• 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
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    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
    Top News
    January AI Raises $8.8 Million in New Funding

    FDA Clears Ava Fertility Tracking Wearable Device

    First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System

    Artificial Intelligence, Machine Learning Adoption in Healthcare to Grow Considerably

    Japan to Lead APAC Assisted Reproductive Technology Devices Market
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Rethink Your Medtech ASC Strategy, Part 1

    Pandemic-Level Playing Field: How COVID-19 Made Space for Progress

    Tips for Reigniting Your MDR/IVDR Preparation

    Three Major Innovation Opportunities for Biomedical Textiles

    Use Vertical Integration to Increase Productivity, Drive Innovation
    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
    Forefront Medical Technology

    Concise Engineering

    Qosina Corp.

    Spectrum Plastics Group

    MW Life Sciences
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Refurbished Medical Equipment Testing and Certification Under the NEC

    Taking the First Step with Metal Components

    4 Trends Driving Medical Manufacturing in 2021

    Pioneering AI Solutions to Reinforce Healthcare Services

    The 8 Major Types of PPE Supply Chain Fraud
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Medbio LLC

    PTI Engineered Plastics Inc.

    maxon

    Forefront Medical Technology

    Creganna Medical, part of TE Connectivity
    • 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
    • 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

    Large Japanese Study Finds High Survival Rates With Impella Heart Pump Use

    Data show that Impella therapy is an effective treatment for fulminant myocarditis, with an 88 percent survival rate at 30 days.

    Large Japanese Study Finds High Survival Rates With Impella Heart Pump Use
    Graphic courtesy of Business Wire.
    Related CONTENT
    • FDA Approves Daytime Treatment for Sleep Apnea and Snoring
    • Apple iPhone 12 Magnet Can Deactivate Implantable Cardiac Devices
    • Masimo Releases softFlow High-Flow Nasal Cannula Therapy in U.S.
    • Study Validates Vocalis Health’s COVID-19 Screening Tool
    • RDS Completes 3 Million Euros Seed Funding Round
    Business Wire09.23.20
    A three-year, investigator-led, prospective study of Japanese patients who received an Impella heart pump finds use of Impella is associated with a 77 percent survival rate at 30 days in AMI cardiogenic shock patients. The historic survival rate for cardiogenic shock is approximately 50 percent. The study, conducted with oversight by 10 Japanese professional societies, including the Japanese Circulation Society (JCS), is the first to use the Japanese Registry for Percutaneous Ventricular Assist Devices (J-PVAD) to investigate the efficacy and safety of Impella. J-PVAD data is independently monitored and shared with the Japan Pharmaceuticals and Medical Devices Agency (PMDA). 
     
    The interim analysis examined 819 patients treated with Impella for a variety of conditions, including cardiogenic shock and fulminant myocarditis, at 109 hospitals in Japan. Other findings include that Impella therapy is a highly effective treatment for fulminant myocarditis, with an 88 percent survival rate at 30 days. Overall, investigators conclude the favorable 30-day survival data indicates Impella is a beneficial therapy.
     
    “This data demonstrates early use of Impella in drug-resistant acute heart failure patients can consistently achieve high rates of survival and native heart recovery for those in cardiogenic shock and other serious life-threatening conditions,” said lead investigator Yoshiki Sawa, M.D., Ph.D., a professor at the Department of Cardiovascular Surgery at Osaka University Graduate School of Medicine and president of the Japanese Association of Thoracic Surgery. “This was accomplished by closely following best practices for Impella use. I thank my colleagues in the Japanese clinical community for following protocols and guidance from the Impella Committee to safely introduce a new therapy for the benefit of our patients.”
     
    A previous analysis of cardiogenic shock survival rates in Japan by Ueki et al. (Circulation, 2015), found a 32 percent survival rate at 30 days in patients who received venous-arterial extracorporeal membrane oxygenation (V-A ECMO). The comparatively high survival rates with Impella were achieved by following established best practices that include placing Impella pre-PCI, identifying cardiogenic shock early, using a right heart catheter, and reducing use of inotropes. The study’s findings about the use of best practices are consistent with other published investigator-led studies, such as the National Cardiogenic Shock Initiative Study (NCSI) and the Inova study by Tehrani et al., that have demonstrated significant increases in survival with the use of Impella best practice protocols. 
     
    “This encouraging study demonstrates, when known best practices are followed, significant improvements in cardiogenic shock survival rates can be achieved with use of Impella,” said William O’Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital and principal investigator of the NCSI Study. “I encourage physicians around the world to take note of the Japanese data, which demonstrates the rationale for early use of Impella in cardiogenic shock patients.”
     
    In an online video, Dr. Sawa and Abiomed Chief Medical Officer Chuck Simonton, M.D., discuss how the use of Impella and best practices helped Japanese physicians achieve high survival rates. The video can be viewed here.
     
    Native heart recovery with Impella is a cost-effective therapy of particular importance in Japan, a country with a limited number of heart transplants. The J-PVAD registry study is overseen by the Council for Clinical Use of Ventricular Assist Device Related Academic Societies (Japan VAD Council), Impella Committee, which is comprised of 10 organizations:
     
    • The Japanese Circulation Society (JCS)
    • Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT)
    • Japanese College of Cardiology (JCC)
    • The Japanese Heart Failure Society (JHFS)
    • Japanese Society for Artificial Organs (JSAO)
    • The Japanese Society of Intensive Care Medicine (JSICM)
    • Japanese Society of Pediatric Cardiology and Cardiac Surgery (JSPCCS)
    • The Japanese Association for Thoracic Surgery (JATS)
    • The Japanese Society for Cardiovascular Surgery (JSCVS)
    • Japanese Society of Percutaneous Cardiopulmonary Support / Extracorporeal Membrane Oxygenation (PCPS/ECMO)
     
    The Impella heart pump is manufactured by Abiomed and is the most studied mechanical circulatory support device in the history of the U.S. FDA with more than 14 years of FDA studies, real-world clinical data on more than 125,000 patients, and more than 650 peer-reviewed publications.
     
    The Impella 2.5 and Impella CP devices are FDA PMA-approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to reopen blocked coronary arteries. The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, and Impella 5.5 with SmartAssist 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. The Impella RP is FDA-approved to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant or open-heart surgery. The Impella RP is also authorized for emergency use by healthcare providers (HCPs) in the hospital setting for providing temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥1.5 m2, for the treatment of acute right heart failure or decompensation caused by complications related to coronavirus disease 2019 (COVID‐19), including pulmonary embolism (PE). The Impella RP has not been cleared or approved for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19. The Impella RP has been authorized for the above emergency use by FDA under an EUA and has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
     
    In Japan, the Impella heart pump is used for the following indication: In the treatment of drug-resistant acute heart failure attributable to causes such as cardiogenic shock, a catheter is inserted percutaneously/transvascularly without chest-opening surgery, and blood is aspirated via the tip of a catheter inserted/placed into the left ventricle and pumped out via the outlet port located in the ascending aorta, thereby assisting with antegrade blood circulation in the body. It aims to improve hemodynamics and the recovery of the heart muscles through prompt assistance of antegrade blood flow in a minimally invasive manner while reducing burden on the heart muscles, allowing for prompt recovery of cardiac function.
     
    In Europe, the Impella 2.5, Impella CP and Impella CP with SmartAssist are CE marked for treatment of high-risk PCI and AMI cardiogenic shock patients for up to five days. Impella 5.0 and Impella LD are CE marked to treat heart attack or cardiomyopathy patients in cardiogenic shock for up to 10 days. The Impella 5.5 with SmartAssist is CE marked to treat heart attack or cardiomyopathy patients in cardiogenic shock for up to 30 days. The Impella RP is CE marked to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, open-heart surgery, or refractory ventricular arrhythmia. 
    Related Searches
    • Cardiovascular
    Related Knowledge Center
    • Cardiovascular
    Suggested For You
    FDA Approves Daytime Treatment for Sleep Apnea and Snoring FDA Approves Daytime Treatment for Sleep Apnea and Snoring
    Apple iPhone 12 Magnet Can Deactivate Implantable Cardiac Devices Apple iPhone 12 Magnet Can Deactivate Implantable Cardiac Devices
    Masimo Releases softFlow High-Flow Nasal Cannula Therapy in U.S. Masimo Releases softFlow High-Flow Nasal Cannula Therapy in U.S.
    Study Validates Vocalis Health’s COVID-19 Screening Tool Study Validates Vocalis Health’s COVID-19 Screening Tool
    RDS Completes 3 Million Euros Seed Funding Round RDS Completes 3 Million Euros Seed Funding Round
    Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval
    Rapid Growth Expected for Global Smart Syringe Market Rapid Growth Expected for Global Smart Syringe Market
    Test Identifies COVID-19 Patients at Increased Risk of Intubation With Mechanical Ventilation Test Identifies COVID-19 Patients at Increased Risk of Intubation With Mechanical Ventilation
    Suitcase Laboratory to Detect COVID-19 in Development Suitcase Laboratory to Detect COVID-19 in Development
    SmartBreast Corp. Acquires Discover NM750b from GE Healthcare SmartBreast Corp. Acquires Discover NM750b from GE Healthcare
    Study Links 79 Percent Survival Rate to Impella 5.5 With SmartAssist Study Links 79 Percent Survival Rate to Impella 5.5 With SmartAssist
    FDA Clears Wearable Electrocardiogram Sensor FDA Clears Wearable Electrocardiogram Sensor
    Kardium Receives $115 Million in New Financing for Afib Treatment Kardium Receives $115 Million in New Financing for Afib Treatment
    A Blueprint for Reducing Medtech Industry A Blueprint for Reducing Medtech Industry's Carbon Footprint
    Nēsos Earbud Receives Validation for Treatment of Rheumatoid Arthritis Nēsos Earbud Receives Validation for Treatment of Rheumatoid Arthritis

    Related Breaking News

    • Cardiovascular
      FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump

      FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump

      Puzzle Medical Device's ModulHeart helps patients avoid open-heart surgery and reduces blood trauma.
      Michael Barbella, Managing Editor 02.25.21

    • Cardiovascular
      NTT Research, Japanese Entity to Collaborate on Cardiovascular Disease Interventions

      NTT Research, Japanese Entity to Collaborate on Cardiovascular Disease Interventions

      NCVC in Japan will develop computational models while NTT Research MEI Lab will implement a bio digital twin platform.
      Michael Barbella, Managing Editor 02.24.21

    • Cardiovascular
      RSIP Vision Announces New Coronary Artery Segmentation Tool

      RSIP Vision Announces New Coronary Artery Segmentation Tool

      New module utilizes deep learning algorithms combined with classic computer vision methods to create a 3D model of the coronary arteries.
      Charles Sternberg, Assistant Editor 02.18.21


    • Cardiovascular
      Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval

      Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval

      Technology approved to treat calcified coronary plaque.
      Charles Sternberg, Assistant Editor 02.17.21

    • Cardiovascular
      Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft Systems

      Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft Systems

      Informs physicians to cease use of the device until further notice.
      Charles Sternberg, Assistant Editor 02.17.21

    • Cardiovascular | Neurological
      Cerus Endovascular

      Cerus Endovascular's Contour Neurovascular System Gains Breakthrough Status

      Indicated for the treatment of intracranial aneurysms.
      Sam Brusco, Associate Editor 02.12.21


    • Cardiovascular
      Vascular Perfusion Solutions

      Vascular Perfusion Solutions' VP.S Encore Cardiac Transport Device Wins Breakthrough Status

      Enables preserving of vascularized tissue for eight hours.
      Sam Brusco, Associate Editor 02.09.21

    • Cardiovascular
      Study Links 79 Percent Survival Rate to Impella 5.5 With SmartAssist

      Study Links 79 Percent Survival Rate to Impella 5.5 With SmartAssist

      Data show an 86 percent survival rate for cardiomyopathy cardiogenic shock patients.
      Michael Barbella, Managing Editor 02.08.21

    • Cardiovascular
      FDA Clears Wearable Electrocardiogram Sensor

      FDA Clears Wearable Electrocardiogram Sensor

      The product offers extended ambulatory ECG recording up to three weeks.
      Michael Barbella, Managing Editor 02.08.21


    • Cardiovascular | Surgical
      Edwards Releases 5-Year RESILIA Tissue Aortic Valve Study Data

      Edwards Releases 5-Year RESILIA Tissue Aortic Valve Study Data

      There were no incidences of structural valve deterioration at the five-year mark.
      Sam Brusco, Associate Editor 02.01.21

    • Cardiovascular
      Medtronic Expands Release of Radial Artery Access Portfolio

      Medtronic Expands Release of Radial Artery Access Portfolio

      Completes first-in-patient procedure with newly acquired catheters.
      Charles Sternberg, Assistant Editor 02.01.21

    • Cardiovascular
      Medtronic

      Medtronic's DiamondTemp Ablation System Gains FDA Approval

      Treats patients with recurrent, symptomatic paroxysmal atrial fibrillation unresponsive to drug therapy.
      Sam Brusco, Associate Editor 01.29.21


    • Cardiovascular | Diagnostics
      Philips Introduces Abdominal Aortic Aneurysm 3D Ultrasound

      Philips Introduces Abdominal Aortic Aneurysm 3D Ultrasound

      3D ultrasound integrated with software for breakthrough in surveillance of abdominal aortic aneurysms.
      Sam Brusco, Associate Editor 01.28.21

    • Cardiovascular | Surgical
      Twist on Heart Valve Design Boosts Blood Flow, Prevents Clots

      Twist on Heart Valve Design Boosts Blood Flow, Prevents Clots

      UBC Okanagan research could transform the current gold standard for heart valves.
      Sam Brusco, Associate Editor 01.27.21

    • Cardiovascular
      Alleviant

      Alleviant's Transcatheter Tech Obtains Breakthrough Status

      The technology offers a no-implant interatrial shunt therapy for heart failure patients.
      Sam Brusco, Associate Editor 01.25.21


    Trending
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • FDA Approves Daytime Treatment For Sleep Apnea And Snoring
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • Understanding Food-Grade Vs. Biocompatibility For Medical Device Materials
    Breaking News
    • January AI Raises $8.8 Million in New Funding
    • FDA Clears Ava Fertility Tracking Wearable Device
    • First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    • Artificial Intelligence, Machine Learning Adoption in Healthcare to Grow Considerably
    • Japan to Lead APAC Assisted Reproductive Technology Devices Market
    View Breaking News >
    CURRENT ISSUE

    January/February 2021

    • Seeking a Revolution in Clinical Care Through AI
    • Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit
    • Addition by Subtraction: The Latest of Machining for Medtech
    • Innovation Incubators: An R&D Roundtable
    • Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    • 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

    Preliminary Study Links Markers of Impaired Bone Health to Vegan Diet
    Refined Grains Linked to Heart Attack Risk, Early Death
    Kappa Bioscience Extends Research Partnership For COVID-19 Research
    Coatings World

    Latest Breaking News From Coatings World

    Nippon Paint Marine Wins Korea Export Award
    Universal Display Corporation, PPG Expand Global Production of UniversalPHOLED Materials
    PPG Introduces Premium Iso-free Primer Surfacer, Catalyst
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    January AI Raises $8.8 Million in New Funding
    FDA Clears Ava Fertility Tracking Wearable Device
    First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Spark Therapeutics Appoints CTO
    Cryoport Launches ESG Program
    U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Top Beauty Products of 2021, According to HelloGiggles
    Estée Lauder Taps Ana de Armas as Global Brand Ambassador
    Sephora Announces Significant Expansion
    Happi

    Latest Breaking News From Happi

    ACI Urges Senate to Approve Regan as EPA Administrator
    Estée Lauder Signs Actress Ana de Armas
    GUM Recalls Oral Spray
    Ink World

    Latest Breaking News From Ink World

    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Marshall & Bruce Adds Koenig & Bauer Rapida 106 41-Inch Seven-Color Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    FTA converts Forum & INFOFLEX to virtual events
    Xeikon launches two new digital label printing presses
    UFlex adds capacity in packaging films
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Texas Medical Technology Partners with My Protect Kit
    Mexico City Single-Use Plastics Ban Leads to Tampon Shortage
    Believe Diapers Launch in U.S.
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Fusion Robotics Receives FDA Clearance for Spinal Navigation and Robotics System
    Kaia Health Unveils Next-Gen Complete MSK Care Solutions
    First Implantation of CTL Amedica's Minimally Invasive Flex Tower
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View Research

    Copyright © 2021 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