Healthcare Industry News:  neurostimulator 

Devices Neurology Pain Management FDA

 News Release - February 6, 2008

Medtronic Receives U.S. FDA Approval for New Neurostimulator with Innovative Patient Programmer

Smallest and Thinnest 16-Electrode Neurostimulation System Empowers Patients to Maximize Pain Relief

MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ), today announced it has received U.S. Food and Drug Administration (FDA) approval to market the RestoreULTRA™ neurostimulation system for the treatment of chronic intractable pain of the trunk and/or limbs (chronic back and leg pain). This rechargeable neurostimulator, the most advanced device in the market-leading Medtronic family of RESTORE® devices, is the smallest and thinnest 16-electrode rechargeable neurostimulator available. The unique patient programmer used with the RestoreULTRA system gives patients more control over their therapy than ever before. In addition, the RestoreULTRA neurostimulator allows patients who use medium stimulation settings to go at least two weeks before needing to recharge.

For the first time with any neurostimulator, the patient programmer includes an innovative new feature called TARGETmyStim™. This feature allows patients to make appropriate and immediate adjustments in their stimulation in order to best address normal fluctuations in pain, including changing pain patterns. By using the remote control programmer, patients can fine-tune their stimulation to specific sites up and down the spinal cord and increase/decrease the intensity of the electrical impulses. These adjustments allow the patient to customize their pain therapy in a way that was previously only possible with a physician programmer during an office visit.

“The RestoreULTRA system is one of the most significant advances in neurostimulation therapy since the introduction of rechargeable devices,” said George Mandybur, M.D., associate professor and neurosurgeon, Mayfield Clinic and Spine Institute in Cincinnati. “The small and thin size provides improved flexibility for implant location and patient comfort, and the TARGETmyStim feature will give patients greater control over their own pain management – something many who suffer from chronic pain feel they had lost.”

“With the approval of the RestoreULTRA system, we are proud to offer a device that can empower chronic pain patients to take control in maximizing the benefits of their therapy,” said Richard E. Kuntz, M.D., senior vice president of Medtronic, Inc., and president of the company’s Neuromodulation business, which includes Global Pain Management. “Considering the emerging scientific evidence about neurostimulation benefits just published in the journal, PAIN, we expect that the innovative features of the RestoreULTRA system will add an important therapy option for patients suffering from chronic pain.”

Results from the largest multi-center randomized controlled trial of neurostimulation therapy were recently published online by the international medical journal, PAIN. This Medtronic-sponsored study, known as PROCESS (for PROspective randomized Controlled trial of the Effectiveness of Spinal cord Stimulation), compared neurostimulation therapy plus conventional medical management to conventional medical management alone in the treatment of chronic neuropathic back and leg pain for six months.

The RestoreULTRA neurostimulation system is indicated to manage chronic, intractable pain in the trunk and/or limbs including unilateral or bilateral pain. Implanting a neurostimulator system has risks similar to spinal procedures, including spinal fluid leaks, headaches, swelling, bruising, bleeding, infection or paralysis. The RestoreULTRA neurostimulation system is currently available in Europe and will be available in the United States by the end of February.

Neurostimulation, developed by Medtronic in partnership with physicians, uses an implantable medical device to deliver electrical pulses to the epidural space in order to block pain signals traveling through the nervous system from reaching the brain. The RestoreULTRA neurostimulator is smaller than a pocket watch and is typically placed under the skin of the abdomen and connected to flexible wires called leads that deliver the electrical pulses. In contrast to surgical treatments for chronic pain, neurostimulation therapy is adjustable and reversible.

Information for clinicians about the RestoreULTRA system is available at www.RestoreULTRA.com. Patients in the United States can obtain information on Medtronic neurostimulation pain therapies at www.TameThePain.com or by calling 1-888-430-PAIN (7426).

About the Neuromodulation Business at Medtronic

Medtronic developed and leads the field of neuromodulation, the targeted and regulated delivery of electrical pulses and pharmaceuticals to specific sites in the nervous system. The company’s Neuromodulation business offers innovative therapies for chronic pain, movement disorders, spasticity, overactive bladder, benign prostatic hyperplasia and gastroparesis.

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.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results.



Source: Medtronic

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