Boston Scientific fires at J&J study

Launching a salvo ahead of a big cardiology conference, a Boston Scientific Corp. executive yesterday said a closely watched study sponsored by rival Johnson & Johnson will fail to demonstrate the superiority of the latter's cardiac stents.

The two companies are slugging it out in the lucrative market for the tiny medical devices, which prop open arteries that have been unclogged.

The study, funded by Johnson & Johnson's Cordis division, is to be the largest head-to-head comparison of the latest versions of the stents, now with antiscar coatings. If the science shows a clear advantage for one brand, it could provide a marketing advantage.

A spokeswoman for Cordis said the company wouldn't discuss results of the study, known as Reality, until it is formally released on Sunday.

But Paul A. LaViolette, chief operating officer of Boston Scientific of Natick, said he's heard from doctors who participated in the study that it won't meet its goal of showing Cordis's Cypher drug-coated stent is superior to Boston Scientific's Taxus product.

''It was designed to show Cypher's superiority over Taxus, and it will therefore fail," LaViolette said. That's even though Cordis was in a position to ''skew the outcome" in how the trial was designed, he said.

The upshot is that the study isn't likely to affect Boston Scientific's total share of the roughly $4 billion annual drug-coated stent market in the United States, recently around 63 percent, he said.

''We will revert to a marketing battle over minor differences," he said.

Terri Mueller, the Cordis spokeswoman, declined to respond to LaViolette in detail and wasn't able to provide contact information for the European doctors running the study.

But Joseph Carrozza, a Beth Israel Deaconess Medical Center cardiologist who mainly uses Cordis's Cypher stents, said he expects some positive news from the study for Cordis, since the company is hosting lavish gatherings to discuss the results. ''I think both companies will get what they want out of it," Carrozza said.

In the technical world of medical devices, LaViolette's sharp comments would have been unusual just a few years ago. But as markets for stents, pacemakers, and other devices become more lucrative, sales practices are getting more cutthroat.

Drug-coated stents are a good example. Stents are tiny wire-mesh tubes used to prop open coronary arteries after they have been cleared of blockages through a procedure known as angioplasty. The coatings on the latest versions reduce the build-up of scar tissue that can require repeat procedures.

Boston Scientific captured two-thirds of this market from Johnson & Johnson last year, and lately the New Jersey medical products company has been trying price cuts and production increases to catch up.

The companies are also working on successor technologies, and Boston Scientific predicts it will start selling a new version of its stent in the United States within 18 months.

Cypher's development outlook is cloudy while parent Johnson & Johnson decides how it might integrate Cordis with the assets of another big medical devices company, Guidant Corp. of Indianapolis, which Johnson & Johnson is buying for $25.4 billion.

The presentation of results from the Reality trial and other studies will be the next skirmish, set to take place Sunday at a conference of the American College of Cardiology in Orlando, Fla. The trial follows the stents' performance in 1,386 patients treated at 89 centers in Europe, Asia, and Latin America.

LaViolette said he expects Johnson & Johnson to talk up advantages the study might show for the Cypher stents in certain patient populations, such as diabetics or those who require stents in harder-to-reach arteries.

But those conclusions won't be significant, LaViolette said, since the study was designed only to look at patients who could be treated with either stent. Since Reality selected out patients who would mainly benefit from Taxus, LaViolette said, it isn't likely to show all of Taxus's advantages.

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