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Spinal cord stimulation · Peripheral nerve stimulation

Boston Scientific Neuromodulation

Boston Scientific's WaveWriter Alpha platform is built around the idea that no single waveform suits every patient — it can deliver several stimulation types, including its FAST sub-perception therapy, alone or in combination. The company also now offers the Nalu battery-free system as its peripheral nerve stimulation option.

At a glance

Signature waveform
FAST sub-perception therapy
Contacts
16 or 32, percutaneous or paddle
Power options
Rechargeable and primary cell
Also offers
Nalu battery-free PNS
SCS
PNS
Multiple waveforms in one device, including fast-acting sub-perception therapy.

The Signature Technology

FAST therapy and Combination therapy

FAST — Fast-Acting Sub-perception Therapy — is a paresthesia-free waveform intended to produce relief quickly rather than over a long titration period, and is described by the manufacturer as working through surround inhibition, a mechanism distinct from earlier sub-perception approaches. Combination therapy is the platform's other distinguishing capability: the ability to layer more than one waveform at the same time, so a patient with both back and leg pain can be programmed differently for each.

How It Works

From lead placement to therapy delivery

  1. 01

    Percutaneous leads or a surgical paddle lead are placed in the epidural space and connected to an implantable pulse generator with either 16 or 32 contacts.

  2. 02

    Because the generator supports several waveforms, programming is not a single fixed setting. The physician can trial paresthesia-based stimulation, sub-perception stimulation, FAST, or a combination, and adjust over time.

  3. 03

    Patients manage their therapy through the mySCS app on a therapy controller, which allows within-limits adjustment and communication with the care team.

The Platforms

3 systems in the family

Each system in this family is built on the same underlying technology, but they differ in power source, size and intended use.

  • WaveWriter Alpha

    SCS — rechargeable and primary cell

    The current flagship SCS portfolio, offered in both rechargeable and recharge-free (primary cell) generators, with 16- and 32-contact options.

    • Full-body MRI conditional portfolio
    • FAST and Combination therapy capable
    • mySCS patient app for therapy control
  • Spectra WaveWriter

    SCS — rechargeable

    The earlier generation of the combination-therapy platform, still in service in many implanted patients.

    • Combination therapy capable
    • 32 contacts
    • Rechargeable generator
  • Nalu System

    PNS — battery-free micro-IPG

    Boston Scientific's peripheral nerve stimulation offering, using Nalu's miniature battery-free implanted pulse generator powered by an external Therapy Disc.

    • No implanted battery
    • Powered by a small wearable disc
    • Peripheral nerve targets

The Evidence

What has been published

Each study is given with its design, who was actually in it, what it found and where it falls short — then a link to the paper itself, so you can check any of it. Most device trials are manufacturer-funded; that is normal in this field and it is labelled here rather than glossed over.

  • FAST outcome studies

    Multi-year follow-up has been published for FAST in both European and U.S. cohorts, with reported durability of pain reduction extending beyond three years in the longer-term analyses.

  • Expanded indications

    In February 2024 the WaveWriter systems received an expanded FDA indication covering non-surgical refractory back pain — patients with chronic back pain who have not had, and are not candidates for, spine surgery.

  • Diabetic peripheral neuropathy

    The platform carries an indication for painful diabetic peripheral neuropathy. Importantly, the labeling notes that only paresthesia-based stimulation has been evaluated for effectiveness in that population.

These are the studies specific to Boston Scientific. For the trials that shaped the whole field — and for how to read an industry-sponsored study fairly — see the clinical evidence library.

The Trade-offs

What to weigh before choosing this platform

No system is the right answer for every patient. These are considerations to discuss with the clinician who knows your history.

  • Waveform flexibility is only an advantage if the programming is actually revisited — it depends on an engaged physician and follow-up plan.

  • The DPN indication carries a specific labeling caveat about which stimulation type has been studied in that population.

  • Rechargeable versus primary cell is a genuine trade-off and should be discussed in the context of your expected settings and lifestyle.

Regulatory status

WaveWriter Alpha is FDA approved for chronic intractable pain of the trunk and/or limbs, with an expanded indication for non-surgical refractory back pain granted in February 2024.

Indications, contraindications, warnings and MRI conditions are defined by the current labeling. Review the manufacturer's Instructions for Use at bostonscientific.com and discuss them with your physician.

Wondering whether this therapy fits your situation?

Explore how candidacy is assessed, then discuss your pain pattern, imaging and prior treatments with a clinician. Device selection comes later.