10 large hospitals resuming Taxus use

Half the hospitals that had halted use of Boston Scientific Corp.'s blockbuster Taxus cardiac stent after a partial recall have started to use them again, the company said.

About 20 cardiac catheterization facilities had turned to a competing product from Johnson & Johnson after Boston Scientific's July 16 recall of 85,000 drug-coated Taxus stent systems and 11,000 of an earlier version after the devices were linked to three deaths and 43 injuries.

Stents are used to prop open clogged arteries, and hospitals that stopped using Taxus included several influential facilities such as the Brigham and Women's Hospital in Boston and Chicago Medical Center. But both of those sites and about eight others have since resumed using the stent, said doctors there and Boston Scientific spokesman Paul Donovan.

Several doctors said they regained confidence in the Taxus stent after the Natick medical devices firm reassured them that it had fixed the manufacturing glitch that prompted the recall. After the recall, Boston Scientific sent out nearly 300 representatives to make that case to doctors nationwide.

''Boston Scientific appears to have performed a very detailed root cause analysis of the problem and has identified the issue," said Jeffrey J. Popma, the Brigham's director of interventional cardiology.

In a presentation to doctors on July 28, Boston Scientific senior vice-president Paul A. LaViolette made a strong case that the company had a handle on the problem without trying to make it sound like a sales pitch, Popma said.

''The people he was in front of weren't in the mood to have anything sold to them," Popma said.

David P. Faxon, chief of cardiology at Chicago Medical Center, a teaching hospital associated with the University of Chicago, said it has also resumed using Taxus after visits from Boston Scientific.

''We feel reasonably satisfied in the changes in manufacturing they have made," Faxon said.

Taxus, which began selling in the United States in March, is one of only two drug-coated stents on the market. Coating a stent with a drug is considered a major advance because it reduces scar tissue build up that can lead to repeat procedures. To date, more than 500,000 Taxus stents have been implanted at nearly 1,200 large cardiac catheterization centers. Patients who already have them aren't affected by the recall.

Before the recall, Taxus captured more than 70 percent of the drug-coated stent market, according to Boston Scientific. It fell to as little as 55 percent following the recall, which is now complete in the United States but continues in Europe. Yesterday, Donovan said Taxus holds about 60 percent of the market.

''We have been working closely with hospitals around the country to provide information and answer questions," said Boston Scientific's Donovan. ''We're pleased that many of these hospitals are using Taxus again."

Stents are inserted after a common procedure called angioplasty. But in some cases, the balloons used to place the Boston Scientific stents didn't deflate properly, making them hard to remove and prompting the recall.

Despite Boston Scientific's full-court press, other doctors say they will still only use Johnson & Johnson's Cypher drug-coated stent until the Food and Drug Administration says more about Boston Scientific's actions. These include physicians at Boston's Massachusetts General Hospital and Beth Israel Deaconess Medical Center.

''For us, we would have to see a longer period of time where a lot of these stents are placed and there are no problems," said Joseph Carrozza, Beth Israel's director of interventional cardiology. ''We're taking probably the most conservative approach here."

He added that the hospital may not resume using Taxus for another three or four months.

Boston Scientific still faces questions about another complaint by doctors, that the balloons used to implant the Taxus stent seemed to stick to the device and were hard to withdraw. While the so-called ''stickiness" issue has been reported more often than the nondeflates, it hasn't led to any major injuries, Boston Scientific says.

Stock analysts have pressed Boston Scientific on unconfirmed reports of continuing complaints about balloons that didn't deflate. The company says it knows of three more reports of nondeflates since its recall on July 16, but said at least two of those balloons came from lots that were on the recall list and shouldn't have been used. It is still investigating the third report, Donovan said.

Shares in Boston Scientific closed at $37.27 in trading yesterday, up 74 cents. They had fallen from a close of $40.49 a share on July 15, just before the recall was announced to close as low as $33.27 on July 22, before recovering.

Ross Kerber can be reached at kerber@globe.com.