Spectra WaveWriter, WaveWriter Alpha, WaveWriter Alpha Prime Spinal Cord Stimulation Systems - P030017/S363
This is a brief overview of information related to the FDA’s approval to market this product. 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 the FDA’s approval.
Product Name: Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System
PMA Applicant: Boston Scientific Corp.
Address: 25155 Rye Canyon Loop, Valencia, CA 91355 USA
Approval Date: February 5, 2024
Approval Letter: Approval Order
What is it?
Boston Scientific’s WaveWriter Spinal Cord Stimulation (SCS) Systems are implanted (placed into the body) to help reduce pain that is chronic (long-term) and intractable (difficult to manage) in the legs, arms, or trunk.
The main parts of these SCS systems are an implanted pulse (signal) generator that is connected to one or two implanted leads, a remote control, and a clinician programmer (a program on a tablet that provides a health care provider information).
This supplement expands the Indications for Use to include treatment of low back and leg pain that is difficult to manage without prior back surgery.
The implanted pulse generator (IPG) receives radio signals from the controller used by the patient. The signals tell the IPG when to deliver the right level of stimulation (activation) to the spinal cord.
Boston Scientific’s WaveWriter SCS Systems are used to help manage chronic, intractable pain in the trunk, arms, or legs, including one-sided or two-sided pain associated with the following:
- Failed back surgery syndrome (pain that continues to happen after spinal surgery).
- Complex regional pain syndrome (CRPS), types I and II.
- Intractable low back and leg pain with or without prior back surgery.
- Radicular (nerve root) pain syndrome.
- Radiculopathies (irritations or injuries to a spinal nerve root) resulting in pain secondary to failed back syndrome or herniated disc.
- Epidural fibrosis (extra scar tissue near the root of the nerve).
- Degenerative disc disease (wear on the discs in the spine causing pain that is not responding to conservative and surgical treatments).
- Arachnoiditis (inflammation or swelling of a thin lining of the brain and spinal cord).
- Multiple back surgeries.
- Diabetic peripheral neuropathy of the lower parts of the body.
Data from Boston Scientific’s SOLIS study supports the effectiveness of Boston Scientific’s WaveWriter SCS Systems’ when treating people with chronic, difficult to manage low back and leg pain without prior back surgery.
The study reports that about 56 patients who received SCS therapy experienced a 50% or greater reduction in average overall (low back, leg, or both) pain intensity, for one year. Information from the SOLIS study also showed that the chance of developing a health problem stayed acceptable for this group.
Boston Scientific’s SCS Systems should not be used in patients who:
- Are not able to control the SCS system.
- Have not received effective pain relief during trial stimulation.
- Are not healthy enough to have surgery.
- Are pregnant.
- Summary of Safety and Effectiveness Data (SSED)
- Labeling - Patient Indications for Use
- Labeling Part 2 - Physician Directions for Use
- PMA Database entry