Guidant Halts Stent Delivery, Citing Quality

Guidant Corp. said Wednesday that it had suspended shipments of a new heart stent in Europe and stopped enrolling patients to test the product in Japan because of factory quality problems.

About 1% of Guidant’s drug-coated Xience stents made at its Temecula plant didn’t meet quality standards, the Indianapolis company said.

It did not say how many suspect stents were implanted, but said no patients were injured. Guidant said it would remove the devices from stockpiles and reduce first-quarter earnings by $15 million to write off inventory.

Stents are mesh tubes placed in blood vessels leading to the heart after blockages are removed. Drug coatings on many stents are intended to prevent new buildups. The $6-billion-a-year industry is dominated by Boston Scientific Corp. and Johnson & Johnson.

Guidant said it would delay the sale of Xience stents in 25 European countries until the third quarter. The product isn’t approved for U.S. marketing, although Guidant said it completed enrollment of 1,002 American patients for a clinical trial.