Stent maker to offer free replacements

Battling to keep its share of one of the world's largest medical-device market, Boston Scientific Corp. said yesterday that it would provide a free new Taxus coronary stent to any hospital treating a patient whose artery clogs around the device.

Starting in January, if a patient requires a procedure to reopen an artery within 12 months of having a Taxus stent put in, the company will provide the hospital with a free replacement, the Natick device-maker said yesterday.

A new stent costs up to about $2,500, depending on the hospital where it is implanted. The procedure to clear a coronary artery and implant the stent costs several thousand dollars more, which the company would not cover.

The Taxus stent, a tiny wire mesh tube coated with a drug to keep arteries from clogging, has fueled enormous growth for Boston Scientific since it was introduced in 2004. In the past several months, however, the company has struggled with a flow of data suggesting that patients who receive a Taxus stent are more likely to need their arteries re-cleared than patients with the rival Cypher stent, made by Johnson & Johnson.

''The bottom line is, it's a statement of confidence" in Taxus, Boston Scientific chief operating officer Paul LaViolette said yesterday. ''We're hoping every institution would consider taking advantage of it."

About 7.8 percent of patients with Taxus stents end up needing another procedure on the affected artery, compared with 5.1 percent of Cypher patients, according to a study published in the Journal of the American Medical Association in August.

Dr. Campbell Rogers, a cardiologist at Brigham and Women's Hospital, said the guarantee was ''intriguing" but questioned whether it would be practical for doctors and hospitals to reap the benefits. The terms of the deal require hospitals to pre-enroll with a Boston Scientific salesperson and submit multiple documents to prove the artery has reclogged inside the stent.

''It's not like returning your blender because it broke," said Rogers. ''It's certainly unprecedented -- I've never heard of such a thing in our field."

Rogers and other observers pointed to another aspect of the offer: Since a stent cannot be removed, a free-stent guarantee may imply that doctors should fix a clogged stent by installing a new one, which involves reopening the artery with a balloon device and implanting the new stent. That technique is often used by doctors, but has not been approved by the Food and Drug Administration.

LaViolette said the offer was not intended to prod doctors to fix a clogged stent by installing a new one.

There is ''absolutely no linkage," he said. ''We're obviously aware that we're not capable of promoting that."

The company has not estimated the cost of the new warranty program, a spokesman said, but LaViolette estimated that fewer than 1 percent of procedures would result in a claim.

Boston Scientific's stock, which has dropped steadily this year from a high of $35.19 in January, climbed 82 cents yesterday to $24.30.

A spokeswoman for Cordis, the stent-making division of Johnson & Johnson, said the company had no plans to offer a similar free-stent guarantee.

''We will only offer a performance guarantee that is consistent with the approved labeling of our product," said spokeswoman Terri Mueller.

With the two companies vying for an estimated $6 billion worldwide market, a fierce legal and marketing war has erupted between Boston Scientific, which says its Taxus stent can be more easily threaded into difficult arteries, and Johnson & Johnson, which says its Cypher keeps arteries clearer.

After the close of trading, Boston Scientific said it achieved a legal victory when a Dutch court said Johnson & Johnson violated a Boston Scientific patent on its stent delivery system.

The court barred Johnson & Johnson from making or selling its stents in the Netherlands, where it has a factory, LaViolette said.

Boston Scientific also is pursuing the claim in US and European courts.

A spokesman for Cordis said the company had not seen the decision and could not comment.

Stephen Heuser can be reached at sheuser@globe.com.