Though it is not mandatory for the FDA to follow its advisory committees' advice, there have been many instances where it does. FDA voted 9-2 against the newly developed Chronicle Implantable Hemodynamic Monitor by a Minneapolis-based company.
The FDA's rejection was based on the studies carried out by Medtronic Inc. that suggested the device isn't effective. The Chronicle device is designed to monitor pressure inside the heart and alert doctors to heart-failure complications in patients before they worsen.
According to reports, the device keeps a track of heart rate, temperature, pressure and patient activity measurements. The data can then be downloaded by doctors in the office or securely transmitted to the Web for viewing.
AP quotes Dr. David M. Steinhaus, vice president and medical director of cardiac rhythm disease management as saying, "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."
Fridley-based Medtronic is the world's largest maker of electronic heart devices. The company is currently researching on a defibrillator that incorporates the monitoring technology. Thursday's decision was a key step toward starting sales of the device in the United States.
