Implantable neurostimulator Spectra WaveWriter™

for spinal cord stimulationMRI compatible

Overview
The Spectra WaveWriter™ SCS System personalizes pain management by enabling Combination Therapy and waveform automation. It collects real-time patient therapy ratings and generates optimization reports to support clinicians in tailoring therapy over time.

How it works
Real-time patient therapy ratings and corresponding optimization reports allow clinicians to compare therapies and adjust programming as a patient’s pain pattern evolves. Combination Therapy enables simultaneous layering of waveforms to target multiple neural substrates.

Key clinical insights

• Different mechanisms may underlie different stimulation therapies.
• Some patients respond only to a single therapy modality.
• Providing multiple therapy options can improve outcomes by allowing selection of the most effective approach for each patient.

Product features

• Paresthesia-based and sub-perception stimulation modes
• 32 contacts and 4 ports
• Leads covering up to 3 vertebral levels
• Combination Therapy enabling simultaneous waveform layering
• Contour™ Therapy for broad paresthesia-free coverage across multiple neural targets

Indications, contraindications, warnings
The Boston Scientific Spinal Cord Stimulator Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome; Complex Regional Pain Syndrome (CRPS) Types I and II; intractable low back and leg pain; Diabetic Peripheral Neuropathy (DPN) of the lower extremities; radicular pain syndromes; radiculopathies secondary to failed back syndrome or herniated disc; epidural fibrosis; degenerative disc disease; arachnoiditis; and multiple back surgeries. The Spectra WaveWriter™, WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems are also indicated for chronic intractable unilateral or bilateral low back and leg pain without prior back surgery.

Contraindications: The SCS Systems are contraindicated for patients who cannot operate the system, who had an unsuccessful trial stimulation (no effective pain relief), who are poor surgical candidates, or who are pregnant.

Warnings/precautions: Full directions for use and information on potential adverse effects, warnings and precautions are provided with the SCS System. Specific caution: only paresthesia-based stimulation has been evaluated for effectiveness in the diabetic peripheral neuropathy population. Sub-perception stimulation has demonstrated safety and effectiveness in patients with prior successful paresthesia-inducing stimulation for at least six months.

Ordering information
Product Name | Model Number | UPN
Spectra WaveWriter Implantable Pulse Generator (IPG) Kit | SC-1160 | M365SC11600
Spectra WaveWriter IPG and Charger Kit | SC-1060B | M365SC1060B0
FreeLink™ Remote Control Kit | SC-5562-1 | M365SC556210
Spectra WaveWriter Trial Kit | SC-6500-62 | M365SC6500620

References / Clinical data highlights
Randomized controlled trials and real-world studies, including Level 1 RCTs and multi-year outcome data, support clinical outcomes with Combination Therapy and advanced waveform approaches in SCS.

Technical specifications

• Supported therapies: paresthesia-based and sub-perception stimulation
• Contacts / ports: 32 contacts and 4 ports
• Lead coverage: up to 3 vertebral levels
• Combination Therapy: simultaneous waveform layering capability
• Contour™ Therapy: broad paresthesia-free coverage across multiple neural targets
• MR information: System is MR-Conditional under specific conditions when used with ImageReady™ MRI Technology (see MRI guidelines)
• Relevant model numbers/kits: SC-1160 (M365SC11600), SC-1060B (M365SC1060B0), SC-5562-1 (M365SC556210), SC-6500-62 (M365SC6500620)
• Intended use: aid in management of chronic intractable trunk and/or limb pain as specified in indications