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Medtronic stent criticized by study
The study questioned claims of effectiveness, but the lead investigator said the results may have been skewed.
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Medtronic Incorporated's drug-coated heart stent Endeavor had more complications than Johnson & Johnson's rival device to prop open arteries and didn't reduce the need for future treatment, a study has found.
The research presented at the Transcatheter Cardiovascular Therapeutics conference in Washington, D.C., raises questions about Endeavor's safety, which had been considered the device's edge in the intense battle for the $4 billion worldwide market for drug-coated stents. Fridley-based Medtronic is trying to revive Endeavor's sales, which slumped after Abbott Laboratories' Xience won U.S. approval in July and captured half the American market.
"Medtronic has done a good job promoting its safety, and this certainly calls that into question," said Alexandra Lansky, director of the Women's Health Initiative at the Cardiovascular Research Foundation, in an interview after she moderated a news conference about the findings Thursday.
Lansky, a cardiologist at New York-Presbyterian Hospital-Columbia University Medical Center, said she would no longer choose Endeavor as a first option for her patients based on what she called the "sobering results."
The study, with two others presented Thursday at the conference, is continuing and may have been skewed by blood-thinning drugs or by sicker patients receiving Medtronic's version of the mesh sleeves aimed at keeping arteries open, said Jens Flensted Lassen, lead investigator in the trial, named Sort-Out III.
Medtronic's shares fell 83 cents, or 2 percent, to $40.01. The company sank 15 percent after the study was presented, then rose with the overall market.
The study results aren't likely "a major game-changer" because of the caveats, said Rick Wise, a Leerink Swann & Co. analyst in New York, in a note to clients.
Still, the research is likely to cost Medtronic sales, said Jan David Wald, a Stanford Group Co. analyst in Boston, in a telephone interview.
"To the extent that Medtronic has been making such a strong claim on safety, you know it can't help them, and it can't make investors and doctors feel more confidence about using their stent," Wald said.
"These data are interesting, but they are far from extraordinary proof," said Daniel Beach, a spokesman for Medtronic, in an e-mail.
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