St. Jude Halts Portico TAVR Implants Based On IDE Study Imaging Data
This article was originally published in The Gray Sheet
The firm says it is temporarily halting implants of its transcatheter aortic health valve replacement worldwide while it reviews CT data showing reduced valve leaflet mobility in some patients treated as part of St. Jude’s U.S. pivotal trial.
You may also be interested in...
St. Jude Medical’s Portico transcatheter aortic valve is poised to become more competitive in Europe in 2014 as more sizes become available, executives told investors during the firm’s Feb. 7 annual investor conference. And the firm is talking to FDA about alternative pivotal trial designs.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
A review by a government watchdog found the FDA’s review process for COVID-19 diagnostics was plagued by issues including allowing low-quality tests to slip through, high reviewer workloads, and manufacturer frustration.