FDAnews
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ST. JUDE DEVICE EFFECTIVE IN TREATING STROKES

October 19, 2005

A recent clinical trial shows that a St. Jude device is effective in treating a condition associated with thousands of strokes annually. The study included 67 patients at five research sites in Europe.

The trial showed that St. Jude's PFO (patent foramen ovale) CLOSE UP (Closure Using Premere) device was able to close 87 percent of PFOs after six months without adverse events. PFOs are common defects where a small hole between the upper chambers of the heart can allow unfiltered venous blood to enter the arterial circulation. If that blood contains a clot or other debris, it can cause a stroke. That condition is associated with 200,000 strokes annually, the company said.