Medtronic Inc., has received FDA approval for their RestorePRIME™ Neurostimulation system.
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 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(R) neurostimulator from Medtronic.
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
It’s interesting to see the specific URLs for patient and physician information. Following tamethepain.com redirects to a Medtronic internal site that’s designed to look a lot like its own entity. The site states “Tame the Pain is an advocacy and awareness campaign designed to improve chronic pain management by connecting people who have chronic pain with pain specialists.” In the world of marketing, this is direct-to-consumer at it’s finest – setting up a means of increasing patient awareness of treatment options and facilitating their treatment through “on board” physicians. By the way, “Tame the Pain” is copyrighted.