The FDA's approval of the valve is based on a study of 365 patients with the condition who weren't eligible for open-heart surgery. Half of the patients received the artificial valve while the other patients received alternative treatments, such as one that enlarges the aortic valve opening by stretching it with a balloon.
Patients who received the new valve did have eight times as many vascular and bleeding complications and 2.5 times more strokes than those who did not receive the valve. However, patients who received the valve were also more likely to be alive one year after surgery than those who received an alternative treatment -- 69 percent versus 50 percent, respectively, the investigators found.
The most common serious side effects associated with the artificial valve and its implantation include death, stroke, perforation of blood vessels or ventricular or valvular structures in the heart, significant bleeding, leaks around the new valve, and damage to the heart's conduction system, which is responsible for a consistent and healthy heart beat.
Another cardiologist called the device's approval "important news."
"Often these patients are elderly with numerous other medical ailments that make standard aortic valve surgery too risky to perform," said Dr. James Slater, director of the Cardiac Catheterization Lab at NYU Langone Medical Center in New York City. "Medical [drug] therapy is generally not effective and the availability of a therapy that is less invasive and traumatic than standard surgery is an important advance," he added.
Slater also hopes that "further improvements in these devices will decrease the rate of complications and that further investigations will allow this therapy to be available to a wider range of patients with this disease."
California-based Edwards Lifescience, which makes the new valve, says it will continue to eva
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