PRODUCT CATALOG

Chronic Pain Therapies | Dorsal Root Ganglion Therapy | Implantable Pulse Generators (IPGs) (DRG)

AxiumTM Neurostimulator System

INM

Product Highlights

The Implantable Neurostimulator (INS) is specifically designed to be a fully-implantable stimulator that delivers precisely programmed electrical pulses to the Dorsal Root Ganglion (DRG) via stimulation leads. The INS is a 16-channel stimulator (four channels on each stimulation lead accommodating up to four leads) and communicates wirelessly to the programmers.

Axium<sup>TM </sup>Neurostimulator System


Ordering Information

Reorder Number Dimensions (H x W x T, cm) Volume (cc) Power Supply
MN10200 6.5 cm x 4.8 cm x 1.1 cm 32 cm3 CFx, lithium - carbon monofluoride

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-1115-0019

Last Updated: March 28, 2016