J.&J. Says It Is Cleared to Offer New Products

Johnson & Johnson said on Thursday that its Cordis unit, which makes cardiovascular devices, has resolved its issues with the Food and Drug Administration, clearing the way for the introduction of new products.

Cordis, best known for its Cypher drug-coated heart stent, has been operating under a warning from the F.D.A. since April 2004. Regulators cited problems with internal procedures, including many issues with manufacturing processes.

Resolving the issues with the F.D.A. means the company can now introduce the next generation of its Cypher stent, a tiny, tubular device that props open diseased arteries and delivers drugs to the site to prevent the vessels from clogging again.

The Cypher stent competes in the United States with the Taxus drug-eluting stent by Boston Scientific. Medtronic and Abbott Laboratories are expected to introduce similar products in the United States over the next few years.

But the use of such devices, initially hailed as revolutionary, has declined over the last few quarters amid controversy that they may pose serious risks of deadly blood clots.

And drug-eluting, or coated, stents, which have been lucrative for the manufacturers, came under fire when a study suggested the devices were no better than standard drug treatments in reducing deaths and heart attacks in patients with minor chest pain.

Cordis said the penetration of drug-eluting stents was down to the mid-60 percent range as of April, from a peak in the mid-80 percent range a few years ago.

Shares of Johnson & Johnson rose 27 cents, to $62.45. Shares of Boston Scientific rose 35 cents, to $16.49.

SOURCE: REUTERS