Healthcare Professionals

RestoreSensor SureScan MRI Neurostimulator

Spinal Cord Stimulation

Overview

The RestoreSensor SureScan MRI neurostimulator automatically adjusts stimulation based on the patient's needs and preferences in different body positions. AdaptiveStim™ automatically recognizes and remembers the correlation between a change in body position and the patient's programmed settings. In addition, RestoreSensor 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

ADAPTIVE STIMULATION TECHNOLOGY

AdaptiveStim Technology automatically adjusts all dosing parameters to deliver the right dose to the right location, as the pain target shifts with position. No other system can do this.

  • Provides a wide range of dosing options—LD and HD
  • Follows your patient's pain target
  • Maintains the optimal targeted energy dose within the therapeutic range
  • Allows for your patient's optimal pain relief and preferred sensation

Only AdaptiveStim Technology provides personalized pain management through a variety of low density (LD) and high density (HD) programming options. It automatically adjusts amplitude, pulse width and electrode configurations to maintain optimal therapy energy — at any density.

AdaptiveStim Technology delivers better pain relief: 88.7% of patients reported better pain relief vs. conventional stimulation:1,2

  • Automatically adapts to a patient's changing postural therapy needs
  • Maintains optimal therapy around the clock

Using three-axis accelerometer technology similar to what is used in smartphones and gaming devices, AdaptiveStim Technology:

  • Listens and senses when the patient changes position
  • Learns from previous experience and remembers the patient's last comfortable setting while upright (standing or sitting), lying down, or active in an upright position (e.g., jogging)
  • Responds by automatically adjusting stimulation to the patient's optimal settings in each position

OBJECTIVE ACTIVITY DATA

For the first time ever, clinicians can access objective activity data to assess, evaluate, and optimize a patient's neurostimulation experience. A function of AdaptiveStim Technology called AdaptiveStim Diary:

  • Provides objective data to augment the patient's subjective feedback for more one-to-one personalized medicine
  • Facilitates a more meaningful dialogue about patient activity level for therapy optimization
  • Provides the objective activity data to help patients set and track goals

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-lasting3 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 (RestoreSensor SureScan MRI) or model number (97714). You may also call 800-961-9055 for a copy of a manual.


MODEL SPECIFICATIONS

Model 97714
Battery Type Rechargeable
Weight 45g (1.6oz)
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.

RestoreSensor Clinical Study compared AdaptiveStim to Medtronic conventional stimulation; 88.7% is based on analysis of one of two questions that comprised the primary endpoint of improved convenience and/or better pain relief. Percentage based on respondents who completed the pain relief question. 


1

Medtronic advanced pain therapy using neurostimulation for chronic pain. Clinical Summary, 2014. M221494A009 REV. A

2

Schultz D, Webster L, Kosek P, Dar U, Tan Y, Sun M. Sensor-driven position-adaptive spinal cord stimulation for chronic pain. Pain Physician. 2012;15(1):1-12.

3

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.