FDA Green-Lights Resumption Of St. Jude TAVR Study
This article was originally published in The Gray Sheet
St. Jude stopped the U.S. pivotal trial of its Portico transcatheter aortic valve in September after computed tomography found evidence of a possible leaflet mobility problem. But it has restarted after further studies have found no clinical events associated with leaflet motion and evidence that the leaflet-thickening is just as likely to affect surgical aortic valves.
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