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Percutaneous Mitral Valve Therapy: The Next Decade

After more than a decade, the field of transcatheter mitral valve therapy is still in its infancy, yet it is surprisingly crowded. The first percutaneous mitral valve company was founded in 1999, the same year that the first transcatheter aortic valve implantation (TAVI) company was founded, but while TAVI is now on the market in Europe and in the US, the leading transcatheter mitral valve therapy has only just completed clinical trials.

The past year witnessed two milestones in structural heart disease: the first US approval of a transcatheter aortic heart valve – the Sapien valve from Edwards Lifesciences Corp. – and the completion of the first ever randomized clinical trial for a percutaneous device for mitral valve disease, the MitraClip from Abbott Laboratories Inc.

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• By Elizabeth Orr

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• By Brian Bossetta

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• By Amanda Maxwell

Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?