Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Views
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

Axonics Modulation touts results of sacral neuromodulation study

February 21, 2019 By Nancy Crotti

Axonics Modulation Technologies (NSDQ:AXNX) announced positive top-line results from a pivotal study of its novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction.

The clinical study demonstrated that patients implanted with the Axonics r-SNM system experienced clinically meaningful and statistically significant improvements in urinary urgency incontinence (UUI) symptoms and quality of life, according to the Irvine, Calif.-based company. The study also met all secondary endpoints, and no serious device-related adverse events were reported.

The129-patient, single-arm, prospective, multi-center, unblinded pivotal clinical study was approved under an FDA Investigational Device Exemption (IDE). It was conducted in 14 centers in the U.S. and five centers in Western Europe.

All patients were implanted with a tined lead and the Axonics neurostimulator. Investigators collected efficacy data using a three-day bladder diary, a validated quality of life questionnaire, and a satisfaction questionnaire. Patients with at least 50% reduction in urgency incontinence episodes at follow-up visits as compared to baseline were considered therapy responders.

At six months, 90% of all implanted patients were therapy responders, including 80% of therapy responders with a ≥75% reduction in urgency incontinence episodes of which 34% were completely dry. Across all patients, urgency incontinence episodes per day dropped from 5.6 ± 0.3 (mean ± standard error) at baseline to 1.3 ± 0.2 at six months (p<0.0001). Patients averaged statistically and clinically significant improvement on the quality-of-life questionnaire score (34 points) at six months as compared to baseline and 93% of all implanted patients reported satisfaction with their r-SNM therapy.

“This successful clinical study marks an important milestone on our path to gaining FDA approval,” said Axonics chief medical officer Karen Noblett, M.D., in a prepared statement. “Historically, SNM therapy has only been available with a non-rechargeable implanted neurostimulator with an average lifespan of four years, requiring replacement surgery due to depletion of the neurostimulator battery. We believe that, in addition to reducing costs for patients and payors, the miniaturized 5cc rechargeable Axonics system, qualified to last in the body for at least 15 years, can significantly increase adoption of SNM therapy.”

Axonics filed a premarket approval application and interim clinical data from the study with FDA in December 2018. The company said it intends to file the six-month clinical data with the agency this week.

Related Articles Read More >

ZeroTo510 opens accelerator applications, expands device programming
Min-Vasive Medtech: Live interviews and audience Q&As with minimally invasive engineers from Edwards Lifesciences, Jupiter Endo and Compremium
PrecisionX Group buys Hudson Technologies
PSN Labs expands ISO 13485 certification to design and development
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Views
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe