WaveWriter Alpha SCS by Boston Scientific: status and timeline

WaveWriter Alpha SCS

Give people with chronic pain that drugs and surgery haven't fixed a non-opioid option, and widen who qualifies, from failed back surgery to diabetic neuropathy and unoperated back pain.

ScalingStage 5 of 5

On the US market since 2021; approved for diabetic nerve pain (2023) and non-surgical back pain (2024).

Updated 6 Feb 2024Checked 11 Oct0 updates this week

Milestones

No announced next step

European launchSep 2020Complete.
FDA approval of four-model WaveWriter Alpha family2 Dec 2020Complete.
US limited market releaseJan 2021Complete.
FDA approves use for painful diabetic neuropathy11 Oct 2023Complete.
FDA approves use for non-surgical back pain (SOLIS trial)6 Feb 2024Complete.

Most important updates

Current obstacles

Relief fades for some patientsA share of patients lose benefit over time; multiple waveforms and reprogramming are meant to keep relief going.
Crowded marketAbbott, Medtronic and Globus Medical (which bought Nevro in 2025) all sell competing spinal cord stimulators, so doctors can choose among several systems.

Physics limits

Current spreads through tissueElectricity flows through fluid and tissue, not just the target nerves. Raising current to reach deep fibres also spreads it to unwanted ones, limiting how precisely pain can be targeted.
Pain is not one signalChronic pain involves the brain as well as the spinal cord, so blocking spinal signals helps many people but cannot erase pain that the brain itself sustains.
Batteries cap the implantEnergy per volume is fixed by battery chemistry, so a smaller implant means more frequent recharging or an earlier replacement surgery.

How it works

4 parts

Leads

Electrodes over the spinal cord

Thin leads with 16 or 32 contacts sit in the space just outside the spinal cord, wired to a pulse generator implanted under the skin.

Signals

Pulses that crowd out pain

Mild electrical pulses change how spinal nerve cells relay pain, so fewer pain signals reach the brain. Some settings tingle; others can't be felt.

Waveforms

Several patterns at once

The device can run different pulse patterns, fast or slow, steady or in bursts, together, since patients respond differently and needs drift over time.

Power

Recharge or replace

Rechargeable models are small but need regular wireless charging; non-rechargeable ones are larger and are swapped out surgically when the battery runs down.

Spec sheet

Spec	WaveWriter Alpha SCS
Implant models	4 (2 rechargeable, 2 not)^R (reported)
Electrode contacts	16 or 32^R (reported)
Implant volume	20.1–36.6 cc^R (reported)
Pulse rate range	2–1,200 Hz^R (reported)
Max current	25.5 mA^R (reported)
SOLIS: ≥50% pain relief at 1 year	84% of patients^R (reported)

^R reported by the company

Update log

2 updates

Tue 6 Feb 2024

Major: FDA approves WaveWriter stimulators for back pain in people who never had back surgeryPressRegulatory

Wed 11 Oct 2023

Major: FDA expands WaveWriter Alpha spinal cord stimulators to painful diabetic neuropathyPressRegulatory

About Boston Scientific

The team behind WaveWriter Alpha SCS

Boston Scientific

Neuromodulation, DBS, cardiovascular devices, medical devices

Boston Scientific manufactures DBS systems including Vercise Genus with 16-contact directional leads. Entered neuromodulation via Advanced Bionics (2004) and Intelect Medical (2011).

Boston Scientific acquired Advanced Bionics 2004 and Intelect Medical 2011 to enter neuromodulation.
Vercise Genus launched Jan 2021, features 16-contact directional leads with >200% directional span.
Second-largest neuromodulation player; competes with Medtronic and Abbott in DBS and SCS.

bostonscientific.com (opens bostonscientific.com)Company profile →

Founded: 197947 yrs
Headquarters: United States
Status: Public
Valuation: public
Staff: ~59,000Jan 2025
Works in: NeurotechStimulation therapies
Coverage: 4 programs · 10 updateslatest 29 Jul 2026checked 10 Oct
Partners: FDA (opens fda.gov)
Acquired by: Advanced Bionics (opens news.bostonscientific.com)Intelect Medical

Spec

WaveWriter Alpha SCS

Implant models

4 (2 rechargeable, 2 not)^R (reported)

Electrode contacts

16 or 32^R (reported)

Implant volume

20.1–36.6 cc^R (reported)

Pulse rate range

2–1,200 Hz^R (reported)

Max current

25.5 mA^R (reported)

SOLIS: ≥50% pain relief at 1 year

84% of patients^R (reported)