Boston Scientific recalls heart stents

Boston Scientific Corp. said yesterday it is recalling a large number of its drug-coated cardiac stents, which have been among the fastest-selling medical devices in history, after reports of a death and serious injuries related to the devices.

The recall raised health concerns among doctors, and several major hospitals decided to stop implanting the stents.

The Natick company extended a voluntary recall to 85,000 of the 500,000 Taxus stent systems, which went on the market in the United States in March. It was the second recall this month. The company said it has received reports linking the drug-coated Taxus stents to one death and 18 serious injuries. The company also said that it is aware of two deaths and 25 serious injuries associated with an earlier stent system known as Express2 and that is recalling 11,000 of the 600,000 it has shipped.

Patients who already have received the recalled stents are not at risk, doctors said yesterday. Blaming production problems, the company said the problems lie in the system used to implant the stent inside an artery. Stents are small, wire-mesh tubes used to prop open clogged arteries, and are put into place through a procedure known as angioplasty.

At least two major hospitals have stopped using Taxus stents, which are considered a major advance because they are coated with drugs that reduce scar tissue, which can reclog the blood vessel. Brigham and Women's Hospital in Boston said it halted use of Taxus stents as of Thursday evening.

''We took the stents off the shelf out of old Yankee conservatism," said Campbell Rogers, director of the hospital's cardiac catheterization laboratory.

Beth Israel Deaconess Medical Center made the same decision yesterday afternoon. ''We're going to take the products off the shelf until we can be convinced that they have identified and corrected the problem," said Joseph Carrozza, Beth Israel's director of interventional cardiology. ''I'm not so sure they really know what the problem is at this point. They said they knew what the problem was two weeks ago," he said, referring to the company's first recall of 200 stents earlier this month.

Other hospitals also are evaluating whether to continue using the devices. Igor Palacios, director of interventional cardiology at Massachusetts General Hospital, said, ''This will raise the question of how broad this is going to be and whether they will pull out the entire system."

The recall is a serious stumble for Boston Scientific. The medical device firm grew into the state's biggest life sciences company over the past year, as its stock rose based on the potential of Taxus. The company says it has dethroned rival Johnson & Johnson as the leader in the $3 billion drug-coated stent market. So far, the two companies are the only ones with drug-coated stents on the market.

Johnson & Johnson also suffered production problems as it rolled out its Cypher drug-coated stent last year. In October 2003, the Food and Drug Administration issued an advisory linking the stents to more than 60 deaths, but said the rate was in line with the expected rate and declined to issue a formal warning to doctors.

Boston Scientific said that the recall will reduce its second-quarter sales by $45 million and that it will write off $50 million of inventory. It will release more data with its second-quarter financial results on July 26.

''The situation, while obviously something we're not happy about, is not a complete catastrophe," said Boston Scientific chief executive James R. Tobin. Because the company can ship replacement stents, he said, ''We're in an enviable position to be able to respond to this."

Yesterday morning, Boston Scientific halted trading without explanation. Trading resumed at about 3:45 p.m. after a hastily organized conference call with analysts to discuss the recall. Shares finished the day at $37.40, down $3.09 from their close Thursday.

A Boston Scientific spokesman said the company halted trading while finalizing its news release regarding the recall.

The FDA's district office will monitor the recall and the company's communications with doctors and patients about the issue, said Gladys Rodriguez, director of enforcement for the FDA's Office of Compliance.

Taxus stents arrive in a compressed state, wrapped around a tiny balloon. Surgeons thread the device into a patient's coronary artery and then inflate the balloon with a burst of saline pressure. The balloon is deflated and withdrawn, leaving the expanded stent behind. Boston Scientific has reported problems with Taxus stents in which the balloon does not properly deflate, making it difficult to remove, sometimes requiring emergency surgery.

The company first described the problems with Taxus publicly in April and quickly instituted changes to the balloon design. On July 2, it said it would recall 200 Taxus systems it already had shipped. They were part of production batches in which the hole between the catheter and balloon was too small, apparently because the plastic material was stretched during a laser-welding process used in manufacturing.

The company also began reviews of other batches, including Express2 bare-metal stents, and yesterday said it could not vouch for their safety.

The company has previously disclosed other reports of cases in which the balloons seemed to stick to the cardiac stents, perhaps because of the drug coating, and were hard to withdraw. It did not specify the number of adverse events linked to the problem, which is also under FDA review.

Ross Kerber can be reachedat kerber@globe.com. JeffreyKrasner can be reached atkrasner@globe.com.