Take Home Message: FDA's charge to evaluate device safety can be accomplished without the slowness of the approval process. I have patient's frankly dying as they wait for this device which has taken 5 years longer to approve here than in Europe, Canada & Australia. Pendulum needs to swing back.
In November, FDA approved the Sapien Transcatheter Heart Valve, for treatment of severe aortic valve stenosis. The Sapien valve can be implanted from the groin artery without surgery. It's a boon for patients who are too sick to endure open-heart surgery. Clinical trials found that almost 70% of patients receiving Sapien valves were alive one year after treatment, while only 50% of those without replacement survived that long.
This would be a great story for Americans, but for one frustrating detail: The Sapien valve has been available in Europe since 2007, saving lives there but not here. Today, Americans wait as much as 60% longer than they did in 2005 for new lifesaving and life-enhancing medical devices—such as stents & defibrillators—to reach the market, according to a GAO report.