Tendyne Holdings, Inc.
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Latest From Tendyne Holdings, Inc.
Tendyne is indicated for the treatment of significant mitral regurgitation in patients who are not candidates for surgery. It complements Abbott’s MitraClip mitral valve repair device and is an important part of the company’s strategy to be the leading structural heart device company.
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.