The U.S. Food and Drug Administration (FDA) last week approved the CareLink Monitor, made by Minneapolis-based Medtronic Inc. Heart patients who have implanted defibrillators will, for the first time, be able to send information to their doctors over the Internet, completely bypassing cumbersome office visits.
"Up until now, the only way we could get the information was to have the patient come into the office, which is often a problem because these patients have frequent issues and have to come back and forth to the hospital," says Dr. Larry Chinitz, director of Cardiac Electrophysiology at New York University Medical Center. "This is really a natural progression. It's really a very, very positive move forward.""This will open up an entirely new way for physicians to treat patients with chronic disease, and it's a great option for patients who want and need to stay connected with their doctors," Steve Mahle, president of Medtronic Cardiac Rhythm Management, says in a statement. "This is a true marriage of medicine and technology."
Some 1 million heart patients around the world work, play, and sleep with implanted defibrillators, not to be confused with pacemakers. The devices are generally given to patients who have very fast heartbeats, have survived sudden cardiac arrest, are at risk for life-threatening arrhythmias or have an arrhythmia that causes them to pass out. When they were introduced in the early 1990s, implantable defibrillators gave doctors sudden access to a wealth of information about patients' conditions. Before that, such data was available only with costly, time-consuming and laborious in-patient testing.
With the implanted defibrillators, explains Chinitz, "patients come to the doctor's office, put a magnet on and download a tremendous amount of information about their hearts -- rhythm disturbances, how well the device is functioning, the battery's end-of-life, events that have to be treated."
The new system goes one step better.
"Now if someone has a funny feeling, they can call the doctor and just do it on the phone," says Chinitz. "Patients have to be followed every three or four months, and the new system will give you a complete data set since the last interrogation."
The CareLink system consists of a portable monitor equipped with an antenna, which will download information from the implanted defibrillator and send it to a secure server via a toll-free telephone number. The procedure is much like the one most of us use to access our e-mail using a modem. The secure server receiving the data is also connected to the Internet, and doctors and other health-care professionals can access the information from any computer. For a small fee, patients can have their own Web site where doctors can access patient information. All Internet access will require passwords.
For now, CareLink will serve only patients who have Medtronic GEM II DR/VR implantable cardioverter-defibrillators, but the application will soon extend to pacemakers, heart-failure devices and monitoring diagnostic devices. The CareLink system will be rolled out to 10 clinical centers around the country this month, and is expected to be available nationwide in February. Company officials are still negotiating with insurance companies, but they say the service should be covered much like an office visit.