Medtronic Receives FDA Approval to Launch Clinical Study for Implantable Tibial Neuromodulation Therapy for Bladder Incontinence

 
 

 

 

- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced approval from the U.S. Food and Drug Administration (FDA) to proceed with an investigational device exemption (IDE) trial to evaluate its internally developed implantable tibial neuromodulation (TNM) device — a therapy designed to provide relief from symptoms of bladder incontinence. The TITAN 1 Feasibility Study is a prospective, multicenter, feasibility study to characterize the procedure for the implantable TNM device in subjects with bladder incontinence.

 

More than 37 million adults in the United States — almost one in six — suffer from overactive bladder (OAB) 1,2 . Of those, 4.5 million are candidates for an advanced therapy, yet only 5% receive treatment 3 . Implantable TNM aims to expand access to therapies for incontinence for more physicians and their patients.

 

For 25 years, Medtronic has pioneered sacral neuromodulation (SNM) therapy delivered by its implantable primary cell InterStim™ systems. Later the company enhanced its portfolio with the addition of PTNM delivered through the NURO™ system. In recognition that offering physicians and patients a choice between neuromodulation devices would help continue to expand access to the therapy, Medtronic further augmented its portfolio with the introduction of a rechargeable SNM device — InterStim™ Micro. Medtronic is the only company to offer a suite of neuromodulation options for the treatment of incontinence.

 

"Our goal is to stay at the forefront of therapy innovation, and we believe implantable TNM is an important part of the future of therapy for bladder incontinence," said Brett Wall , executive vice president and president of the Neuroscience Portfolio at Medtronic. "We remain completely committed to our sacral neuromodulation portfolio because this option is, and will continue to be, the best choice for many patients. Implantable TNM aims to be an extension of our belief that choice matters. No two patients are the same and their therapy should not be either."

 

Medtronic's combination of experience with implantable neuromodulation, its existing proprietary technology platforms and its proven effectiveness of PTNM therapy — as shown in the RESET study 4 — uniquely positions the company to develop a new TNM option for the market.

 

Implantable TNM stimulates the posterior tibial nerve near the ankle, transmitting electrical impulses that regulate neural activity of the bladder. Twenty patients from eight sites in the U.S. will receive a device and will be followed for 12 months. Enrollment is anticipated to begin in May 2021 .

 

   About Medtronic
 
Medtronic plc ( www.medtronic.com ), headquartered in Dublin, Ireland , is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

 

  Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.  

 

  1 Stewart WF, et al. Prevalence and burden of overactive bladder in the United States . World J Urol. 2003 May;20(6):327-336.
2 United Nations, Department of Economic and Social Affairs, Population Division (2011). World Population Prospects: The 2010 Revision, CD-ROM Edition.
3 Leede Research, "Views on OAB: A Study for the National Association of Continence." December 16, 2015 .
4 Kobashi K, Nitti V, Margolis E et al. A prospective study to evaluate efficacy using the NURO percutaneous neuromodulation system in drug naive patients with overactive bladder syndrome. Urology. 2019;131:77-82.

 
 
        
 

   Contacts:   

 
 
 

  Katie Genereux  

 
 

  Ryan Weispfenning  

 
 

  Public Relations  

 
 

  Investor Relations  

 
 

  +1-763-514-0162  

 
 

  +1-763-505-4626  

 
 
 

 

 
 

  Medtronic plc (PRNewsfoto/Medtronic plc) 

 
 

 

 

 

 
 
 

 Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-receives-fda-approval-to-launch-clinical-study-for-implantable-tibial-neuromodulation-therapy-for-bladder-incontinence-301277263.html  

 

SOURCE Medtronic plc

 
 

News Provided by PR Newswire via QuoteMedia

The Conversation (0)
illustration of brain and cell phone.

BlinkLab Completes First Patient Test for US Autism Diagnostic Study

Digital healthcare company BlinkLab (ASX:BB1) has tested the first patient in its US autism diagnostic study, which is geared at validating the company's Dx1 test as a diagnostic aid for clinicians.

BlinkLab states in its Wednesday (March 12) release that the study is the largest digital diagnostic trial for autism in the US, with its aim being to support the early detection of developmental conditions like autism.

The first patient test took place at PriMED Clinical Research in Dayton, Ohio. PriMED, a division of PriMED Physicians, is one of two clinical sites selected for the study’s initial phase, which is targeting 100 patients.

Keep reading...Show less
HeraMED Signs Strategic Collaboration Agreement with Garmin Health

HeraMED Signs Strategic Collaboration Agreement with Garmin Health

HeraMED Limited (ASX: HMD), a medical data and technology company leading the digital transformation of maternity care, is delighted to announce it has entered into a collaboration agreement with Garmin (NYSE: GRMN), a leading global provider of smartwatches and GPS-enabled products, aimed at enhancing remote pregnancy monitoring and expanding the range of health data available to expectant mothers and their healthcare providers.

Keep reading...Show less
Cardiologist wearing virtual reality glasses.

2 Biggest Medical Device ETFs in 2025

Exchange-traded funds (ETFs) are a popular investment strategy, and generally contain a variety of publicly traded companies under one stock symbol, often with a focus on a specific sector.

Depending on the ETF, investors may be able to track up-and-coming companies, get exposure to top firms or a mix of both. Aside from stocks, some ETFs also track commodities or bonds.

In the healthcare industry, medical device ETFs bring together companies that go to great lengths to develop pharmaceutical-based technology that can improve the lives of patients.

Keep reading...Show less
Cyclomedica

Cyclopharm Signs US Agreement with HCA Healthcare for Technegas®

Cyclopharm Limited (ASX: CYC) is pleased to announce the signing of a major contract with Hospital Corporation of America Healthcare (HCA), one of the largest single healthcare providers in the United States. This agreement marks a significant milestone for the company which will allow the deployment of Technegas® in up to 169 nuclear medicine departments across HCA’s extensive network.1

Keep reading...Show less
CONNEQT App Launches in USA as Pulse Deliveries Commence

CONNEQT App Launches in USA as Pulse Deliveries Commence

Cardiex Limited (CDX:AU) has announced CONNEQT App Launches in USA as Pulse Deliveries Commence

Download the PDF here.

Female doctor with clipboard talking to smiling female patient at hospital.

Revolutionizing Women's Health: Antifungal Innovation Brings New Investment Opportunities

The intersection of women's health and antifungal innovation represents a pivotal moment in healthcare, offering both transformative medical advancements and compelling investment opportunities.

The groundbreaking developments in antifungal treatments specifically targeting women's health issues present a substantial market potential, resulting in rising investor interest in this rapidly evolving sector.

Despite comprising half the global population, women face unique health challenges that have historically received insufficient attention and investment. Among these health challenges, vaginal candidiasis stands out as a persistent and widespread issue affecting millions of women worldwide.

Keep reading...Show less

Latest Press Releases

Related News

×