FDA OK for St. Jude to Resume Portico TAVR Trial

Today St. Jude Medical announced FDA approval to resume their U.S. IDE trial for the Portico Transcatheter Aortic Valve System. The trial had been put on pause back in September 2014 due to safety concerns. According to St. Jude's press release (below) both a company and independent review of the data have concluded that this reduced leaflet mobility is "a class effect," seen in all TAVR devices, as well as surgical valves.

Source: News from Angioplasty.Org - June 4, 2015 Category: Cardiology Source Type: news