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Non-surgical aortic valve repair device approved
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The FDA announced approval of the first artificial aortic valve that can replace a valve damaged by senile aortic valve stenosis without requiring surgery, according to a press release.
The Sapien Transcatheter Heart Valve (Edwards Lifescience) is approved for patients who are not eligible for open-heart surgery for replacement of the aortic valve and have a calcified aortic annulus, according to an agency release. FDA officials noted that the product label advises that a heart surgeon should be involved in determining whether the device is appropriate.
The device is not approved for patients who are eligible for surgery, have congenital heart valve anomalies, have masses or an infection in their hearts, or cannot tolerate anticoagulation/antiplatelet therapy.
The approval was supported by data from 365 patients who were not eligible for surgery. Half of the patients were assigned to the aortic valve. Of those patients, 69% were alive after 1 year, compared with a 1-year survival rate of 50% among the other half of the patients, who received alternative non-surgical treatments including balloon valvuloplasty.
Death, stroke, perforation of the blood vessels, ventricle or valvular structures, damage to the conduction system in the heart, significant bleeding and leaks around the new valve were the most commonly reported adverse events associated with the device. Edwards Lifesciences will conduct post-market research on the device.
The valve is composed of cow tissue and polyester. The device is supported by a steel mesh frame. The replacement procedure involves catheterization via the femoral artery through to the diseased valve. When the valve is released from the catheter and expanded with a balloon, it is immediately functional.
For more information, visit the FDA website.
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