NEWTOWN, Pa., May 27, 2021 /PRNewswire/ Micro Interventional Devices (MID) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its MIA-T Percutaneous
/PRNewswire/ Micro Interventional Devices (MID) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its MIA™-T.
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NEWTOWN, Pa., Jan. 28, 2021 /PRNewswire/
Micro Interventional Devices, Inc.™ (MID) announced today that it has submitted the required technical documentation for CE Mark approval for its MIA-T™ Percutaneous Tricuspid Annuloplasty System for tricuspid valve repair to its Notified Body. The receipt of a CE Mark would allow MID to commercialize MIA-T in the European Union in countries governed by the European Medical Device Regulations (MDR). MID is anticipating an approval in 2021. This will enable a treatment option for millions of patients currently at too high a risk to be treated with the standard of care, open surgical repair with cardiopulmonary bypass.