• 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
    Adding Fabrication Capabilities: Additive Manufacturing for Production Parts

    Delivering the Goods: The Evolving World of Combination Products

    Anxious Undertones: The 2019 Year in Review

    From Art to Science: The Changing Face of Extrusion

    Exact Science: A Micromolding Roundtable
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    FDA OKs Roche's Nasal Swab MRSA Test

    Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs

    Eye Test for Parkinson's Gains Breakthrough Designation

    Biomerics Forms New Business Unit

    J&J's New Monofocal IOL for Cataract Patients with Astigmatism
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Adding Fabrication Capabilities: Additive Manufacturing for Production Parts

    Delivering the Goods: The Evolving World of Combination Products

    Anxious Undertones: The 2019 Year in Review

    From Art to Science: The Changing Face of Extrusion

    Exact Science: A Micromolding Roundtable
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    From Genome Sequencing to the World’s First Portable MRI

    An Update on Digital Health

    ‘If You’re Reading This, You Need to Be at This Meeting’

    Five Steps for Succeeding Globally in Medtech

    Unlocking Market Doors with Real-World Evidence
    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
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    FUTEK Advanced Sensor Technology Inc.

    Lyons

    RJG Inc.

    S-Y-M Products Company

    Fusion Biotec Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Understanding Key Processes for Mixing APIs with Silicone

    How to Minimize Color Variations in Your Medical Device

    Don’t Touch: Gesture Tech Is Reshaping How We Interact with Devices

    Revenue-Based Financing: A New Form of Growth Capital

    Pre-Filled Safety Syringes and the Self-Administration Trend
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    IQMS

    Lyons

    Command Medical Products Inc.

    Marox Corporation

    FUTEK Advanced Sensor Technology 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
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • 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

    FDA Approves the Inspire 3028 Neurostimulator for Sleep Apnea Treatment

    Inspire Medical Systems' technology is 40 percent smaller and 18 percent thinner than current neurostimulators.

    FDA Approves the Inspire 3028 Neurostimulator for Sleep Apnea Treatment
    Related CONTENT
    • Hologic Appoints President of EMEA and Canada
    • Johnson & Johnson Innovation, New York State, and New York Genome Center Launch JLABS in NYC
    • Verb Surgical Demonstrates First Digital Surgery Prototype
    • Trump’s 100-Day (Plus) Plan for Medtech M&A
    • The Consumerization of Healthcare
    Inspire Medical Systems Inc. 06.23.17
    Inspire Medical System Inc., manufacturer of the only U.S. Food and Drug Administration (FDA)-approved implantable device for obstructive sleep apnea (OSA), has received FDA approval for its next-generation device, the Inspire 3028 implantable pulse generator, which includes magnetic resonance conditional labeling, allowing patients to undergo magnetic resonance imaging (MRI) safely.
     
    “The continuous positive airway pressure (CPAP) intolerant patients I see want to lead active and engaging lives,” said Alan Kominsky, M.D., a practicing ENT-otolaryngologist at the Cleveland Clinic. “With conditional MRI labeling, the new Inspire device provides my OSA patients peace of mind now that MRIs are an option. Similar to approvals in the cardiac and neurological implantable device arenas, this labeling expansion is a welcome addition to the upper airway stimulation therapy.”
     
    In addition to the conditional MRI labeling, the newly approved implantable device provides many OSA patients with a size profile that meets the needs of patients who cannot use or get benefit from CPAP. The Inspire 3028 device is 40 percent smaller and 18 percent thinner than the current Inspire neurostimulator, which received FDA approval in April 2014. 
     
    “We have received consistent feedback from the medical community that providing the ability for patients to have an MRI is very important,” said Tim Herbert, president and CEO of Inspire Medical Systems. “We incorporated features to allow for an MRI and redesigned the device to have both a smaller footprint as well as being significantly thinner without compromising product functionality or device battery life which remains at about 11 years. We believe that the peace of mind and improved patient comfort with this next generation device will have a direct and positive impact on the commercial opportunity for Inspire therapy.”
     
    Inspire therapy is currently being implanted in more than 100 medical centers across the United States and over 25 centers in Europe. More than 1,700 patients worldwide are currently using Inspire therapy, and objective and subjective patient outcomes have proven the therapeutic benefit of the technology.
     
    Inspire also announced that two key publications have been issued in peer-reviewed medical journals further describing the safety and efficacy of Inspire therapy. First, the four-year long-term follow-up clinical data of patients in the STAR phase III pivotal trial was published last month in Otolaryngology–Head and Neck Surgery. The results of the four-year follow-up showed sustained quality of life improvements in patients who have used the therapy for over four years.
     
    Also published in Otolaryngology–Head and Neck Surgery (in April) was the first multi-center trial conducted to validate the results of the STAR trial. This second trial was conducted in Germany with 60 patients implanted with the Inspire device. The authors concluded that selective upper airway stimulation is a safe and effective therapy for patients with obstructive sleep apnea and represents a powerful option for its surgical treatment.
     
    “Inspire therapy is proving to be a valuable option for patients who are unable to tolerate CPAP,” said Kingman Strohl, M.D., professor of medicine at Case Western Reserve University School of Medicine and program director, Sleep Medicine at UH Cleveland Medical Center.  “I remain convinced that we will continue to see outstanding patient outcomes with the Inspire therapy system and am confident this next generation of smaller and thinner devices with conditional MRI labeling will be an important therapy for my untreated OSA patients.”
     
    
Inspire Upper Airway Stimulation therapy is an FDA-approved treatment for some people with moderate to severe OSA who are unable to use or get consistent benefit from continuous positive airway pressure. In contrast to CPAP, Inspire therapy is implanted inside the body and works with a patient's natural breathing process. Controlled by the small handheld sleep remote, the system includes a breathing sensor and a stimulation lead powered by a small battery. During sleep, the system senses breathing patterns and delivers mild stimulation to the tongue and other soft tissues of the throat to keep the airway open.
     
    Based in Minneapolis, Minn., Inspire Medical Systems develops OSA therapy. The company is privately held and investors include Amzak Health, Aperture Venture Partners, GDN Holdings, Johnson & Johnson, Kleiner Perkins Caufield & Byers, Medtronic plc, OrbiMed Advisors, Synergy Life Science Partners, TGap Ventures and U.S. Venture Partners.
    Related Searches
    • sleep
    • cardiac
    • president
    • johnson
    Suggested For You
    Applied BioCode Achieves ISO 13485:2003 Certification Applied BioCode Achieves ISO 13485:2003 Certification
    Johnson & Johnson Launches CareAdvantage Johnson & Johnson Launches CareAdvantage
    Class III Devices from 10,000 Feet: The Big Picture on Getting Premarket Approval Class III Devices from 10,000 Feet: The Big Picture on Getting Premarket Approval
    The Buck Starts Here The Buck Starts Here
    Disposable, Wearable Patch Effectively Detects Sleep Apnea Disposable, Wearable Patch Effectively Detects Sleep Apnea
    Avedro Nabs $42 Million in Funding, Opens New Manufacturing Facility Avedro Nabs $42 Million in Funding, Opens New Manufacturing Facility
    FDA Designates N8 Medical FDA Designates N8 Medical's CeraShield Endotracheal Tube as a Breakthrough Device
    Defibtech Selects New CEO Defibtech Selects New CEO
    Collaborating on Custom Materials Development Collaborating on Custom Materials Development
    Extractable/Leachable Chemistry Testing Strategies for Medical Devices Extractable/Leachable Chemistry Testing Strategies for Medical Devices
    SPR Therapeutics Appoints New Member to Board of Directors SPR Therapeutics Appoints New Member to Board of Directors
    Four Common Misperceptions of Accelerated FDA Approval Four Common Misperceptions of Accelerated FDA Approval
     FlowAid Receives FDA Clearance for the FA100 SCCD FlowAid Receives FDA Clearance for the FA100 SCCD
    Capillus Laser Therapy Caps Receive FDA Clearance for Over-the-Counter Use Capillus Laser Therapy Caps Receive FDA Clearance for Over-the-Counter Use
    FDA Clears Voxello FDA Clears Voxello's Speech Generation Device

    Related Breaking News

    • Diagnostics
      FDA OKs Roche

      FDA OKs Roche's Nasal Swab MRSA Test

      The cobas vivoDx MRSA test can detect the bacteria in as little as five hours.
      U.S. Food and Drug Administration 12.06.19

    • Diagnostics | Digital Health | Software & IT
      Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs

      Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs

      Aim is to help pathologists identify, quantify, and characterize cancer in tissue samples and make precise diagnoses more efficiently.
      Philips 12.05.19

    • Diagnostics | Neurological
      Eye Test for Parkinson

      Eye Test for Parkinson's Gains Breakthrough Designation

      The RightEye Vision System identifies ocular tremors that may help to detect the disease at an earlier stage.
      PR Newswire 12.05.19


    • Tubing & Extrusion
      Biomerics Forms New Business Unit

      Biomerics Forms New Business Unit

      Ends joint venture with ATL Technology.
      Biomerics LLC 12.05.19

    • Surgical
      J&J

      J&J's New Monofocal IOL for Cataract Patients with Astigmatism

      TECNIS Toric II 1-Piece IOL features more surface texture and friction on IOL haptics.
      PR Newswire 12.05.19

    • Patient Monitoring
      FDA OKs MolecuLight

      FDA OKs MolecuLight's Handheld Fluorescence Imaging Device

      MolecuLight i:X enables real-time POC visualization of fluorescence in wounds, measures wounds, and digitally records all images and area measurements.
      PR Newswire 12.05.19


    • Surgical
      First Surgical Robot to Achieve Breakthrough Status Granted to Vicarious Surgical

      First Surgical Robot to Achieve Breakthrough Status Granted to Vicarious Surgical

      The company also appointed former Verb Surgical leader Scott Huennekens to its Board of Directors.
      PR Newswire 12.05.19

    • 3D/Additive Manufacturing
      Tracheal Construct Bioprinted with Multiple Materials

      Tracheal Construct Bioprinted with Multiple Materials

      WFIRM scientists printed different designs of smooth muscle and cartilage regions in artificial tracheal substitutes.
      Wake Forest Baptist Medical Center 12.05.19

    • Packaging & Sterilization
      Viant to Halt EtO Sterilization at Michigan Plant by End of Year

      Viant to Halt EtO Sterilization at Michigan Plant by End of Year

      EGLE had been investigating over the past year and issued Viant several violations for inadequate capture and control of ethylene oxide emissions.
      Michigan Department of Environment, Great Lakes, and Energy (EGLE) 12.04.19


    • Surgical
      Grifols Introduces its First Plasma Protein-Based Biosurgery Product

      Grifols Introduces its First Plasma Protein-Based Biosurgery Product

      VISTASEAL, a fibrin sealant developed for biosurgical bleeding-control, contains a combination of two plasma proteins.
      Grifols 12.04.19

    • Diagnostics | Neurological
      RSNA News: MaxQ AI Expands Partnership with GE

      RSNA News: MaxQ AI Expands Partnership with GE

      MaxQ AI’s ACCIPIO ICH and Stroke platform will be integrated into GE Healthcare’s PACS solution.
      MaxQ Al 12.04.19

    • Diagnostics | Neurological
      RSNA News: MaxQ AI to Offer Accipio Applications on Blackford Platform

      RSNA News: MaxQ AI to Offer Accipio Applications on Blackford Platform

      Represents cost savings and increased quality of care.
      MaxQ AI 12.04.19

    • Surgical
      Levita Magnetics Reaches 1,000th Magnetic Surgery Milestone

      Levita Magnetics Reaches 1,000th Magnetic Surgery Milestone

      Technology offers patients a less invasive alternative in surgical procedures.
      Business Wire 12.04.19

    • New CEO for Modulim

      New CEO for Modulim

      Company promotes from within to fill top spot.
      Business Wire 12.04.19

    • Diagnostics
      Hyperfine Introduces World’s First Point-of-Care MRI System

      Hyperfine Introduces World’s First Point-of-Care MRI System

      The company's portable MRI is 20 times less costly, 35 times lower power, and 10 times lighter than the most popular current MRI machines.
      Business Wire 12.04.19


    Breaking News
    • FDA OKs Roche's Nasal Swab MRSA Test
    • Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs
    • Eye Test for Parkinson's Gains Breakthrough Designation
    • Biomerics Forms New Business Unit
    • J&J's New Monofocal IOL for Cataract Patients with Astigmatism
    View Breaking News >
    CURRENT ISSUE

    November/December 2019

    • Adding Fabrication Capabilities: Additive Manufacturing for Production Parts
    • Delivering the Goods: The Evolving World of Combination Products
    • Anxious Undertones: The 2019 Year in Review
    • View More >
    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    International Scientific Society Calls for Omega-3 Blood Testing in Future Research
    Pharmactive Affron Saffron May Help Relieve Depression Symptoms
    Warmer Temperatures Could Lead to Concerning Levels of Arsenic in Rice
    Coatings World

    Latest Breaking News From Coatings World

    Cristo Rey High School Educator Named 2019 Axalta All-Pro Teacher of the Year
    Michelman Makes United Way of Greater Cincinnati’s List of Top 25 Corporate Campaigns
    BCF: Coatings Industry Reports Record Improvement in Waste, Recycling, Accident Rates
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FDA OKs Roche's Nasal Swab MRSA Test
    Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs
    Eye Test for Parkinson's Gains Breakthrough Designation
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Almac Awarded $1M BMGF Grant
    Vivera Pharma, Parexel Ink Clinical Services Agreement
    MedPharm Triples Capacity at RTP Site
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    WWP Wins Three NJPEC Awards
    Cat-Themed Beauty Collection to Launch in Japan
    Pantone Names Classic Blue the 2020 Color of the Year
    Happi

    Latest Breaking News From Happi

    Lip Lab Opening in Brooklyn
    Raining Rose Expands Exec Team
    Scott’s Sells Personal Care Production Site
    Ink World

    Latest Breaking News From Ink World

    ePac Flexible Packaging Expands into Asia Pacific Market
    Haney, HP Developing Sustainable Fashion Packaging for Heron Preston
    Addipel Moves to New HQ, Expands Production Facility
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    HP teams with Haney for sustainable packaging
    Tags & Labels Printing adds Heidelberg’s Versafire EP
    Austrian converter installs first Nilpeter press
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Thrace to Relocate U.S. Capacity
    FiltXPO Speaker Line-Up Announced
    Nölken Incorporates Sustainable Wipes Packaging
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Orthofix Appoints New Spine Business Leader
    Viant to Halt EtO Sterilization at Michigan Plant by End of Year
    Synaptive Medical's Modus V Expands Into Spine Market
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    IDTechEx Show! Announces Graphene Award Winner
    OE-A Continues to Bring Future of Printed Electronics to CES 2020
    Avancis, Smit Thermal, HZB, CNRS, Solliace Team for Higher Efficiencies in CIGS

    Copyright © 2019 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.