Axonics sacral neuromodulation (R20 / F15) by Boston Scientific: status and timeline

Milestones

Next · Axonics integrated into Boston Scientific portfolio

Axonics founded2012Complete.
Axonics R20 FDA approvalJan 2023Complete.
Axonics F15 FDA approvalMar 2022Complete.
Boston Scientific acquisition announced8 Jan 2024Complete.
Boston Scientific acquisition closes15 Nov 2024Complete.
Axonics integrated into Boston Scientific portfolioTarget Q4 2024Current milestone.

Most important updates

Boston Scientific completes $3.7B acquisition of Axonics15 Nov 2024

Upcoming

Q4 2024Axonics integrated into Boston Scientific portfolio (next)

Current obstacles

Medtronic InterStim dominanceMedtronic's InterStim is the established market leader; Axonics must demonstrate clinical equivalence or superiority.
Surgical implantation requiredBoth bladder and bowel control indications require a surgical procedure under anesthesia; this limits accessibility and patient acceptance.

Physics limits

Battery and device sizeEven advanced batteries store limited charge; longer functional life requires larger devices or frequent recharging.
Nerve signal variabilityIndividual sacral nerve anatomy and function vary widely, making patient selection and parameter tuning complex.

How it works

3 parts

Sacral nerve targeting

Electrodes on the sacral nerve

A small electrode is placed on the sacral nerve (S3) in the lower spine during a minimally invasive procedure. The nerve controls bladder and bowel function.

Electrical pulses

Mild stimulation restores communication

The implanted generator delivers mild electrical pulses to the nerve, restoring signaling between the brain and bladder or bowel.

Constant-current control

Adaptive output

Both systems use constant-current stimulation that automatically adjusts output to maintain consistent therapy despite body changes.

Spec sheet

Spec	Axonics sacral neuromodulation (R20 / F15)
R20 functional life in body	20+ years^R (reported)
R20 recharge frequency	Every 6–10 months for 1 hour^R (reported)
R20 form factor	5 cubic centimeters^R (reported)
F15 functional life in body	15+ years at typical parameters; 20+ years at lower energy^R (reported)
F15 form factor	10 cubic centimeters (20% smaller than competitors)^R (reported)
F15 MRI compatibility	1.5T and 3.0T whole-body scanners^R (reported)

^R reported by the company

Update log

1 update

Fri 15 Nov 2024

Major: Boston Scientific completes $3.7B acquisition of AxonicsPressCommercial

About Boston Scientific

The team behind Axonics sacral neuromodulation (R20 / F15)

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

Axonics sacral neuromodulation (R20 / F15)

R20 functional life in body

20+ years^R (reported)

R20 recharge frequency

Every 6–10 months for 1 hour^R (reported)

R20 form factor

5 cubic centimeters^R (reported)

F15 functional life in body

15+ years at typical parameters; 20+ years at lower energy^R (reported)

F15 form factor

10 cubic centimeters (20% smaller than competitors)^R (reported)

F15 MRI compatibility

1.5T and 3.0T whole-body scanners^R (reported)