Guidant Corp., Indianapolis, said it might have to delay filing for a key government approval for a new type of drug-coated heart stent that the company hopes will help it regain its competitive edge.
A market leader in sales of bare-metal stents, Guidant has been developing a new generation of drug-coated stents that would be absorbed by the body. But issues related to the metal portion of the stent could require changes in its production or design, the medical device maker said Wednesday.
If the design does need to be altered, Guidant said it might have to delay by up to six months its filing for a government permit needed for tests that must be held before it seeks approval from the Food and Drug Administration to sell the device.
Changes in production methods still would allow for the filing in June, Guidant said. The company said it expects the issues to be resolved by the end of the year.
Dana Mead Jr., president of Guidant's vascular intervention unit, said today a six-month delay in the filing was a "worst-case scenario."
Guidant said it still expects to market the Champion stent, which uses a bioabsorbable polymer, and was confident in the product based on clinical trials and preclinical testing.
"I think we have a good handle on the issue," Mead said, adding that Guidant expects to provide updated information in about a month.
The company hopes to bring the Champion stent to the U.S. market early in 2006, about a year after it forecasts the product will hit the market in Europe.
Shares in Guidant fell 11% Wednesday after the company announced the possible delay but ended up 44 cents to $54.05 in trading today on the New York Stock Exchange.