Cephea Valve Technologies
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Latest From Cephea Valve Technologies
The new indication covers functional mitral regurgitation, also known as secondary mitral regurgitation, which represents two-to-three times as many patients as the primary mitral regurgitation population MitraClip is already labeled for. The approval is supported by results from the COAPT trial, the first randomized trial to show that a mitral-valve repair could improve outcomes in patients with secondary mitral regurgitation.
Abbott has exercised an option to buy Cephea Valve Technologies, developer of a minimally-invasive replacement heart valve, for an undisclosed sum.
A jury recommended a $70m award to Edwards Lifesciences unit CardiAQ based on findings that another firm, Neovasc, breached a supplier contract and used CardiAQ's trade secrets to develop a competing transcatheter mitral valve device.
Physicians and manufacturers alike expressed serious concerns with a proposal from White House advisors to make some hearing aids available over-the-counter and exempt from the Quality System Regulation at a recent FDA workshop. They argue the plan could endanger consumers without significantly lowering device costs.