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

The difference here is the ability of the patient to make the adjustments versus the physician in the past being the only one to adjust...implant device with remote and perhaps good news for those with chronic back pain. BD

MINNEAPOLIS – Feb. 6, 2008 – 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.