FDA Clears the World's First Completely Automatic Pacemaker from Medtronic; Device Automatically Adjusts Pacing Energy Levels without Physician Intervention.

Business Editors/Health/Medical Writers

MINNEAPOLIS--(BUSINESS WIRE)--March 15, 2004

Medtronic, Inc. (NYSE:MDT), the world's leading manufacturer of implantable medical devices, today announced U.S. Food and Drug Administration (FDA) clearance and U.S. commercial launch of the world's first fully automatic pacemaker for slowly beating hearts. The Medtronic EnPulse(TM) system is the first-ever medical device to regularly measure the minimum energy needed to stimulate the heart's upper and lower chambers and automatically adjust the intensity of electrical impulses delivered to both chambers without physician intervention.

With other pacemakers, physicians manually measure and update device threshold levels during in-person patient appointments. In contrast, the EnPulse device can automatically adjust the level of pacing on an hourly or daily basis, which may help patients feel better and minimize the amount of time patients spend in a physician's office. Approximately 250,000 Americans receive pacemakers each year.

An earlier version of the EnPulse pacemaker was cleared by the FDA on Dec. 18, 2003. Now, physicians can use the device with a pioneering feature called Atrial Capture Management (ACM), which enables the pacemaker to automatically adjust electrical impulses delivered to the heart's upper right chamber (atrium). This device is the first pacemaker in the world to include ACM. The EnPulse pacemaker with ACM has been available in Europe since October 2003.

In addition, the FDA has approved the use of the EnPulse pacemaker with the Medtronic CareLink(R) Network, the company's Internet-based, remote cardiac device monitoring system. To date, the service has been used by patients with various Medtronic implantable cardioverter-defibrillator (ICD) models, and the company plans to make the service available in the next couple of months to many pacemaker patients whose clinics currently use the Medtronic CareLink Network. The Medtronic CareLink Network enables patients to transmit device information from home or while traveling instead of making trips to the clinic for device evaluation. Physicians review the data on a secure Internet website and, if needed, make adjustments to the patient's medication or prescribe additional therapy.

"The EnPulse is the first pacemaker capable of performing a complete set of diagnostic tests without human intervention," said Steven Compton, M.D., electrophysiologist at Alaska Heart Institute in Anchorage. "Use of this new technology should dramatically improve the ease of patient and device follow up. With this technology, in concert with the Medtronic CareLink Network, we hope to provide the highest level of device follow up to patients, including to those who live in the remotest areas."

The Medtronic EnPulse system incorporates an array of unique features to help physicians improve pacing therapy and streamline the patient follow-up process, including:

-- Atrial Capture Management (ACM): This exclusive feature

enables the automatic adjustment of the pacing impulse level

for optimal stimulation of the heart's upper right chamber

(atrium). It is the pairing of ACM with Ventricular Capture

Management, a similar function that may optimize stimulation

in the heart's lower right chamber (ventricle), that enables

the EnPulse device to automatically and regularly adapt to

necessary threshold levels in both chambers of the heart.

-- Post Mode-Switch Overdrive Pacing: With advanced sensing and

detection capabilities, the device automatically recognizes

and responds to potential atrial tachyarrhythmia (AT) triggers

with specialized therapies that may reduce the onset or

continuation of AT episodes, including atrial fibrillation 

(AF).

-- Search AV +: This automatic and expanded search method senses

the patient's natural heartbeats before delivering pacing

therapy, which may reduce unnecessary electrical impulses in

the ventricle and allow the heart to beat on its own as often

as possible. Recent clinical studies have suggested that

reducing this pacing stimulation may reduce the patient's risk

of developing heart failure and AF. A reduction in pacing also

may preserve the pacemaker battery and extend the life of the

device.

-- Quick Look(R) II interface: This new, innovative data display

allows clinicians to instantly access complete information

about the patient's heart rhythm and device activity on a

single, easy-to-understand screen, which simplifies the device

follow-up process and may allow physicians to spend more

quality time with the patient instead of performing lengthy

pacemaker tests. In addition, new trend monitoring

capabilities may reduce the amount of time needed to gather

key information and shorten patient office visits.

"The EnPulse pacemaker with ACM is the most significant advancement in years in the treatment of people with a slow heart rhythm. The device will provide both physicians and patients with a new level of confidence that this condition can be well-managed with minimal interruption to daily living," said Steve Mahle, president, Medtronic Cardiac Rhythm Management. "In addition, the ability for these patients to be managed from home with the Medtronic CareLink Network is another tremendous opportunity to improve the lives of people with heart disease."

Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com.

Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 25, 2003. Actual results may differ materially from anticipated results.