Boston Scientific Spinal Cord Stimulation System - P030017/S275
This is a brief overview of information related to FDA's approval to market this product for new indications. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
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PMA Applicant: Boston Scientific Neuromodulation Corporation
Address: 24242 Rye Canyon Loop, Valencia, CA 91355
Approval Date: August 11, 2017
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030017S275a.pdf
What is it? The Boston Scientific Spinal Cord Stimulation (SCS) System is an implanted spinal cord stimulation system that was previously indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including one-sided (unilateral) or two-sided (bilateral) pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. The expanded indications include unilateral and bilateral pain associated with Complex Regional Pain Syndrome (CRPS) Type I and II. Additional associated conditions may be: radicular pain syndrome, radiculopathies resulting in pain secondary to failed back surgery syndrome or herniated disc, epidural fibrosis, degenerative disc disease, arachnoiditis, and multiple back surgeries. The two main components include:
- a stimulator device (signal generator) implanted under the skin that sends electrical signals to the spinal cord through an insulated lead wire, and
- a hand-held remote control that allows the patient to control the implanted stimulator device in order to achieve the best pain control.
How does it work? A health care provider implants the signal generator through a small incision in the patient's back. The health care provider then programs the signal generator to produce electrical signals that stimulate the spinal cord and block pain signals traveling to the patient's brain.
When is it used? The SCS system is used as an aid in the management of chronic intractable pain of the trunk and/or limbs. This includes pain on one or both sides of the trunk associated with failed back surgery syndrome, low back pain, and some kinds of leg pain. The system also helps in the management of pain conditions such as complex regional pain syndrome (CRPS), radicular pain syndrome, herniated disc, epidural fibrosis, degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions), arachnoiditis, and multiple back surgeries.
What will it accomplish? The SCS system may help to treat chronic intractable pain in the trunk and/or limbs for a variety of conditions. A review of 22 clinical study publications demonstrated an improvement in pain ranging from 29.2%-100% for CRPS patients, and 37-77% for those with back and leg pain due to surgery-associated conditions and etiologies across the studies.
When should it not be used? The SCS system should not be used in patients who are not healthy enough to undergo surgery, are unable to operate the SCS System, have not received effective pain relief during trial stimulation, or are pregnant.
Additional information (including warnings, precautions and adverse events): Summary of Safety and Effectiveness Data and labeling are available online.