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Medtronic Receives FDA Approval For Non-Rechargeable Neurostimulator

25 Mar 2006

RestorePRIME™ Neurostimulation System offers unrivaled convenience, control and coverage for people with chronic pain

MINNEAPOLIS, IN, USA | Mar 24, 2006 | Medtronic, Inc. (NYSE: MDT), today announced U.S. Food and Drug Administration (FDA)

approval of the RestorePRIME™ Neurostimulation System for the treatment of chronic pain, which affects an estimated 75 million Americans.

Indicated for patients with intractable chronic pain of the trunk or limbs, neurostimulation works by blocking pain signals traveling up the spinal cord – the pain pathway – to the brain. The RestorePRIME System represents a new treatment option for neurostimulation beneficiaries with low to moderate energy requirements.

The introduction of the RestorePRIME System follows the recent launch of the Medtronic Restore® neurostimulator, the most powerful and longest-lasting rechargeable device of its kind on the market. The latest in a family of neurostimulation products from Medtronic, the RestorePRIME neurostimulator offers the same coverage, customization and advanced therapy options of the earlier device, without the need to recharge. It is the first and only 16-electrode, non-rechargeable neurostimulator.

Medtronic, the pioneer of neurostimulation technology, will initiate a targeted launch of the RestorePRIME System in March and April, followed by full market availability in May. The new system offers the broadest number of programming options and the largest stimulation coverage area of any non-rechargeable neurostimulator available today in a small device.

The RestorePRIME neurostimulator is a non-rechargeable device indicated to manage bilateral and complex pain in the trunk and/or multiple limbs that is associated with failed back surgery syndrome, post-laminectomy pain, unsuccessful disc surgery or degenerative disc disease, among others. It is designed specifically for patients with low to moderate energy requirements who need a broader range of neurostimulation coverage but prefer the improved convenience of a non-rechargeable system.

About the size of a stopwatch, the device is typically implanted under the skin of the abdomen and connected to two leads – thin wires with electrodes at the tips. Up to 16 electrodes deliver electrical pulses to the spine. Based on individual patient need, doctors can customize the positioning of the electrodes to deliver stimulation directly to the target area of the spine – and in doing so, block pain signals from reaching the brain. Additionally, to cover varying levels of pain, they can choose for their patients up to 32 program options, the broadest range of any non-rechargeable device on the market. Battery life is similar to that of other non-rechargeable devices, such as the Synergy® neurostimulator from Medtronic.

“The RestorePRIME System is a significant advancement in the field of neurostimulation,” said Dr. Joshua Prager, pain specialist and director of the Center for Rehabilitation of Pain Syndromes (CRPS) at UCLA Medical Plaza, Departments of Internal Medicine and Anesthesiology, David Geffen School of Medicine at UCLA. “It has robust programming capabilities and 16-electrode coverage with multiple simultaneous configurations. These features allow physicians to customize the treatment to treat their patients’ chronic pain more accurately, potentially reducing the number of return visits and improving pain relief.”

Patients can obtain information on Medtronic neurostimulation therapies at www.TameThePain.com or by calling 1-888-430-PAIN (7426). Information for clinicians about the new device is available at www.MedtronicRestorePrime.com.

“Chronic pain, especially in this country, is seemingly growing without satisfactory therapeutic solutions to combat its impact on patients,” said Dr. Richard Kuntz, senior vice president of Medtronic and president of Medtronic’s Neurological division. “As a physician, I fully support intense therapeutic research and development for this unmet need of those who suffer from chronic pain, including further investigation and dissemination of Medtronic’s pioneering chronic pain management solutions that apply a variety of novel implantable neuromodulation treatments.”

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.

SOURCE: Medtronic, Inc.

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