INDIANAPOLIS (AP) - Guidant Corp. (Editor's note: Guidant Corporation is a corporate undewriter for Heart1.com) said it might have to delay filing for a key government approval for a new type of heart stent that the company hopes will help it regain its competitive edge.
Shares of the Indianapolis-based medical device maker dipped following the announcement Wednesday.
The company has been a market leader in sales of bare-metal stents - tiny metal scaffolds inserted in heart arteries to prop them open after surgery to clear blockage. But the company has lagged competitors in introducing drug-coated stents that reduce the problem of reclogging of arteries from tissue buildup.
Guidant has been developing a new generation of drug-coated stents that would be absorbed by the body. Last year, it spent about $45 million in separate deals with two California-based companies for technology related to the absorbable stent.
The company hopes to bring its Champion stent to the U.S. market early in 2006, about a year after it forecasts the product will hit the market in Europe.
Guidant projects the global market for drug-coated stents to reach $6 billion a year by 2006.
In a news release Wednesday, Guidant said that there were issues related to the metal portion of the stent that could require changes in production or design of the new device.
Guidant said it still expects to market the stent using the bioabsorbable polymer and said it was confident in the product based on clinical trials and preclinical testing.
If design changes prove necessary, the company said it might have to delay by up to six months filing for a government permit needed for tests that must be conducted before seeking approval from the Food and Drug Administration to sell the device.
Changes in production methods still would allow for filing in June, Guidant said. The company said it expects the issues to be resolved by the end of the year.
Guidant officials said they would provide an update on the new stent during a conference call with investors and reporters that already had been scheduled for Thursday morning.
Guidant shares closed down nearly 7 cents, or about 11 percent, at $53.70 on the New York Stock exchange following the announcement Wednesday.
Guidant was spun off from Indianapolis-based drug maker Eli Lilly and Co. in 1994. Most of Guidant's 12,000 employees are in Minnesota and California.
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