Medtronic wins FDA approval for its Internet-based cardiac monitoring system

By Alicia Ault

NEW YORK (Reuters Health) – Medtronic Inc. on Wednesday said that it had won US Food and Drug Administration (FDA) approval for its CareLink Network, a monitoring and software package that will let physicians receive data via a Medtronic Web site from patients who have implantable cardioverter-defibrillators (ICDs).

The FDA only approved the system for the GEM II DR/VR implantable ICD, which is worn by 23,000 patients. But Medtronic hopes to quickly receive additional approvals for the other implantable cardiac devices it has on the market, including pacemakers, heart failure devices, and other types of defibrillators, said company spokesman Scott Papillon.

The company can't say when CareLink will be commercially available, or how much it will cost, said Papillon. But Medtronic plans to sell individual patient monitors and software packages to physicians, and possibly charge a per-use fee. Doctors may be able to bill insurers the cost of a follow-up visit each time they access the patient's data. Initially, 10 pilot sites will work with Medtronic to assess the system.

"I think the utility is going to be enormous," said George Crossley, director of electrophysiology at Baptist Hospital in Nashville, TN, and a Medtronic adviser. Crossley and his colleagues have been pleased with tests conducted with the CareLink network on its patients.

The system will give patients peace of mind because they can quickly determine with their doctors if they've had an event and what to do about it, he told Reuters Health. And thanks to the data they'll receive, physicians can adjust therapy without requiring an office visit that might be inconvenient, he added.

Patients collect information from their implanted devices by holding a small wand over their chest, which receives the data by radiofrequency signal. The wand is attached by wire to a console-like monitor that transmits the downloaded and encrypted data via a conventional phone line to a Medtronic-maintained secure server.

Physicians or other authorized users log onto the Medtronic Web site, and get access to their patients' information after entering a password. The data for defibrillators will include everything a physician would see in a conventional office visit, including tracking of rhythm disturbances or shock episodes, said Papillon.

The doctors can access the information from any place they can log onto the Internet, so they could check up on patients when they are traveling or at home.

Patients also will be given their own password-protected Web sites so they can check information posted by their physicians, such as battery life of their implanted device, instructions, or general health information.

"In addition to being a tremendous convenience for patients and clinicians, we believe CareLink will give patients security and peace of mind about their devices," said Steve Mahle, president of Medtronic Cardiac Rhythm Management in a company statement.

CareLink won't eliminate the need for periodic office visits, said Medtronic.

Crossley agreed and said that the system had the potential to make practices more efficient. But, he said, if physicians aren't properly reimbursed for the phone and computer time, they might be less likely to adopt the technology.

In Wednesday trade on the New York Stock Exchange, shares of Medtronic closed down1.15 at 50.

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