February 4, 2010

Hospitals Dispute Medtronic Data on Wires

By Kelley Luckstein

Some leading hospitals are reporting failure rates for Medtronic Inc.'s fracture-prone defibrillator wires—including among young people—that are significantly higher than what the company has publicly disclosed…


Reports from hospitals including the University of Rochester in New York state, the Minneapolis Heart Institute, the Mayo Clinic and the University of Ottawa, say the overall failure rate for Sprint Fidelis leads is as much as two times as great as the company's own data indicate…


In November, a separate Mayo Clinic study showed the failure rate for Sprint Fidelis leads after two years was higher in patients younger than 50, at 20.4%, than in older patients, with a rate of 3.5%. There were 89 patients under 50 who received the leads, and 362 patients who were 50 or above. Medtronic said the Mayo study of fractures by age had an especially small sample size of younger patients, and thus is open to question.


Wall Street Journal, by Thomas Burton, 2/3/2010

Tags: Cardiology, Medtronic

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