Medtronic Inc.’s request to expand the use of defibrillators that synchronize the right and left chambers of the heart may need more discussion, a Food and Drug Administration staff report said today.
The FDA is concerned the studies used results from a subset of patients after the evaluation on the defibrillators was complete, the report said. An advisory panel is set to meet Dec. 7 on Minneapolis-based Medtronic’s application that the defibrillators be cleared for a milder form of heart failure than the condition the devices are approved to treat.
The defibrillators from Medtronic are approved for patients with moderate and severe heart failure who are fatigued or experience palpitations from below-normal amounts of physical activity or who can’t carry out tasks without discomfort. Some physicians already use the devices on lower-risk patients, so the market probably won’t grow significantly if expanded use is approved, said Joshua Jennings, a senior research analyst with Cowen & Co. in New York.
“I don’t expect it to be any type of windfall for Medtronic,” Jennings said in a telephone interview.
The classifications of heart failure were developed by the New York Heart Association.
Medtronic retrospectively selected a patient population for the supporting evidence, and the FDA said not all of the patients meet the criteria for the device’s proposed use. The results Medtronic will present on Dec. 7 are to supplement the original study the FDA and the company agreed on after the defibrillators failed to reduce the proportion of patients whose condition worsened in the original evaluation.
Medtronic rose 4 percent to $35.98 at 4 p.m. New York time.
The FDA approved expanding the use of Boston Scientific Corp.’s cardiac resynchronization therapy defibrillators in September 2010 for patients with mild heart failure, even when they have no outward symptoms. Physicians view the devices from Medtronic and Natick, Massachusetts-based Boston Scientific as similar, Jennings said.
A trial by Medtronic, the world’s largest maker of heart rhythm devices, showed cardiac resynchronization therapy is beneficial in patients with mild heart failure, the company said in an August 2009 statement. The study on 610 patients originally showed no statistical benefit after 12 months. A follow-up after 24 months on 262 patients in Europe showed the therapy reduced the need for hospitalization and shrank heart size, helping the heart pump more efficiently.