FDA Panel Rejects Medtronic Chronicle Heart Monitor
March 2, 2007 by Lei
Filed under Diseases & Conditions
Just two years ago, Medtronic reported positive results from a study of the Chronicle implantable hemodynamic monitor (IHM). The Chronicle IHM is designed to continuously monitor pressure within the heart, body temperature, patient activity, and heart rate in patients with heart failure. That information is then relayed to the doctor’s office using a standard phone line where any problematic indicators would alert the healthcare provider. Treatments can then be adjusted before the patient got sick enough to need hospitalization.
Unfortunately, federal health advisors recommended against FDA approval of the Chronicle IHM yesterday. The data did not show that patients experienced a significant reduction in heart failure-related hospitalizations, emergency department, and urgency care visits. Results from the COMPASS-HF study of 274 patients showed a 22% reduction in these types of healthcare needs, but the panel was not impressed.
The University of Kentucky Odyssey has personal profiles of patients who’ve received the Chronicle IHM. Heart failure patient Susan Levy received one of the devices and said:
My symptoms are not always the same as other people’s. Sometimes I appear to be dehydrated when I am actually overloaded on fluids and need to get rid of water. This device tells my doctors what is happening. I haven’t had to go to the hospital since I’ve had it. I don’t think I would have survived without it.
They push me to have quality of life. I’m basically having a wonderful life. If I have a problem, I call them, and they tell me what to do. The Chronicle has given me my life back. I can do anything I want to now. It has been a miracle.
So what’s next for patients like Mark Herpel?
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Tags: medtronic, chronicle, ihm, implantable hemodynamic monitor, heart failure, heart, heart disease, diseases, illness, health, medicine, medical devices
