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FDA OKs Wireless Monitor Heart Device

January 4, 2002

FRIDLEY, Minn. (AP) _ In a boon to remote health management, the Food and Drug Administration has approved a wireless system from Medtronic Inc. that allows heart patients to provide data from defibrillators implanted in their chests to physicians via the Internet, the company said.

``There is nothing out there with this type of Web connectivity,″ said U.S. Bancorp Piper Jaffray analyst Thomas Gunderson.

``Medtronic has been focused as a product company,″ said Christopher O’Connell, vice president and general manager of Medtronic’s patient-management division. ``Now we are going into a whole new era of post-implant services.″

Although two million people have implanted Medtronic heart devices, the FDA approval will affect only about 23,000 of them immediately. Those patients have Medtronic’s GEM II DR/VR defibrillator, which can now be monitored by the company’s fee-based patient management network, called CareLink. A defibrillator treats irregular heart rhythm.

CareLink is an Internet-based patient management system that allows doctors to evaluate a patient with an implantable cardiac device over the Internet.

To use the system, a patient uses a small wireless receiver to download diagnostic data from the cardiac device. That data is then transfered via a regular dialup connection to Carelink. Physicians log into the system to evaluate patient data.

Over the last two years, Medtronic has invested about $30 million in CareLink, which will be marketed to cardiology clinics and academic medical centers. Those clinics will pay an as-yet-undetermined annual fee to Medtronic for each patient. Patients, in turn, be asked to pay a fee to the clinics.

Analysts said the FDA is likely to approve other defibrillator models and some other heart devices for Web monitoring in the next year.

The CareLink network can support other heart devices _ pacemakers, heart-failure devices and diagnostic devices _ as the FDA approves the network’s use with them. The devices don’t need any special adjustments in order for heart-related data to be transmitted through the Internet.

Gunderson expects the network to help Medtronic defend and expand its leading market-share in cardiac-rhythm management devices. In fiscal 2001, Medtronic had $2.3 billion in cardiac-rhythm management sales _ 42 percent of total company revenue.

Medtronic isn’t the only company forging ahead with such Web-monitored medical technology.

In October, the FDA approved a remote, real-time pacemaker monitoring system designed by Biotronik Inc. A transmitter in that pacemaker sends data to a cell phone-like device that in turn makes a cellular phone call to a Biotronik central computer. The computer then downloads the data and faxes it to the doctor’s office.

UBS Warburg analyst David Lothson has estimated that by 2006 the Medtronic remote-monitoring network will be used by 150,000 patients and generate $250 million a year in revenue.

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