FDA Panel Rejects Medtronic Heart Monitor Device

Federal health advisers recommended Thursday that the government not approve Medtronic’s implantable device designed to detect worsening heart failure, according to the Associated Press.

The recommendation to the FDA against the Minneapolis, MN-based company’s Chronicle Implantable Hemodynamic Monitor came on a 9-2 vote. The FDA isn’t required to follow its advisory committees’ advice, but it does so most of the time.

A study of the device, made by the medical device manufacturer suggested it isn’t effective.

The Minneapolis-based company’s device works by taking heart rate, temperature, pressure and patient activity measurements. The data can be downloaded by doctors in the office or securely transmitted to the Web for viewing.

Medtronic is studying a defibrillator that incorporates the monitoring technology.

“We continue to believe in the benefit of this sound technology and intend to work in close collaboration with the FDA to define the appropriate path for approval,” said Dr. David M. Steinhaus. He is Medtronic’s vice president and medical director of cardiac rhythm disease management.