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MADITMulticenter Automatic Defibrillator Implantation Trial
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NATICK, Massachusetts, September 29, 2010 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today welcomed the publication of an analysis of long-term data from the MADIT II clinical trial in the current issue of Circulation.
Analysis of the first MADIT, which included patients at extremely high risk for SCD, showed that ICD therapy costs about $27,000 per life-year saved, while a cost analysis of the MADIT-II trial with a lower risk population showed a cost for one patient of $43,200.
Takanori Ikeda of Toho University in Tokyo presented the results of the prospective study of 82 consecutive MADIT II type patients with mean follow-up of 2 years.
Finally, we excluded all subjects (n = 33) who had indications other than ischemia for placement of an ICD and studied the remaining 165 patients who represented the MADIT II population.
At the same time, implantable defibrillator systems, led by the VENTAK(R) PRIZM(TM) family, continue to benefit from the wide acceptance of the results from the MADIT II trial," said Dollens.
A few private insurers have begun accepting and paying for ICDs for MADIT II-type patients, but it is not a widespread practice.
The MADIT II trial was a prospective, randomized, multi-center study that enrolled more than 1,200 patients in 71 centers in the United States and five European centers.
The MADIT II trial of patients with disease-weakened hearts found that individuals with implanted defibrillators lived longer than the group on medical therapy alone.
Findings from the MADIT II trial were so convincing that an independent review panel decided that the device's effectiveness no longer needed to be proven because it had clearly demonstrated the lifesaving benefits of ICDs.
Reduction in the risk of heart failure with preventative cardiac resynchronization therapy: MADIT - CRT Trial.
If implantable defibrillators cost $20, I would say the MADIT II study would have been more than sufficient" to warrant immediate coverage for all post-MI patients with low LVEFs.