BACKGROUNDER

Medtronic CareLinkÒ Network

Overview

The Medtronic CareLinkÒ Network is the leading Internet-based system to help physicians and patients better manage chronic cardiovascular disease treated by implantable device therapy, such as pacemakers and implantable cardioverter-defibrillators (ICDs). The service provides an efficient, safe and convenient way for specialty physicians to remotely monitor the condition of their patients. Medtronic launched the CareLink Network in the United States in 2002 and it was made available in Europe in 2007.

Physician Benefits

Remote monitoring of devices allows clinicians to quickly and thoroughly review the status of a patient’s heart condition and any changes that may have occurred since the last in-person appointment or remote transmission. The CareLink Network also helps facilitate a timely exchange of device information between various physicians involved in treating heart failure patients, including the electrophysiologists who implant and monitor CRT devices and cardiologists who follow the patient’s heart failure condition.

Patient Benefits

Because patients can transmit critical data from their heart device using a phone line from home, work or while on vacation, they enjoy freedom from time-consuming travel to the physician’s office for device monitoring. The service also provides peace of mind for the patient and family members, knowing that if a health concern arises between scheduled in-person appointments or remote data transmissions, patients have the option to transmit data for special clinician review if directed by their physician.

Who Can Use It?

More than 500,000 patients affiliated with more than 4,000 cardiology clinics in 30 countries currently are using the service. Those with a wide variety of Medtronic implantable cardiac devices and who are followed by a physician that has chosen to offer the Medtronic CareLink Network can use the service today. In the future, the system will be used with additional device-based therapies to achieve disease management benefits.

The following Medtronic ICDs, CRT-Ds, Pacemakers and ICMs can be used with the CareLink Network:

Protecta™ XT CRT-D / Virtuoso® ICDs / Concerto® CRT-Ds / Sensia® pacemakers
Protecta™ XT DR and VR / EnTrust® ICDs / InSync Sentry® CRT-Ds / EnPulseÒ pacemakers
Protecta™ CRT-D / Intrinsic® DR ICDs / InSync Maximo® CRT-Ds / KappaÒ 900 pacemakers
Protecta™ DR and VR / MarquisÒ DR and VR ICDs / InSync MarquisÔ CRT-Ds / KappaÒ 800 pacemakers
Vision 3D™:
Secura™ ICDs / Maximo® DR and VR ICDs / InSync II MarquisÔ
CRT-Ds / KappaÒ 700 pacemakers
Vision 3D™:
Maximo® II ICDs / GEMÒ III DR and VR ICDs / InSync ICDÒ CRT / KappaÒ 600 pacemakers
Vision 3D™:
Consulta™ CRT-Ds / GEMÒ II DR and VR ICDs / Adapta® pacemakers / Reveal® DX ICM
Vision 3D™:
Maximo® II CRT-Ds / GEMÒ and GEMÒ DR ICDs / Versa® pacemakers / Reveal XT™ ICM

How the Medtronic CareLink Network Works

The CareLink Network provides the most flexible alert system in the industry that offers customizable and color-coded alert notifications for devices with Conexus Wireless Telemetry. Through this network, patient data are transmitted from their implantable device using a portable monitor that is connected to a standard telephone line. Within minutes, the patient’s physician and nurses can view the data on a secure Internet Web site. Available information includes arrhythmia episode reports and stored electrograms along with device integrity information, which is comparable to the information provided during an in-clinic device follow-up visit, and provides the physician with a view of how the device and patient’s heart are operating.

The CareLink Network also serves as the communications platform for Medtronic’s distance wireless telemetry, Conexus® Wireless Telemetry with SmartRadio™, which allows for remote and automatic transmission of device data to physicians at preset dates and times, or if the system detects a notable change in the patient’s condition. Conexus Wireless Telemetry currently is available with the Medtronic Vision 3D™ portfolio of cardiac resynchronization therapy-defibrillators (CRT-Ds) and ICDs, and the Concerto® CRT-D and Virtuoso® ICDs.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

contactS:

Wendy Dougherty

(763) 526-2853

Brief Statement

Medtronic ICDs and CRT-ICDs

Medtronic Implantable Cardioverter Defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Medtronic Cardiac Resynchronization Therapy (CRT) ICDs are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias and for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration.

Contraindications

Medtronic ICDs and CRT-ICDs are contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, patients with incessant VT or VF, or patients who have a unipolar pacemaker. Medtronic ICDs are also contraindicated for patients whose primary disorder is bradyarrhythmia.

Warnings and Precautions

Changes in a patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. Additionally, for CRT-ICDs, certain programming and device operations may not provide cardiac resynchronization.

Potential Complications

Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate tachyarrhythmia episodes, acceleration of ventricular tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis.

See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com.

# # #

2