• 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
    MPO's 2023 Medtech Supply Chain Survey

    Exceeding Medical Device Extrusion Expectations

    Medical Device Micromolders Discuss the 'Minor Details'

    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends
    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
    Zeus Introduces Absorv XSE Oriented Tubing

    Laminate's VasQ Nabs De Novo Nod to Create AVFs for Dialysis Access

    Varian Buys Aspekt Solutions to Bolster Advanced Oncology Biz

    Patient Enrollment Ends in Biosense Webster's SmartfIRE Study

    New Data Shows Advantages of Rapid Medical’s COMANECI Embolization Assist Device
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    MPO's 2023 Medtech Supply Chain Survey

    Exceeding Medical Device Extrusion Expectations

    Medical Device Micromolders Discuss the 'Minor Details'

    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Back to School for Medical Device Cybersecurity Training

    Driving Clinical Trial Excellence to Help Study Teams Run a Faster Relay Race

    Medtech’s Supply Chain: From Disruption to Opportunity

    Are Medtech’s Mega-Deals Gone For Good?

    Will a Skilling Gap Hinder Organizational Readiness for Medtech’s New Age of AI?
    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
    JBC Technologies

    Johari Digital Healthcare Ltd.

    Providence Enterprise USA Inc.

    Halkey-Roberts Corporation

    LEMO USA Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Wearables Are Changing the Way We Collect Real-World Data in Clinical Trials

    Could Medtech Ever Stop a Hospital Killer in Their Tracks?

    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
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    JBC Technologies

    Johari Digital Healthcare Ltd.

    Providence Enterprise USA Inc.

    Halkey-Roberts Corporation

    LEMO 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
    • 2015
    • medtronic plc
    • company
    • surgical
    Related Knowledge Center
    • Cardiovascular
      Loading, Please Wait..

      Trending
      • Cardiosense Begins SEISMIC-HF I Heart Failure Trial
      • Danaher Names New Environmental And Applied Solutions Company Veralto
      • Exo Introduces The Exo Iris To Market
      • A New Approach To Post-Market Surveillance
      • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
      Breaking News
      • 3D Systems Partners with Klarity to Expand Distribution of VSP Bolus Solution
      • Zeus Introduces Absorv XSE Oriented Tubing
      • Laminate's VasQ Nabs De Novo Nod to Create AVFs for Dialysis Access
      • Varian Buys Aspekt Solutions to Bolster Advanced Oncology Biz
      • Patient Enrollment Ends in Biosense Webster's SmartfIRE Study
      View Breaking News >
      CURRENT ISSUE

      October 2023

      • MPO's 2023 Medtech Supply Chain Survey
      • Exceeding Medical Device Extrusion Expectations
      • Medical Device Micromolders Discuss the 'Minor Details'
      • 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

      PLT Health Solutions Granted Claims for Botanical Ingredient in Canada
      CRN Files Petition with FTC For Clarity on Health Products Compliance Guidance
      Vitafoods Europe Relocates to Barcelona Starting 2025
      Coatings World

      Latest Breaking News From Coatings World

      U.S. Green Building Council and RMI Release Report to Drive Action on Embodied Carbon in Buildings
      Tim Knavish Elected PPG Chairman and CEO
      Alabama Students Gain Real-World Experience with Internships at BASF
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      Zeus Introduces Absorv XSE Oriented Tubing
      Laminate's VasQ Nabs De Novo Nod to Create AVFs for Dialysis Access
      Varian Buys Aspekt Solutions to Bolster Advanced Oncology Biz
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Ginkgo Bioworks, Pfizer Enter Multi-Target RNA Discovery Alliance
      Flexan, Dover Earn Class 7 Certification for Cleanroom in Mexico
      Everads, Kriya Partner on Ocular Gene Therapy Candidates
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      BASF and StitchCrew Introduce Educational Bootcamp for Indigenous Beauty Brands
      Top 10 Most Popular Fashion Designer Makeup Brands—According to Landys Chemist
      Jennifer Coolidge Collaborates with e.l.f. Cosmetics for 'Dirty Pillows' Lip Collection
      Happi

      Latest Breaking News From Happi

      Victoria Beckham Beauty to Make Fragrance Debut with Unisex Scent Trio
      Bio-Oil Launches 'Labor of Love' Campaign
      Wharton To Honor Leonard A. Lauder with Retail Excellence Award
      Ink World

      Latest Breaking News From Ink World

      Sapphire Ink – SB Eco Series Receives Oeko-Tex Eco Passport ZDHC Level 3 Certification
      Flint Group Digital with Xeikon Present at FEFCO Technical Seminar
      R.E. Carroll Inc. Packs, Donates 400 Backpacks to Students
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Schreiner MediPharm introduces Freeze-Light-Protect syringe label
      Kodak launches PRINERGY 10.0
      UPM Raflatac receives new approval for linerless label printing
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Ana Fraisse Joins The American Cleaning Institute
      Weekly Recap: Soft N' Dry Seeks to Expand Private Label Roll Out, Albis Completes Work on Line
      Lenzing Earns EU Ecolabel at Indonesian Plant
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Intech Acquires Lenkbar LLC
      ONWARD Completes First-in-Human for ARC-IM to Restore Upper Extremity Function
      Michael S. Aronow Installed as AOFAS President
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      PPG and Flō-Optics Enter Exclusive Supplier Agreement
      SEMI North America Advisory Board Adds New Members
      Nhat Tin Logistics Enhances Operations with Zebra Technologies

      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