Neurostimulator from Medtronic Approved
The RestoreULTRA neurostimulation system, designed and manufactured by Medtronic, received approval from the Food and Drug Administration. This new product is the most advanced product available from Medtronic for neurostimulation in the RESTORE product line. News of the approval was shared in a news release published by Medtronic. The device is already available in Europe and should be available in the U.S. later this month.
The new system is indicated for use in patients with chronic intractable pain in the limbs or trunk (chronic leg and back pain) that is either unilateral or bilateral in nature. The RestoreULTRA is a 16-electrode rechargeable neurostimulator; the thinnest and smallest neurostimulation device available on the market. One benefit of the smaller profile is an increased array of locations where the device can be implanted, as well as improved comfort for patients.
The system includes a programmer for patients to arrange delivery of neurostimulation therapy. Included in the Restore ULTRA is a new feature, TARGETmyStim. This tool supports immediate adjustments to stimulation delivered to address normal fluctuations in pain experienced by patients throughout the day.
Using the remote control for programming, patients optimize treatment to distinct locations along the spine. Patients can also adjust the intensity of the electrical impulses. This sort of therapy modification was previously only completed by clinicians while patients were being seen in the office.
Devices are most commonly placed under abdominal skin. Flexible leads attach from the device to the epidural spaces along the spine where electrical pulses are delivered. This approach to treating chronic pain is both reversible and can be adjusted over time, which is a distinct benefit compared to other approaches to treat chronic pain. Surgical therapies, for example, are generally not reversible.
February 11, 2008 Related topics: Product Approval & Certification, Anesthesiology