St. Jude Medical (NYSE:STJ) hit the worldwide "pause" button on implantations of its Portico transcatheter aortic valve implant, including in a U.S. trial and in Europe, where the replacement heart valve is already on the market.
St. Jude spokeswoman Candace Steele Flippin told MassDevice.com today that the company initiated the pause after CT scans turned up a potential problem with the valves in "a small number of cases." The issue, involving what Steele Flippin called "reduced valve leaflet mobility," was seen in patients after 4D CT scans at 30 days.
St. Jude is in the process of reviewing the 4D CT scans on the patients in its U.S. pivotal trial whose earlier scans turned up the potential problem, Steele Flippin said during a telephone interview.
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