• 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
    MPO's Most-Read Stories This Week—March 18

    Schurter Launches 5121 Filtered Appliance Inlet

    Suzanne Foster Joins Perimeter Medical Imaging AI Board

    Ra Medical Systems Realigns Its Board of Directors

    Study Backs Tandem Diabetes' Control-IQ 'Artificial Pancreas' in Young Kids
    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
    Arthur G. Russell Co. Inc., The

    LEMO USA Inc.

    Providence Enterprise USA Inc.

    Medbio LLC

    Forefront Medical Technology
    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
    Arthur G. Russell Co. Inc., The

    LEMO USA Inc.

    Providence Enterprise USA Inc.

    Medbio LLC

    Forefront Medical Technology
    • 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 Approves Initiation of STEMI DTU Pivotal Randomized Controlled Trial

    The pivotal trial will be overseen by a steering committee of five expert cardiologists and clinical trialists.

    FDA Approves Initiation of STEMI DTU Pivotal Randomized Controlled Trial
    The STEMI DTU safety and feasibility trial, when compared to the standard of care (reperfusion only) arm of the CRISP AMI trial demonstrates the potential to reduce infarct size in STEMI. Graphic courtesy of Business Wire.
    Business Wire06.17.19
    Abiomed announces U.S. Food and Drug Administration (FDA) approval initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial. The prospective, multi-center, two-arm trial plans to enroll 668 patients undergoing treatment for a STEMI heart attack. Half the patients will be randomized to receive delayed reperfusion after 30 minutes of left ventricular unloading with the Impella CP. The other half will receive immediate reperfusion, the current standard of care.
     
    The trial will test the hypothesis that unloading the left ventricle for 30 minutes prior to reperfusion will reduce myocardial damage from a heart attack and lead to a reduction in future heart failure related events. Myocardial damage can lead to an infarct, and every 5 percent increase in infarct size is associated with a 20 percent increase in relative hazard for all-cause mortality or hospitalization for heart failure within one year after a primary PCI.1 Coronary artery disease is the number one cause of death in the United States. Forty-seven percent of women and 36 percent of men over the age of 45 will die within five years of their first heart attack.2
     
    “The STEMI DTU Pivotal Trial has the potential to improve the standard of care, slow the growing epidemic of heart failure and improve outcomes for millions of heart attack patients. This trial is the first of its kind to focus on ventricular unloading as part of a therapeutic approach for heart attacks without cardiogenic shock and could lead to a paradigm shift in the way heart attack patients are treated worldwide,” said Navin Kapur, M.D., the study’s co-principal investigator and the executive director of the CardioVascular Center for Research and Innovation (CVCRI) at Tufts Medical Center.
     
    Study Summary

    Planned Enrollment:
    • Six hundred sixty-eight subjects, enrolled at up to 60 sites
    • Additionally, the protocol requires each site to “roll-in” two patients (one in each arm) to test the study protocol before beginning enrollment. The trial allows for an adaptive design, which permits adjustments to the study sample size after an interim analysis.
    Expected Timeline:
    • Enrollment begins in October 2019 and is expected to end in three to four years, 2022-2023
    • Six months after enrollment completion: FDA submission for indication approval, based on primary endpoint and safety data analysis
    Endpoints:
    • Primary Endpoint - Infarct size as a percent of left ventricular mass, measured at three to five days using cardiac MRI
    • Key Secondary Effectiveness Endpoint - A composite of the primary endpoint and the following: Cardiogenic shock after 24 hours post enrollment out to 30 days; cardiovascular mortality at 24 months; heart failure requiring hospitalization at 24 months; implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy (CRT) placement at 24 months
    • The trial is powered for multiple other secondary endpoints and has numerous exploratory endpoints, such as infarct size to area at risk
    Projected Budget:
    • $25 million to complete enrollment with an additional two-year follow up to clinical secondary endpoints
    • Reimbursement:
    • Reimbursement for the Impella device is anticipated for patients in the study through CMS category B, as it was during the STEMI DTU safety and feasibility trial
    • A detailed protocol synopsis is available at this link.
     
    The pivotal trial will build on the promising results of the successful STEMI DTU safety and feasibility trial, which met its goal by demonstrating it is safe and feasible to conduct a study of 30 minutes of unloading with delayed reperfusion. The accompanying chart compares the safety and feasibility trial results to the CRISP AMI trial’s standard of care arm (reperfusion only) and demonstrates how 30 minutes of unloading prior to reperfusion has the potential to reduce infarct size in STEMI.
     
    “A successful study will transform the treatment of heart attacks and reduce heart failure for hundreds of thousands of patients each year. As a result, it is important to execute with the highest scientific rigor to ensure a successful study concludes with a Class I recommendation to reach 200,000 U.S. heart attack patients and more than 4 million patients outside the U.S.,” said Michael R. Minogue, chairman, president and CEO of Abiomed.
     
    The pivotal trial will be overseen by a steering committee of five expert cardiologists and clinical trialists. They are: Dr. Kapur, William O’Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital, Jeffrey Moses, M.D., professor of medicine at Columbia University Medical Center and director of interventional cardiovascular therapeutics at Columbia University Medical Center, Gregg Stone, M.D., professor of medicine at Columbia University College of Physicians and Surgeons and director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center, and James Udelson, M.D., chief of the division of cardiology at Tufts Medical Center.
     
    The trial is sponsored by Abiomed. Impella heart pumps are not FDA approved for use in STEMI patients without cardiogenic shock.
     
    The Impella 2.5 and Impella CP devices are FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella LD are FDA approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart.
     
    Impella is the most studied mechanical circulatory support device in the history of the FDA and has exclusive PMA approvals for high-risk PCI, as a therapy to allow for native heart recovery after cardiogenic shock derived from AMI or cardiomyopathy, and right ventricular heart failure.
     
    Based in Danvers, Mass., Abiomed Inc. is a provider of medical devices that provide circulatory support. Its products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart.

    References
    1 Stone, et al., Relationship Between Infarct Size and Outcomes Following Primary PCI, JACC, 2016
    2 Heart Disease and Stroke Statistics 2019 Update: A Report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee." (Circulation. 2019;139(10):56–528).
    Related Searches
    • safety
    • circulatory support
    • therapy
    • mechanical
    Related Knowledge Center
    • Cardiovascular
    Suggested For You
    FDA OKs Neonatal Indication for Masimo FDA OKs Neonatal Indication for Masimo's O3 Regional Oximetry
    FDA OKs ControlRad FDA OKs ControlRad's Radiation Reduction Technology that Integrates into Mobile C-arms
    FDA Approves Device to Help Increase Access to More Lungs for Transplant FDA Approves Device to Help Increase Access to More Lungs for Transplant
    ResMed Unveils Its First Top-of-Head-Connected Nasal Pillows CPAP Mask ResMed Unveils Its First Top-of-Head-Connected Nasal Pillows CPAP Mask
    A New, Tailored Review Framework for Artificial Intelligence-Based Devices A New, Tailored Review Framework for Artificial Intelligence-Based Devices
    EchoNous Releases All-Electronic Bladder Scanning Tool with State-of-the-Art Deep Learning Algorithm EchoNous Releases All-Electronic Bladder Scanning Tool with State-of-the-Art Deep Learning Algorithm
    3M Expands Adhesive Portfolio for Wearable Medical Devices 3M Expands Adhesive Portfolio for Wearable Medical Devices
    FDA to Modernize Mammography Services and Improve Their Quality FDA to Modernize Mammography Services and Improve Their Quality
    FDA OKs Masimo FDA OKs Masimo's Rad-67 Pulse CO-Oximeter
    FDA Warns J&J and Sientra for Breast Implant Compliance Failure FDA Warns J&J and Sientra for Breast Implant Compliance Failure
    FDA to Closely Examine Surgical Stapler Risks FDA to Closely Examine Surgical Stapler Risks
    Abiomed Receives CE Mark for Impella Connect Abiomed Receives CE Mark for Impella Connect
    FDA Commissioner Scott Gottlieb to Step Down FDA Commissioner Scott Gottlieb to Step Down
    ICU Medical Recalls ChemoLock Vial Spike (20mm) Due to Risk of Detached Plastic Particles ICU Medical Recalls ChemoLock Vial Spike (20mm) Due to Risk of Detached Plastic Particles
    FDA Orders Doctor to Cease Marketing Unapproved Breast Augmentation Device FDA Orders Doctor to Cease Marketing Unapproved Breast Augmentation Device

    Related Breaking News

    • Patient Monitoring
      FDA OKs Neonatal Indication for Masimo

      FDA OKs Neonatal Indication for Masimo's O3 Regional Oximetry

      The benefits of monitoring with O3 are now available to patients of all ages, from neonates to adults.
      Business Wire 06.10.19

    • Diagnostics | Patient Monitoring
      FDA OKs ControlRad

      FDA OKs ControlRad's Radiation Reduction Technology that Integrates into Mobile C-arms

      ControlRad Trace is the only technology that can be integrated into existing mobile C-arms to reduce radiation in any fluoroscopic imaging procedure.
      Business Wire 05.23.19

    • Surgical
      FDA Approves Device to Help Increase Access to More Lungs for Transplant

      FDA Approves Device to Help Increase Access to More Lungs for Transplant

      The Xvivo Perfusion System allows the transplant team to perform a more careful assessment of lung function.
      PR Newswire 04.30.19


    • ResMed Unveils Its First Top-of-Head-Connected Nasal Pillows CPAP Mask

      ResMed Unveils Its First Top-of-Head-Connected Nasal Pillows CPAP Mask

      Offers “tube-up” design options for nasal and nasal pillows mask wearers, providing even more flexibility and choice to help users sleep better in any position.
      Business Wire 04.15.19

    • Digital Health | Software & IT
      A New, Tailored Review Framework for Artificial Intelligence-Based Devices

      A New, Tailored Review Framework for Artificial Intelligence-Based Devices

      The FDA is exploring a framework that would allow for modifications to algorithms to be made from real-world learning and adaptation.
      Scott Gottlieb, M.D. , Commissioner, U.S. Food and Drug Administration 04.03.19

    Loading, Please Wait..

    Trending
    • A New Approach To Post-Market Surveillance
    • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    • Philips Names New Supervisory Board Chairman
    • Taiwan Aims To Boost Sales In U.S. Market With New Cost-Saving Medical Devices
    Breaking News
    • Max Novak Joins Trelleborg Healthcare as Project Manager
    • MPO's Most-Read Stories This Week—March 18
    • Schurter Launches 5121 Filtered Appliance Inlet
    • Suzanne Foster Joins Perimeter Medical Imaging AI Board
    • Ra Medical Systems Realigns Its Board of Directors
    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

    'What’s Up With Supps' Event at Expo West Raises Over $8,000 for Vitamin Angels
    IRI and NPD Rebrand as Circana Following Merger
    ABC’s Sustainable Herbs Program Updates Sustainability and Regenerative Practices Toolkit
    Coatings World

    Latest Breaking News From Coatings World

    Miller Paint Partners with Portland Boutique Woonwinkel for 2023 Spring Color Trends
    ALTANA Reports Sales of €3 Billion for First Time in 2022
    Dunn-Edwards Launches New Dead Flat Ceiling Paint
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—March 18
    Schurter Launches 5121 Filtered Appliance Inlet
    Suzanne Foster Joins Perimeter Medical Imaging AI Board
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Enzo Biochem Sells Clinical Laboratory to Labcorp
    53Biologics Expands its State-of-the-art Facilities
    Grand River Aseptic Manufacturing Receives Zero Observations from FDA Inspection
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Weekly Recap: Dove Speaks Out Against TikTok Filter, Living Proof Enters Metaverse & More
    Soapbox Launches New Moisturizing Hand Soaps at Walmart Stores
    Revlon Plans to Emerge from Chapter 11 Bankruptcy in April 2023
    Happi

    Latest Breaking News From Happi

    Fredericksburg Farms Recalls Scented Candles with Glass Lids
    Byoma Enters Suncare with New Moisturizing Gel-Cream SPF 30
    Red Carpet Looks at the Academy Awards and Apollo Buys Univar
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: Energy Curable Inks, Toyo Ink, Resins Top This Week’s Stories
    ALTANA Achieves Sales of €3 Billion for First Time in 2022
    Ball Corporation Releases Climate Transition Plan
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    UPM Raflatac analyzes supply chain, TLMI hosts Converter Meeting and more
    Education sessions announced for Dscoop Edge St. Louis World Expo
    ALTANA reports record sales in 2022
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: TerraCycle Launches Diaper Program, Ahlstrom to Divest or Shutter Stenay Plant & More
    Mativ Names CFO
    Indorama Ventures, Polymateria Partner on Biotransformation Technology
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—March 18
    Accelus' Remi Robotic Navigation OK'ed for GE OEC 9900 C-Arm
    AAOS News: Annunziato (Ned) Amendola Named Second Vice-President
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: LOPEC 2023 Slideshow, Dracula Technologies Top This Week’s Stories
    ALTANA Achieves Sales of €3B for First Time in 2022
    MClimate Releases Maintenance-Free Wireless Thermostat

    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