A Food and Drug Administration advisory panel unanimously recommended the expanded use of one of
The FDA's Circulatory System Devices Panel voted 8 to 0 to expand the user labeling for the company's cardiac resynchronization therapy defibrillators to cover patients with advanced heart failure.
But the unanimous approval of the device, which was announced Wednesday night, was in question earlier this week, when the panel said the Companion trial, a 1,520-patient study backing Guidant's application to expand use of the defibrillators, was difficult to interpret.
In the Companion trial, which was published in the
New England Journal of Medicine
two months ago, Guidant measured the chances that a patient using one of its devices would be hospitalized vs. a patient treated with drugs alone. When the study began, Guidant measured hospital admissions, but it switched to hospital stays in excess of 24 hours while the trial was ongoing, prompting the FDA panel to express reservations about the study's quality.
The panel's recommendation is the "result of an exhaustive review of the data generated by this important study. Companion results demonstrate the value of cardiac resynchronization therapy defibrillators in a broader group of heart failure patients," said Fred McCoy, president of Guidant's cardiac rhythm management unit. "We now look forward to the Food and Drug Administration's final decision."
According to Guidant, as many as 35,000 new patients a year would be able to use its heart devices if the FDA acts on the advisory panel's recommendation, a decision that is expected to come this year.
Shares of Guidant fell 43 cents, or 0.8%, to $52.77, giving back some of the 4.6% gain shares have had since Monday on rumors that
Johnson & Johnson
is considering acquiring the company.