FDAnews Device Daily Bulletin
Medical Devices / Research and Development

Edwards Lifesciences Drops Centera TAVR for Sapien 3

July 26, 2019
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Edwards Lifesciences has jumped ship on its Centera transcatheter aortic valve replacement (TAVR), citing high costs of development and a greater interest in developing its Sapien 3 valve.

“While the CENTERA valve has demonstrated excellent clinical outcomes and is performing well for patients, the time and resources required to optimize deliverability as well as expanding the indications to match the Sapien 3 valve are significant,” the company said.

Notably, the decision comes just weeks after the devicemaker issued an urgent field safety notice for the Centera system. Edwards reported challenges in tracking and manipulating the device around the aortic arch that led to vascular injury and death in some cases.

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