Occlutech's Atrial Flow Regulator for Heart Failure Receives ... | 合法醫療器材資訊網

2021年1月27日—TheAFRisusedinpatientswho,despiteoptimalmedicaltherapy,experienceworseningsymptoms.TheAFRmaintainsaninteratrialshuntwith ...

January, 27, 2021 — The U.S. Food and Drug Administration (FDA) has granted Occlutech a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF)[1] patients with preserved (HFpEF) or reduced (HFrEF) ejection fraction.

The AFR is used in patients who, despite optimal medical therapy, experience worsening symptoms. The AFR maintains an interatrial shunt with a predetermined diameter allowing for controlled blood flow from the left to the right atrium enabling the left atrium to decompress and lower left atrial pressure. Reduced left atrial pressure has been shown to reduce heart failure symptoms and improve exercise tolerance.

Breakthrough Device Designations[2] aim to accelerate the development, assessment, and approval of new treatments in severe diseases, including a prioritized review all the way through market...