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INDIANAPOLIS -(Dow Jones)- Guidant Corp. (GDT) said the Multi-center Automatic Defibrillator Implantation Trial was terminated early due to significantly improved total survival rates among heart attack survivors who received an implantable defibrillator compared with those who received conventional treatment.
In a press release Tuesday, Guidant said a data and safety monitoring board terminated the MADIT II study because implantable defibrillators dramatically lowered mortality - a 30% reduction - among sudden cardiac death in patients who have survived heart attacks and have weakened hearts.
The MADIT II trial was a prospective, randomized, multi-center study that enrolled more than 1,200 patients in 71 centers in the U.S. and five European centers. The study was supported solely by a research grant from Guidant. Complete study findings will be published in the near future.
Sudden cardiac death, which claims the lives of nearly 400,000 Americans annually, is the abrupt loss of heart function, usually due to a potentially fatal electrical rhythm dysfunction called ventricular fibrillation, the company noted.
Under current FDA-approved indications, 300,000 patients each year in the U.S. are eligible to receive an implantable defibrillator. Guidant said it plans to apply for an expanded indication to the FDA which, if approved, could potentially double the eligible patient population.
New York Stock Exchange-listed shares of Guidant closed Tuesday at $46.82, up 41 cents or 0.9%, on volume of 2.22 million shares.
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