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Continued: FDA panel approves Medtronic's new stent

  • Article by: CHEN MAY YEE , Star Tribune
  • Last update: October 10, 2007 - 9:30 PM

Weinberger, who ended up voting for FDA approval, initially was skeptical.

"Lack of evidence is not evidence of lack," he said. "If I had my druthers, we'd be sitting here evaluating the data 12 to 18 months down the line."

Controlled conditions

He also noted that, while slight renarrowing of arteries didn't lead to more cardiac deaths or heart attacks during the trial, those patients had been overseen by highly trained doctors. It's not clear if the results might differ "in the hands of an average interventionist," he said.

Others pointed out that, even if the data didn't answer all questions, it was still a lot more information than regulators were able to review before previous recommendations concerning stents.

"I'm incredibly impressed" by the number of patients followed over three years, said Dr. David Naftel, professor of surgery at the University of Alabama in Birmingham. "If you're looking at data in four years," he said, "we got nothing."

As a condition for approval, the panel said that Medtronic should study at least 5,000 patients over five years after the device is on the market to track blood clots, heart attacks and cardiac deaths. It also added a second condition: Medtronic must recommend on its label the use of Dual Anti-Platelet Therapy -- a combination of aspirin and a second anti-clotting drug such as Plavix -- according to medical guidelines, which are currently 12 months.

Medtronic shares were up 88 cents, to $57.73, in late trading Wednesday.

After attending the meeting, a Boston Scientific official emphasized the lack of long-term safety data for Endeavor.

"Many physicians may want to wait for more data and patients may want to, too," said Jeff Mirviss, vice president for marketing for Boston Scientific. He said that his company is presenting five-year data concerning Taxus at a cardiology conference in Washington that starts Oct. 20.

Chen May Yee • 612-673-7434

Chen May Yee •

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