Minnesota-Based Firm Gets Approval to Sell Tissue Heart Valves in U.S.
Posted on: Tuesday, 9 August 2005, 12:00 CDT
Aug. 9--If you can't beat them, join them.
St. Jude Medical, the dominant maker of mechanical heart valves, said Monday it has won regulatory approval to sell tissue heart valves in the United States.
The U.S. Food and Drug Administration has approved the Little Canada-based medical device maker's Biocor and Biocor Supra replacement heart valves, which use stents to help keep the shape of the devices intact. The devices, which are made of animal tissue that are treated for use in humans, replace diseased heart valves that fail to generate normal blood flow.
Sales of St. Jude's mechanical heart valves, the device upon which the company was founded 29 years ago, have been held back in recent years by the increasing popularity of animal tissue valves harvested from pigs or cows.
In fact, tissue valves now account for about 60 percent of all valves sold. One reason for the shift is that patients who get mechanical valves need to take blood thinners to keep them unclogged. On the other hand, an offsetting factor in the shift is that tissue valves tend to wear out faster than mechanical ones.
St. Jude is a distant third in a $350-million market for valves made with animal tissue that is dominated by Edwards Lifesciences, which has about 63 percent of the world market, and No. 2, Fridley-based Medtronic Inc., with 35 percent. With the approval to sell in the U.S., St. Jude can increase its tissue valve sales by 50 percent, going from a 2 percent market share this year to a 3 percent share next year of the overall market, said Thomas Gunderson, a securities analyst with Piper Jaffray Cos. in Minneapolis.
"Valves are a good business that were a big part of St. Jude's success in the 1980s and 1990s," Gunderson said. "But the valves have little impact on their growth."
Wall Street views St. Jude's growth as primarily tied to its cardiac rhythm management business in which the implantable cardiac defibrillator (ICD) is the key catalyst, Gunderson said.
The company's shares dipped 4 cents to $46.36 in trading Monday.
St. Jude expects to introduce the valves in the U.S. by the end of next month.
This story contains material from Bloomberg News and the Associated Press.
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Source: Saint Paul Pioneer Press (St. Paul, Minn.)
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