• 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
    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends

    Power Trip: A Discussion of Custom Medical Electronics

    The MDR Transition: An Opportunity for Design Change?

    Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing
    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
    Heather Danks Named Chief Technology Officer at LEX Diagnostics

    Vitalchat Awarded Patent for Patient Monitoring, Bandwidth Conservation Tech

    South Korean Regulators Authorize Expanded NeuroStar TMS Indications

    Ian T. Meredith Joins Avertix Medical’s Board

    Hologic, Bayer Team Up for Contrast-Enhanced Mammography
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends

    Power Trip: A Discussion of Custom Medical Electronics

    The MDR Transition: An Opportunity for Design Change?

    Preserve and Protect: Sustainability Initiatives for Medtech Manufacturing
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Medtech’s Most Powerful M&A Drivers

    The Link Between Medtech and Connected Medical Devices

    Is the FTC Partly Responsible for Muted M&A Activity?

    Holistic Risk Management: Navigating the Future’s Uncertainties

    Defining End of Life for Medical Devices
    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
    LEMO USA Inc.

    NDH Medical Inc.

    Halkey-Roberts Corporation

    Medbio LLC

    Providence Enterprise USA Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    A One-Stop-Shop, Turnkey Solution Is Paramount for Success

    How Additive and Subtractive Manufacturing Are Revolutionizing the Medical Device Industry

    Medical Device Commercialization: It’s What, Not When, to Transfer to Manufacturing

    How In Silico Simulations Can Slash Medical Device Development Risk

    The Top 7 AI Applications Transforming Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    LEMO USA Inc.

    NDH Medical Inc.

    Halkey-Roberts Corporation

    Medbio LLC

    Providence Enterprise USA 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

    FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers

    Portfolio of heart failure devices offers effective pacing and access to the most advanced diagnostic imaging procedures.

    FDA Approval for Medtronic’s MR-Conditional Quadripolar CRT-Pacemakers
    These devices allow patients to receive MRI (magnetic resonance imaging) scans in either 1.5 or 3 Tesla (T) machines.
    Medtronic plc05.11.17
    Medtronic plc has received U.S. Food and Drug Administration (FDA) approval for a portfolio of quadripolar cardiac resynchronization therapy-pacemakers (CRT-Ps) that improve therapy delivery for patients with heart failure. These devices also allow patients to receive MRI (magnetic resonance imaging) scans in either 1.5 or 3 Tesla (T) machines. The Percepta Quad CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan and Solara Quad CRT-P MRI SureScan are expected to be available commercially in the United States in early summer 2017.
     
    “These new pacemakers allow clinicians to provide more personalized therapy treatment options,” said Anne B. Curtis, M.D., chair of the Department of Medicine, University at Buffalo, NY. “Their ability to automatically adjust pacing to meet the patient’s needs, even those who are among the most difficult to treat, is an example of how advanced implanted heart device technology has become.”
     
    The Percepta Quad CRT-P features the EffectivCRT Diagnostic, which automatically determines the effectiveness of each left ventricular pace, and the EffectivCRT during AF algorithm, which automatically adjusts pacing rates during atrial fibrillation (AF). It also includes VectorExpress 2.0, an automated in-office test that reduces lead programing to two minutes1, and reveals clinically actionable information to help physicians select optimal pacing configurations for each patient.
     
    The Percepta Quad and Serena Quad CRT-Ps also feature the Medtronic-exclusive AdaptivCRT algorithm, which reduces a patient’s odds of a 30-day heart failure readmission by 59 percent2, and has demonstrated a 46 percent reduction in AF risk compared to echo-optimized biventricular pacing3. Multiple point pacing, which can stimulate the left ventricle (lower chamber) at two sites, is also available on both devices, as well as on the company’s Claria MRI Quad CRT-D SureScan and Amplia MRI Quad CRT-D SureScan.
     
    All three CRT-Ps also are compatible with Attain Performa MRI SureScan Quadripolar Leads, which include short bipolar spacing to reduce the occurrence of phrenic nerve stimulation4, steroid on all electrodes, and three shapes for varying patient anatomies. They also employ the Medtronic-exclusive PhysioCurve contoured design, which reduces overall skin pressure compared to non-contoured devices5, for enhanced patient comfort6 and improved cosmetic appearance of the implant site7. This CRT-P portfolio received CE (Conformité Européenne) mark in February 2017.
     
    “Developing cardiac devices so physicians have the best treatment options to meet the individual needs of their patients is at the core of everything we do,” said David Steinhaus, M.D., vice president and general manager of the Heart Failure business, which is part of the Cardiac and Vascular Group at Medtronic. “With FDA approval of these quadripolar CRT-P devices, we can offer the most innovative pacing technology for improved patient outcomes and enhanced design for their comfort.”
     
    In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world. 

    References
    1 Demmer, W. VectorExpress performance results. Medtronic data on file. January 2013.
    2 Starling RC, Krum H, Bril S, et al. Impact of a Novel Adaptive Optimization Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT Trial. JACC Heart Fail. July 2015;3(7):565-572.
    3 Martin D, et al. Clinical outcomes with adaptive cardiac resynchronization therapy: Long-term
    outcomes of the Adaptive CRT Trial. HFSA Annual Scientific Meeting. September 23, 2013.
    4 Biffi et al. Effort of bipolar electrode spacing on phrenic nerve stimulation and left ventricular pacing thresholds: An acute canine study.Circulation Arrhythmia and Electrophysiology. 2012.
    5 Flo D, et al. IS4/DF4 Device Shape Analysis. Medtronic data on file. January 2013. 
    6 Ceelen KK, et al. J Biomech. 2008;41:3399-3404.
    7 Gold MR, et al. J Am Coll Cardiol. 1996;28;1278-1282.
    Related Searches
    • company
    • data
    • 2015
    • mri
    Related Knowledge Center
    • Cardiovascular
      Loading, Please Wait..

      Trending
      • RJG Names Winners Of 2023 RJG Mold Smart Award
      • Diabetes Innovation: MIT Engineers Unveil Implantable Device With Oxygen Factory
      • A New Approach To Post-Market Surveillance
      • Danaher Names New Environmental And Applied Solutions Company Veralto
      • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
      Breaking News
      • Heather Danks Named Chief Technology Officer at LEX Diagnostics
      • Vitalchat Awarded Patent for Patient Monitoring, Bandwidth Conservation Tech
      • South Korean Regulators Authorize Expanded NeuroStar TMS Indications
      • Ian T. Meredith Joins Avertix Medical’s Board
      • Hologic, Bayer Team Up for Contrast-Enhanced Mammography
      View Breaking News >
      CURRENT ISSUE

      September 2023

      • Superior Subtractive Solutions for Machining Medtech
      • Medical Device Industry Experts' Thought on Assembly & Automation
      • Power Trip: A Discussion of Custom Medical Electronics
      • The MDR Transition: An Opportunity for Design Change?
      • 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

      ABC’s Journal HerbalGram Celebrates 40th Anniversary
      Curcumin May Be As Effective as PPI for Indigestion
      Adding Human Milk Component to Formula Linked to Long-term Cognitive Benefits for Babies
      Coatings World

      Latest Breaking News From Coatings World

      ACC: Let Chemistry Create, so America Can Compete
      WEG Among the Best Companies in Brazil in 2023
      EMPA Develops Flame Resistant Epoxy Resin
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      Heather Danks Named Chief Technology Officer at LEX Diagnostics
      Vitalchat Awarded Patent for Patient Monitoring, Bandwidth Conservation Tech
      South Korean Regulators Authorize Expanded NeuroStar TMS Indications
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Nexcella Completes 2nd NXC-201 Engineering Batch
      Almirall Upgrades Werum PAS-X MES
      Rentschler Names Industry Veterans to Leadership Posts
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      IT Award Winners Announced at MakeUp in NY
      GK Hair Expands Color Range to 125 Hues
      WPO and AIPIA Sign MoU to Collaborate on Smart Packaging
      Happi

      Latest Breaking News From Happi

      Augustinus Bader Introduces Body Cleanser
      Daniel C. Liebler Wins 2023 RIFM Board of Directors Excellence in Science Award
      NAD Refers SBLA Beauty To Federal Trade Commission
      Ink World

      Latest Breaking News From Ink World

      American Chemistry Council (ACC): Let Chemistry Create, so America Can Compete
      HYBRID Software’s PrintFusion for Koenig & Bauer
      Fujifilm Announced European Release of the Acuity Prime Hybrid
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Appvion introduces pre-siliconized Résiste SR
      Vibrant Labelexpo Europe 2023 concludes in Brussels
      Kenco Label & Tag adds sheeting system from Daco Solutions
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Lenzing Earns EU Ecolabel at Indonesian Plant
      Albis Completes Work On Extra Wide Carding, Blending Line
      Ahlstrom Launches Nonwoven Laundry Care Product
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Tyber Nets Several Regulatory Nods for K-Wires, Steinmann Pins
      Relievant Medsystems Releases Medability-Powered Intracept Simulator
      AOFAS, Arthritis Foundation Award Grants to Fuel Ankle Arthritis Research
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      ASSA ABLOY Acquires Forte in Peru
      Le Biscuit Boosts Omnichannel Operations with Zebra Technologies
      German Government, Bavaria Commit Support to ams OSRAM

      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