PRODUCT CATALOG

Chronic Pain Therapies | Dorsal Root Ganglion Therapy | Percutaneous Leads and Delivery Sheaths (DRG)

AxiumTM Neurostimulator System SlimTipTM Lead

Product Highlights

The AxiumTM Neurostimulator System SlimTip™ lead is engineered specifically for Dorsal Root Ganglion (DRG) stimulation.

  • Specifically shaped to lay across the DRG and designed for optimal stimulation delivery
  • 1.0 mm in diameter lead construction
  • 5.0 mm in spacing between contacts with 1.25 mm contacts (flexible design)
  • Front loading delivery system
Axium<sup>TM</sup> Neurostimulator System SlimTip<sup>TM</sup> Lead


Reorder Number Diameter Available Length (cm) Electrode Spacing (mm) Number of Electrodes
MN10350-50A 1.0 mm 50 cm 5.0 mm 4
MN10350-90A 1.0 mm 90 cm 5.0 mm 4
MN10450-50A 1.0 mm 50 cm 5.0 mm 4
MN10450-90A 1.0 mm 90 cm 5.0 mm 4

*Reference to "50A" and "90A" in the lead model numbers refers to 50 cm and 90 cm lead lengths.

Rx Only

 

Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

 

Indications for Use: The AxiumTM Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.**

 

*Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study.

 

**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively.

 

Contraindications: Patients contraindicated for the Axium Neurostimulator System are those who are unable to operate the system and are poor surgical risks. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to proceed to the INS procedure.

 

Potential Adverse Events: The implantation of a neurostimulation system involves risk. Implant Manual must be reviewed for detailed disclosure.

 

Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

 

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN.

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies.

©2018 St. Jude Medical, Inc. All rights reserved.

SJM-AXM-1115-0015

Last Updated: March 28, 2016