Devices

FDA-approved Boston Scientific spinal cord stimulation family (Spectra WaveWriter, WaveWriter Alpha, Alpha Prime), with the SOLIS trial for patients without prior back surgery. Lead contact counts and IPG dimensions are not in the FDA summary read.

Catalog specification sheet - Peripheral nerve

Boston Scientific WaveWriter spinal cord stimulation

Primary source →

Record ID
BTSD-FDA-0022
Reviewed
2026-10-08
Interface
scs
Evidence stage
human

Independent, source-linked catalog sheet. Not a manufacturer-issued datasheet, regulatory decision or instructions for clinical use. Human evidence does not establish approval. Source-specific restrictions, conflicts and missing specifications are retained below.

Boston Scientific WaveWriter spinal cord stimulation

The WaveWriter family is Boston Scientific’s FDA-approved SCS line. This sheet uses the FDA summary for supplement S363, which added patients without prior back surgery based on the SOLIS trial. Hardware dimensions and contact counts are Unreported.

Identity

FieldValue and source scope
DeviceBoston Scientific Spectra WaveWriter, WaveWriter Alpha and WaveWriter Alpha Prime SCS Systems: IPG, percutaneous and surgical leads, extensions, splitters, adaptors, anchors and external trial stimulator [1][2]
ManufacturerBoston Scientific Corporation, Marlborough, Massachusetts [1]
Interface classEpidural spinal cord stimulation leads with an implanted IPG [1]
OriginCommercial FDA-approved device; PMA P030017, original approval April 27, 2004 [1]
First demonstratedUnreported
First human implantUnreported
Species studiedHuman [1]
Regulatory statusP030017/S363: FDA record decision date 02/05/2024; the SSED text prints the notice date as February 5, 2023, which does not match the record, so both are listed. S357 added diabetic peripheral neuropathy on October 5, 2023 [1][2]
FunctionDelivers electrical stimulation to the dorsal column of the spinal cord for chronic intractable pain of the trunk and/or limbs [1]
Target tissueDorsal column of the spinal cord [1]

Geometry and architecture

FieldValue and source scope
Interface typePercutaneous leads (Linear, Linear ST, Linear 3-4, Linear 3-6, Infinion, Infinion CX, Avista MRI) and surgical leads (CoverEdge, CoverEdge X, Artisan) [1]
Array layoutUnreported
Electrode countUnreported
PitchUnreported
Electrode lengthsUnreported
Shank width and thicknessUnreported
Tip and exposed site geometryUnreported
Contact coatingUnreported
InsulationUnreported
Insertion methodUnreported
Anchoring and fixationUnreported

Electrode and channel physics

FieldValue and source scope
Exposed site areaUnreported
Electrode materialUnreported
Impedance (with measurement frequency)Unreported
Noise floor or SNRUnreported
Recording modalityUnreported
Sampling rateUnreported
Stimulation capabilityUnreported
Charge injection limitUnreported
Reference and groundUnreported

Tissue interface and bioresponse

FieldValue and source scope
Target tissueUnreported
Insertion trauma and BBB disruptionUnreported
Vascular disruption riskUnreported
Micromotion sensitivityUnreported
Gliosis and encapsulationUnreported
Neuron loss near sitesUnreported
Foreign-body response mitigationUnreported
Typical failure modesUnreported

System architecture

FieldValue and source scope
Onboard electronicsIPG generates programmable pulses; rechargeable or non-rechargeable battery models [1]
Data pathUnreported
Telemetry bandwidthUnreported
Sampling rateUnreported
PowerUnreported
Thermal managementUnreported
Packaging and hermeticityUnreported
MRI compatibilityUnreported
Surgical complexityUnreported
Output connectorsAdaptors connect other manufacturers’ leads (M8 for Medtronic leads, S8 for Abbott leads); lead extensions 25, 35 and 55 cm [1]

Performance envelope

FieldValue and source scope
Acute yieldUnreported
Chronic yieldUnreported
Stability over timeUnreported
LongevityUnreported
Revision and explant experienceUnreported
Adverse eventsUnreported
Notable demonstrationsUnreported

Clinical and preclinical evidence

FieldValue and source scope
Human subjectsSOLIS: 212 enrolled at the September 14, 2022 snapshot; 115 randomized (64 SCS, 51 conventional medical management); pre-specified cohort of 60 activated subjects; 23 US sites [1]
Preclinical cohortUnreported
Follow-up durationPrimary endpoint at 3 months after activation; study ongoing at the time of the SSED [1]
IndicationsChronic intractable pain of the trunk and/or limbs including failed back surgery syndrome, CRPS I and II, intractable low back and leg pain, diabetic peripheral neuropathy of the lower extremities, and chronic low back and leg pain without prior back surgery for the WaveWriter systems [1]
Trials and registriesSOLIS: prospective, multicenter, randomized controlled trial, SCS versus conventional medical management, 1:1 [1]
Primary outcomesAt 3 months post-activation: 87.5% responder rate (50% or greater pain relief with no opioid increase) for SCS versus 8.3% for conventional medical management, p < 0.0001 [1]
Key limitationsInterim analysis of 60 subjects; the SSED itself notes the uncontrolled design aspects. 116 adverse events reported, 25 serious, 6 study-related events from one patient with an epidural abscess [1]

Engineering tradeoffs

FieldValue and source scope
StrengthsUnreported
LimitationsUnreported
Scaling constraintsUnreported

Version boundary

S363 covers Spectra WaveWriter, WaveWriter Alpha and WaveWriter Alpha Prime. The SSED prints February 5, 2023 as the approval notice date while the FDA record shows a decision date of 02/05/2024.

References

  1. FDA summary of safety and effectiveness, P030017/S363.
  2. FDA PMA record, P030017/S363.