FDA advisors agreed with St. Jude Medical Inc. that its Amplatzer patent foreman ovale occluder has benefits for select patients that outweigh the risks for recurrent strokes, at a Circulatory System Devices Panel meeting. However, many of the advisors at the May 24 meeting in Gaithersburg, Md., also pointed to the need for continuing medication with anti-clotting agents for patients implanted with the device. (See Also see "St. Jude Hopes Its PFO Occluder Gets RESPECT At May FDA Panel" - Medtech Insight, 12 April, 2016..)
The panel voted 11-5 that benefits outweigh the risks with use of Amplatzer, and had a closer, 9-7 vote in...