FDA Wants Heart Procedure Answers

The FDA has stopped promotion of expensive implants that seal shut a little hole in the heart, the Associated Press reported.

The defect, called patent foramen ovale, affects one in five adults, though most will never know it. The FDA is pushing implant manufacturers to settle the issue of whether the hole is harmful and whether fixing it helps prevent certain strokes and migraines.

Studies comparing the $23,000 implants to stroke-fighting drugs are going on now. Until this week, the FDA had allowed two manufacturers, Boston, MA-based NMT Medical and AGA Medical of Golden Valley, MN, to market implants domestically for repeat-stroke sufferers, under a special rule that lets promising devices for rare conditions sell before there’s final proof that they work.

But with closure no longer rare, the FDA has withdrawn that special approval, urging the two manufacturers to finish their studies and tightening, slightly, how stroke patients get the devices in the meantime.