The Edwards Lifesciences Triformis Resilia is the first dedicated surgical tricuspid valve on the market cleared with data from off-label use of mitral valves.
FDA clears first surgical valve of its kind | Family files $17M lawsuit | BATMAN to the rescue | Major trends at SCCT 2026
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![A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]](https://cardiovascularbusiness.com/sites/default/files/styles/media_thumbnail/public/2024-09/istock-1209664264.jpg?itok=d9hdApI9)
