FDA approves pig heart valve for humans
The U.S. Food and Drug Administration in Rockville, MD, recently approved marketing clearance for an artificial heart valve made from pig tissue. This pioneering pig-tissue valve, the Toronto SPV, is the first of its kind to be marketed stentless, or without a plastic or metal cuff around the opening attaching it to the heart muscle.
By avoiding the need for a stent, the Toronto SPV valve allows blood to flow through it more effectively and may make it more durable, according to the valve's manufacturer, St. Jude Medical Inc. of St. Paul, MN. In addition, a spokesperson for St. Jude Medical says the stentless valve may last longer because it works more like a real valve and puts less stress on itself.
Artificial valves are implanted in the human heart when its natural valves wear out. There are two kinds: mechanical and tissue. Mechanical valves are usually made from long-lasting metal or carbon, while tissue valves are derived from pigs, whose hearts are anatomically similar to human hearts.
Overall, tissue valves work more efficiently than mechanical ones, but they do have their drawbacks. For example, tissue valves tend to calcify, or harden, which results in more frequent replacement, as well as less frequent use in younger patients, the company said.
The estimated worth of the United States tissue valve market is $150 million, the spokesperson says.
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