Boston Scientific to Reveal Key Heart Stent Data

After months of playing it close to the vest, Boston Scientific Corp. will show its cards next week when it unveils results of a clinical trial for a drug-coated stent that may give rival Johnson & Johnson a run for its money.

Boston Scientific on Monday will reveal results of a U.S. trial for its Taxus stent, a wire mesh tubes used to prop open coronary arteries after fatty deposits have been cleared surgically. A number of medical device companies are now adding drug coatings to retard scar tissue formation and consequent restenosis, rendering the procedure more effective, especially in complex cases.

Johnson & Johnson, first in the U.S. market for drug-coated stents since winning approval in April, recently cut prices for its Cypher stent in anticipation of the Taxus launch, analysts said.

“The temporary monopoly J&J has on drug-coated stents is likely to soon end,” said analyst Alex Arrow of Lazard Freres & Co. “We get to see what that competition is going to look like and how strong that will be at this meeting,” Arrow said.

Analysts believe the devices will eventually generate billions of dollars in annual sales.

Boston Scientific, based in Natick, Massachusetts, in June filed for U.S. Food and Drug Administration approval of its Taxus stent, an indication the results are likely positive. The company has launched the Taxus stent in Europe and other regions while it awaits U.S. approval, expected later this year.

Heart specialists gathering in Washington next week at the Transcatheter Cardiovascular Therapeutics meeting will compare results from Boston’s Taxus IV clinical trial with J&J’s pivotal trial, called Sirius.

Roxana Mehran, director of clinical research at the Cardiovascular Research Foundation, which sponsored the meeting of more than 10,000 specialists, said J&J has set a high bar with its Cypher stent, which achieved a restenosis rate of just 8.9% in vessels treated with the device in the Sirius trial.

She said Boston Scientific will need to achieve a comparable rate to be considered competitive.

Lloyd Kline, director of clinical services in cardiology at Rush-Presbyterian-St. Luke’s Medical Center in Chicago, is betting the Taxus results will be positive.

“Whether or not it will be good enough to make the stock market happy, I don’t know, but I do believe it will be enough to make physicians happy,” Kline said. “If it turns out that it is almost as good or as good and is a lot cheaper, in this environment, that is all that will be necessary,” he said.

Cardiologists next week also will get a look at early data on drug-coated stents from cardiovascular giants Medtronic Inc. and Guidant Corp. and Abbott Laboratories Inc., which have been slower to develop the devices than J&J or Boston Scientific.

Mehran said the more competitors in the drug-coated stent market, the better for patients. “Competition is good. It drives prices down and makes products available to everyone.”