Genesis MedTech Announces FDA Breakthrough Device Designation for the J-Valve™ Transfemoral System
Genesis MedTech, a leading medical device company, announced that the US Food and Drug Administration (FDA) has designated its J-ValveTM Transfemoral (TF) System as a Breakthrough Device. This innovative heart valve has received Breakthrough Device designation for the proposed indication of treating severe native aortic regurgitation (AR) and AR-dominant mixed aortic valve disease in patients deemed eligible for the device and at high risk for open surgical aortic valve replacement by a heart team.
This revolutionary technology is intended for patients suffering fr...