Healthcare Professionals

RestoreUltra SureScan MRI Neurostimulator

Spinal Cord Stimulation

Overview

The RestoreUltra SureScan MRI neurostimulator is a 16-electrode rechargeable neurostimulator that offers a flexible ambulatory recharge system. It delivers spinal cord stimulation through one or more leads for customization of therapy.

In addition, RestoreUltra SureScan MRI allows patients safe* access to MRI scans anywhere in the body.


INDICATIONS

A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbs — including unilateral or bilateral pain associated with the following conditions:

  • Failed Back Syndrome (FBS) or low back syndrome or failed back
  • Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk
  • Postlaminectomy pain
  • Multiple back operations
  • Unsuccessful disk surgery
  • Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions
  • Peripheral causalgia
  • Epidural fibrosis
  • Arachnoiditis or lumbar adhesive arachnoiditis
  • Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia

PRODUCT DETAILS

FEATURES

The RestoreUltra SureScan MRI neurostimulator has FDA-approved labeling for 1.5-Tesla MRI scans anywhere on the body. Along with RestoreSensor, RestoreUltra SureScan MRI is the smallest and thinnest (22cc) 16-electrode neurostimulator available from Medtronic.

RestoreUltra SureScan MRI is part of the first pain neurostimulation systems that allow patients safe* access to MRI scans anywhere on the body. SureScan MRI Systems provide long-lasting chronic pain treatment with the confidence of knowing that patients can also get optimal diagnostic treatment whenever the need arises.

RestoreUltra SureScan MRI is a rechargeable device with a 9-year device life.

MRI ELIGIBILITY

Medtronic offers the first pain neurostimulation system with SureScan MRI Technology that is FDA-approved and engineered for patients to safely undergo an MRI scan anywhere in the body.*

SureScan MRI Systems provide long-lasting1 chronic pain treatment with the confidence of knowing that patients can also get optimal diagnostic treatment whenever the need arises.

When an MRI is needed for a patient with an implanted pain stimulation system, programmer software simplifies the identification of implanted system components and MRI-scan eligibility.

COMPATIBLE PRODUCTS

  • 1x8 Vectris SureScan MRI percutaneous leads
  • 16-electrode Specify SureScan MRI surgical leads
  • N’Vision™ clinician programmer model 8840
  • MyStim™ Patient Programmer Model 97740
  • Injex Anchoring System Models 97791 and 97792

MANUALS AND TECHNICAL GUIDES

Access prescriber, implant, MRI, and other manuals on the Medtronic Manual Library. Search by the product name (RestoreUltra SureScan MRI) or model number (97712). You may also call 800-961-9055 for a copy of a manual.


MODEL SPECIFICATIONS

Model 97712
Battery Type Rechargeable
Weight 45 g (1.6 oz)
Height 54 mm (2.1 in)
Length 54 mm (2.1 in)

*

MR Safety Triangle Under specific conditions. Requires SureScan™ MRI implantable neurostimulator and leads. Refer to product labeling for full list of conditions.


1

Kumar K, Taylor RS, Jacques L, et al. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month followup of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008;63(4):762-770.