FDA: Hazardous to Your Health

October 8, 2011
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When people age, the main valve carrying blood out of the heart becomes brittle. As this aortic valve narrows, it can cause debilitating heart failure, and even death. Fixing the problem in the United States requires open-heart surgery. In Europe, the problem can be repaired using a tiny catheter that introduces a replacement valve through an artery in the leg. In July, a Food and Drug Administration advisory panel said this device should also be approved for sale in the U.S.

When people age, the main valve carrying blood out of the heart becomes brittle. As this aortic valve narrows, it can cause debilitating heart failure, and even death. Fixing the problem in the United States requires open-heart surgery. In Europe, the problem can be repaired using a tiny catheter that introduces a replacement valve through an artery in the leg. In July, a Food and Drug Administration advisory panel said this device should also be approved for sale in the U.S. It is expected to reach patients by year end—more than four years after it first hit the market in Europe.

…more than 15,000 patients world-wide will receive the device by the time it’s slated for approval in the US. Some Americans healthy enough to fly have sought the procedure in Europe. Tens of thousands of Americans unable to travel, and too sick to undergo open-heart surgery; have died during the intervening four years.

See Scott Gottleib editorial in the Wall Street Journal