• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Sensing Technology Drives the Future of Medical Care

    New and Developing Diabetes Technologies Offer 'Sweet Relief'

    Discussing Matters of Substance in Medtech Materials

    Medical Device Testers Are Caught Up in a Whirlwind

    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    Getinge iCast Receives FDA Premarket Approval

    Tessy Plastics Corp. Celebrates 50th Anniversary

    Carium Expands Customization Options with Care Pathways

    InBody Supplying U.S. Marine Corps With Body Composition Analysis Devices

    Blackford and Brainomix Collaborate to Improve Stroke Care
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Sensing Technology Drives the Future of Medical Care

    New and Developing Diabetes Technologies Offer 'Sweet Relief'

    Discussing Matters of Substance in Medtech Materials

    Medical Device Testers Are Caught Up in a Whirlwind

    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    CR-SOP Neurotechnology Helps to Achieve ‘Sound’ Sleep

    Inside the Hospital Value Analysis Committee

    Face Time: Why Getting Engineers Out of the Lab Is Good for Business

    Common Paratubing Pitfalls and How to Avoid Them

    During Times of Uncertainty, Create Business Value with an Optimized Workforce
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Forefront Medical Technology

    LEMO USA Inc.

    Cirtec Medical

    NDH Medical Inc.

    Fusion Biotec Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3D Printing Medical Devices Revolutionized Manufacturing

    5 Current Trends in Medical Device Security

    How Advanced Sensors Improve Design & Functionality of Respiratory Care Equipment

    Sourcing Silicone Parts: Injection Mold or 3D Print?

    Cybersecurity in Healthcare: Getting on the Right Track
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Forefront Medical Technology

    LEMO USA Inc.

    Cirtec Medical

    NDH Medical Inc.

    Fusion Biotec Inc.
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    Medtronic Submits InterStim Micro Neurostimulator and SureScan MRI Leads to FDA

    Pending approval, the devices could be available Spring 2020.

    Medtronic Submits InterStim Micro Neurostimulator and SureScan MRI Leads to FDA
    The rechargeable InterStim Micro device works by sending electrical impulses to the sacral nerves, normalizing the connections between the brain, bladder, and bowel. Image courtesy of Medtronic.
    Medtronic plc10.07.19
    Medtronic plc has filed a pre-market approval (PMA) supplement with the United States Food and Drug Administration (FDA) for approval of its InterStim Micro neurostimulator and also its InterStim SureScan MRI leads. InterStim Micro is a rechargeable, implantable sacral neuromodulation (SNM) device to treat patients affected by overactive bladder, urinary urge incontinence, unobstructed urinary retention, and fecal incontinence. The SureScan leads, which will be used in future implants of the recharge-free InterStim II system and rechargeable InterStim Micro system, are designed to provide full-body 1.5 and 3 Tesla MRI conditional labeling, pending FDA approval.
     
    The rechargeable InterStim Micro device works by sending electrical impulses to the sacral nerves, normalizing the connections between the brain, bladder, and bowel. It is 80% smaller than the current recharge-free InterStim II neurostimulator and could reduce the need for battery replacement surgeries due to its life of 15 years. Additionally, the SureScan full-body conditional MRI leads will enable patients to undergo imaging procedures that were not previously indicated under the current FDA approval for the InterStim II system.
     
    "The FDA submission for InterStim Micro and SureScan MRI leads is a significant milestone for Medtronic and a leap forward in our 20-year history of leadership in sacral neuromodulation," said Brooke Story, vice president and general manager of the Pelvic Health & Gastric Therapies business, which is part of the Restorative Therapies Group at Medtronic. "Our ultimate goal is to provide safe and effective treatments to patients affected by bladder and bowel dysfunction, and ensure they have a choice in selecting the most appropriate therapy for their unique situation."
     
    This submission, pending regulatory approval from the FDA, would position the company to achieve approval for the InterStim Micro system and SureScan MRI leads in the spring of 2020, following a standard 180-day review process. The InterStim Micro system and SureScan MRI leads are not yet available for sale in the United States.
    Related Searches
    • president
    • urinary retention
    • medtronic plc
    • neurostimulator
    Related Knowledge Center
    • Neurological
    Suggested For You
    MEDICAL & BIOTECH MANUFACTURING MEDICAL & BIOTECH MANUFACTURING
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    Breakthrough Device Designation Granted for New Neuromodulation Platform Breakthrough Device Designation Granted for New Neuromodulation Platform
    Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    Accu-Tube Appoints Matthew Haddle as CEO Accu-Tube Appoints Matthew Haddle as CEO
    First CellFX Procedure Performed in Canada First CellFX Procedure Performed in Canada
    Turner Imaging Systems Announces International Expansion Turner Imaging Systems Announces International Expansion
    RedDress’ ActiGraft System Receives New FDA Clearance RedDress’ ActiGraft System Receives New FDA Clearance
    Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings
    MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021 MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021
    Boston Scientific Agrees to Acquire Devoro Medical Boston Scientific Agrees to Acquire Devoro Medical
    CE Mark Granted to Predictive Software for Kidney Allograft Survival CE Mark Granted to Predictive Software for Kidney Allograft Survival
    Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech
    OmniVision Debuts Industry’s First 8 Megapixel Medical-Grade Image Sensors OmniVision Debuts Industry’s First 8 Megapixel Medical-Grade Image Sensors
    FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests

    Related Literature / Brochures

    • MEDICAL & BIOTECH MANUFACTURING

      ISO 13485:2016 • FDA Registered

    • BMP Medical - Delivering Custom Plastics Manufactured Solutions

      BMP Medical - Delivering Custom Plastics Manufactured Solutions

      Medical Contract Manufacturing, Design, Assembly & Packaging

    • Breakthrough Device Designation Granted for New Neuromodulation Platform

      Breakthrough Device Designation Granted for New Neuromodulation Platform

      In a pilot study treating refractory epilepsy with Neuroelectrics’ Starstim platform, patients experienced a 44 percent median reduction in seizure frequency.
      Business Wire 09.22.21


    • Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

      Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

      Neela Paykel is serving as general counsel and Tom Teisseyre assumes the chief product officer position.
      Business Wire 09.22.21

    • Tubing & Extrusion
      Accu-Tube Appoints Matthew Haddle as CEO

      Accu-Tube Appoints Matthew Haddle as CEO

      Haddle has a track record of leading organizations through strategic expansions across the medical device, aerospace, and industrial sectors.
      Accu-Tube 09.22.21

    Loading, Please Wait..

    Trending
    • Victoria Carr-Brendel Joins Vicarious Surgical Board
    • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
    • InBody Supplying U.S. Marine Corps With Body Composition Analysis Devices
    • The Future Of Biomedical Engineering Advancements
    • Tessy Plastics Corp. Celebrates 50th Anniversary
    Breaking News
    • Getinge iCast Receives FDA Premarket Approval
    • Tessy Plastics Corp. Celebrates 50th Anniversary
    • Carium Expands Customization Options with Care Pathways
    • InBody Supplying U.S. Marine Corps With Body Composition Analysis Devices
    • Blackford and Brainomix Collaborate to Improve Stroke Care
    View Breaking News >
    CURRENT ISSUE

    March 2023

    • Sensing Technology Drives the Future of Medical Care
    • New and Developing Diabetes Technologies Offer 'Sweet Relief'
    • Discussing Matters of Substance in Medtech Materials
    • Medical Device Testers Are Caught Up in a Whirlwind
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    NPA: ‘Major Victory’ in Colorado After Amendment to Eating Disorder Bill
    GOOD Meat Receives FDA Go-Ahead for Cultured Meat
    IFF Achieves Industrial-Scale Production of Anaerobic Probiotic Strain
    Coatings World

    Latest Breaking News From Coatings World

    HOFFMANN MINERAL to Focus on Comprehensive Sustainability Strategy
    HMG and Prodrive Renew Technical Partnership
    Eastern Coatings Show Sets Schedule for Technical Papers
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Getinge iCast Receives FDA Premarket Approval
    Tessy Plastics Corp. Celebrates 50th Anniversary
    Carium Expands Customization Options with Care Pathways
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Willow, Suanfarma Complete Manufacturing Process for Cannabigerol
    Berkshire Sterile to Install nearly 1,500 solar panels at Massachusetts site
    Harm Reduction Therapeutics, Catalent Ink Naloxone Commercial Supply Pact
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Interpack 2023 Introduces New Special Areas and Activities
    eSalon Expands into Over 1,900 CVS Stores Nationwide
    The RealReal Discontinues Beauty Business
    Happi

    Latest Breaking News From Happi

    Inolex Launches Sustainable BTAC Replacement AminoSensyl Ultra MB
    A New Way To Measure Skin Barrier Function: Research
    P&G Patents Laundry Scent Additive
    Ink World

    Latest Breaking News From Ink World

    Eastern Coatings Show Announces Schedule for Technical Papers
    Pulse Roll Label Products Adds Sean Labas to Technical Sales Team
    Amcor, Nfinite Enter into Agreement on Recyclable Packaging
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    TLMI announces 2022 Eugene Singer Award winners
    Pulse Roll Label Products expands technical sales team
    Mark Andy introduces ProWORX Label Suite
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Heartland Polymers Begins Production in Alberta
    Zeta Polimeri Becomes Radici EcoMaterials
    Responsible Flushing Alliance Holds Annual Meeting
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    AI is Effective at Documenting Orthopedic Encounters in Hand Surgery
    3D LifePrints Rebrands to Insight Surgery & Launches New Business in Houston
    Companion Spine Closes $60.1 Million Series A Funding Round
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Midsummer, UCLA Collaborate on Perovskite-CIGS Tandem Solar Cells
    HID Reports on Reshaping the Security Industry
    Meyers Introduces New Function47 Division

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login