FDA Issues Safety Notification for Bioprosthetic Aortic Valves

On October 5th, the U.S. Food and Drug Administration (FDA) issued a safety notification involving bioprosthetic valves, including both SAVR and TAVR devices. The agency said it was aware of some instances where there was reduced leaflet motion in some devices. The FDA stated that the reduced leaflet motion was identified through advanced imaging studies. Patients who had the reduced leaflet motion did not show signs of abnormal bioprosthetic valve function. “Further, these studies have shown that in valves with reduced motion of one or more individual leaflets, there was acceptable forward blood flow through the valve opening without evidence of stenosis.” the FDA said.

The exact cause of reduced leaflet motion is unknown. According to the FDA notification, imaging studies suggest that the reduced motion may result from blood clot (thrombus) deposits on the leaflets. Patients under anticoagulation therapy with warfarin had a lower rate of restricted motion compared to those receiving sub-therapeutic or no anticoagulation and patients given dual anti-platelet therapy. In one study, the leaflet motion issues were resolved using anticoagulants.

SAVR devices have been on the market for 30 years and TAVR devices have been on the market for 8 years. The FDA says based on a favorable benefit/risk profile observed, it “believes that bioprosthetic aortic valves remain reasonably safe and effective when used according to their approved indications.”

from Parker Waichman http://www.yourlawyer.com/blog/fda-issues-safety-notification-for-bioprosthetic-aortic-valves/