoms.
