• 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
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    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
    Aspivix's Carevix Cervical Stabilizer Gains FDA OK

    Apyx Medical Submits 510(k) App for Renuvion APR Handpiece

    LivaNova Releases SenTiva DUO VNS for Drug-Resistant Epilepsy

    CGM Devices Could Become Main Glucose Monitoring Solution in U.S.

    New Device Developed to Non-Invasively Measure Cervical Nerve Activity
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Reflections on 2022 and What’s Ahead for Medtech: MPO Sounding Board

    3 Ways to Prepare for ISO 13485/Part 820 Harmonization

    A New Home for Theranos' Elizabeth Holmes?

    Health Cost Drivers for Large Employers

    Braving Change: Facing Fears in the Midst of Major Transitions
    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
    Arthur G. Russell Co. Inc., The

    Fusion Biotec Inc.

    LEMO USA Inc.

    NDH Medical Inc.

    Medbio LLC
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Onshoring Medical Device Manufacturing Can Strengthen Supply Chains

    How Artificial Intelligence Can Combat Key Issues Impacting Healthcare

    Why Advanced Sensors Are Crucial Within Medical Pumps

    How Artificial Intelligence Could Help Prevent 80% of Chronic Diseases

    4 Ways to Use Injection Molding in Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Arthur G. Russell Co. Inc., The

    Fusion Biotec Inc.

    LEMO USA Inc.

    NDH Medical Inc.

    Medbio LLC
    • 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

    Study Confirms Benefits of ZOLL's Implantable Sleep Apnea Device

    Data show sustained improvement in sleep disordered breathing, arousals, sleep architecture, and daytime sleepiness through five years.

    Related Content
    • Johari Digital Healthcare Ltd.
    • Nissha Medical Technologies
    • JK Medirise-Disposable Medical Device Company
    • sfm medical devices GmbH
    • Heraeus Medevio
    Business Wire07.19.21
    ZOLL Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, announced the publication of five-year results from the remedē System Post Approval Study. The data show sustained safety and efficacy of transvenous phrenic nerve stimulation for the treatment of moderate to severe central sleep apnea (CSA). The remedē System, the only implantable device approved by the U.S. Food and Drug Administration (FDA) to treat moderate to severe CSA in adult patients with reduced cardiac function,1 was developed by Respicardia Inc., which was acquired by ZOLL in April 2021.
     
    The Post Approval Study was led by Dr. Maria Rosa Costanzo, principal investigator for the Pivotal Trial of the remedē System and medical director at Edward Hospital Center for Advanced Heart Failure and Heart Failure Research at Advocate Heart Institute, with contributions from Dr. Shahrokh Javaheri, Dr. Piotr Ponikowski, Dr. Olaf Oldenburg, Dr. Ralph Augostini, Dr. Lee Goldberg, Dr. Christoph Stellbrink, Dr. Henrik Fox, Dr. Alan Schwartz, Dr. Sanjaya Gupta, Scott McKane, Timothy Meyer, and Dr. William Abraham.
     
    The five-year data show sustained improvements from baseline that were highly consistent with the previously published six-, 12-, 24-, and 36-month results.2 The five-year results include:3,4
     
    • Ninety-six percent reduction in central apneas
    • Overall apnea hypopnea index (AHI) reduced by 22 events/hour of sleep
    • Arousals reduced by 14 events/hour of sleep
    • 14 percentage point (absolute) increase in deep sleep (N2–REM) and a 19 percentage point decrease in light stage sleep (N1)
    • Sustained improvement in daytime sleepiness
    • Consistent safety, in line with previously published data
     
    “It is an important milestone for a therapy to demonstrate sustained patient safety and benefit over five years,” said Dr. Robin Germany, chief medical officer of ZOLL Respicardia. “Phrenic nerve stimulation continues to show a significant and durable improvement in patient outcomes, including reduction in sleep apnea events, improvement in sleep architecture, and improvements in quality of life metrics. We congratulate all of the coauthors, study investigators, and patients who have contributed to the data collection and publication of this five-year study. We will continue to advance research on central sleep apnea and transvenous phrenic nerve stimulation as we increase access to the therapy for patients in need.”
     
    “Patients with central sleep apnea have historically been underserved, both in terms of research into the disease and the development of effective therapies designed to treat it,” said Peter Sommerness, president of ZOLL Respicardia. “Transvenous phrenic nerve stimulation continues to deliver remarkable results, giving clinicians and patients confidence in the long-term safety and efficacy of the therapy.”
     
    The remedē System was approved to treat moderate to severe CSA in adult patients by the FDA in 2017.1 The remedē System is an implantable device that activates automatically each night to stimulate a nerve in the chest (phrenic nerve) that sends signals to the breathing muscles (diaphragm) to help restore a normal breathing pattern.5 The Post Approval Study followed patients from the pivotal trial through five years post implant.
     
    Central sleep apnea (CSA) is a serious breathing disorder that disrupts the normal breathing pattern during sleep and negatively affects sleep quality, quality of life, and is associated with poor outcomes. CSA results from the brain's inability to send appropriate signals to the respiratory muscles to stimulate breathing. Many patients with CSA also have heart disease, especially heart failure.6 Within this population, patients with CSA are at increased risk for hospitalizations and even death.7,8
     
    References
    1 FDA PMA P160039. https://www.fda.gov/medical-devices/recently-approved-devices/remeder-system-p160039
    2 Fox H., et al. Sleep. 2019;42:11. https://doi.org/10.1093/sleep/zsz158
    3 Costanzo MR, Javaheri S, Ponikowski P, Oldenburg O, Augostini R, Goldberg LR, Stellbrink C, Fox H, Schwartz AR, Gupta S, McKane S, Meyer TE, Abraham WT. Transvenous Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea: Five-Year Safety and Efficacy Outcomes. Nat Sci Sleep. 2021;13:515-526 https://doi.org/10.2147/NSS.S300713
    4 Javaheri S., et al. Chest. 2020;158:4(suppl): A2412-A2413.
    5 Costanzo M.R., et al. The Lancet. 2016;388:974–82.
    6 Bekfani T, Abraham WT. Europace. 2016;18(8):1123–34. Epub 2016 May 26.
    7 Khayat R, et al. J Card Fail. 2012;18:534–40.
    8 Khayat, R et al. European Heart J. 2015;36 1463–69.
     
     
    Suggested For You
    Johari Digital Healthcare Ltd. Johari Digital Healthcare Ltd.
    Nissha Medical Technologies Nissha Medical Technologies
    JK Medirise-Disposable Medical Device Company JK Medirise-Disposable Medical Device Company
    sfm medical devices GmbH sfm medical devices GmbH
    Heraeus Medevio Heraeus Medevio
    Simbex Simbex
    Hobson & Motzer Inc. Hobson & Motzer Inc.
    Anjon Medical Technologies Anjon Medical Technologies
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    High Tech Turning Co. Inc. High Tech Turning Co. Inc.
    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

    Related Buyers Guide Companies

    • Johari Digital Healthcare Ltd.

      ...
      Kamal Kumawat, Marketing Manager 12.06.22

    • Nissha Medical Technologies

      ...
      Amy Jeary, Market Development Manager 11.18.22

    • JK Medirise-Disposable Medical Device Company

      ...
      Ketan Munjani, Marketing Manager 11.17.22


    • sfm medical devices GmbH

      ...
      Albert Busch, Head of Marketing 11.11.22

    • Heraeus Medevio

      Heraeus Medevio

      Heraeus is a globally active precious metals and technology Group with firm roots in Germany, headquartered in Hanau near Frankfurt.
      Megan Erd, Global Marketing Coordinator 11.02.22

    Loading, Please Wait..

    Trending
    • Study: Smartphone Therapeutic Helps Improve Fibromyalgia In Patients
    • The Future Of Biomedical Engineering Advancements
    • Environmental Sustainability Becoming Increasingly Important To Medtech Industry
    • Medtronic's Recall Of Mahurkar Catheters Is Class I
    • A New Approach To Post-Market Surveillance
    Breaking News
    • Aspivix's Carevix Cervical Stabilizer Gains FDA OK
    • Apyx Medical Submits 510(k) App for Renuvion APR Handpiece
    • LivaNova Releases SenTiva DUO VNS for Drug-Resistant Epilepsy
    • CGM Devices Could Become Main Glucose Monitoring Solution in U.S.
    • New Device Developed to Non-Invasively Measure Cervical Nerve Activity
    View Breaking News >
    CURRENT ISSUE

    November 2022

    • MPO's 2022 Year in Review
    • Fine Print: A Discourse on Additive Manufacturing
    • Grab and Go: Examining the Thrombectomy Device Market
    • 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

    GOED Elects New Board Officers for 2023
    Aspire Hires Darrec Jones as VP of Business Development
    Pycnogenol Supplementation Linked to Better Hair Density in Menopausal Women
    Coatings World

    Latest Breaking News From Coatings World

    PPG Completes COLORFUL COMMUNITIES Project in Denmark
    10 Partners of the Automotive Industry Form JV, Cofinity-X
    BASF Recognized as Top Company for Supplier Diversity
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Aspivix's Carevix Cervical Stabilizer Gains FDA OK
    Apyx Medical Submits 510(k) App for Renuvion APR Handpiece
    LivaNova Releases SenTiva DUO VNS for Drug-Resistant Epilepsy
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Bionova Expansion Project to Quadruple GMP Biologics Manufacturing Capacity
    Steriline Provides Fill-Finish Solution for Berkshire Sterile Manufacturing
    Merck Revenues up 22% for the Year to $59.3B
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Mielle Unveils Haircare Bundles Inspired by Amazon Original Series Harlem
    Kering Appoints Former L’Oréal and Estée Lauder Exec as CEO of Kering Beauté
    Paco Rabanne, Fashion & Perfume Designer, Dies
    Happi

    Latest Breaking News From Happi

    Perfect Corp. Launches 'YouCam Enhance'
    Ariana Grande Agrees to Purchase Assets Tied to REM Beauty from Forma Brands
    Elf Cosmetics Grows Net Sales By 49% in Q3
    Ink World

    Latest Breaking News From Ink World

    Roland DGA Announces Key Changes to Leadership Team
    Ball Reports 2022 Results
    3D Printing Materials Market Worth $7.9 Billion by 2027: MarketsandMarkets
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    MM Packaging adds first Nilpeter press for Dublin site
    Polytag develops new UV tag reading technology
    Enterprise Print Group adds Screen Truepress Jet L350UV SAI E
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Kimberly-Clark Supports Period Poverty Initiative in Australia
    Suominen Reports Q4, Full Year Results
    Qvin Menstrual Blood Diagnostic Device Receives FDA Approval in Thailand
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Toetal Solutions Secures $1.8 Million in New Financing
    Adrian Tyndall Joins Axogen's Board of Directors
    ADSM-Synchro Medical Acquired by Tyber Medical
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Zebra Provides East West Shrine Bowl with RFID Tracking Technology
    AAAS Elects Three ORNL Scientists as Fellows
    Flex Recognized as One of Fortune World’s Most Admired Companies 2023

    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