• 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
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    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
    Alleviant's Transcatheter Tech Obtains Breakthrough Status

    Signia Appoints New President

    At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities

    QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner

    MedAcuity, Fathom Partner on Human Factors Engineering Services
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    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
    Unicep

    Medicoil

    K-Tube Technologies

    Element

    Creganna Medical, part of TE Connectivity
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Concise Engineering

    Element

    K-Tube Technologies

    MW Life Sciences

    Medicoil
    • 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

    FDA Approves Abiomed's Minimally Invasive, Forward Flow Heart Pump

    Impella 5.5 with SmartAssist can help stabilize a patient after cardiac decompensation and give the heart time to rest and recover.

    FDA Approves Abiomed
    Impella 5.5 with SmartAssist delivers peak flows of greater than 6 liters per minute. A motor housing that is thinner and 45 percent shorter than the Impella 5.0 improves ease of pump insertion through the vasculature. Image courtesy of Business Wire.
    Related CONTENT
    • Large Japanese Study Finds High Survival Rates With Impella Heart Pump Use
    • Studies Show Feasibility of a Minimally Invasive Approach to CGM in the Dermis
    • Abbott Vascular Executive Assumes Chief Medical Officer Role at Abiomed
    • Abiomed's Impella Heart Pump Gains EUA for Unloading Therapy for COVID-19 Patients
    • FDA Approves Data Streaming from Abiomed's Impella Console
    Business Wire09.26.19
    Abiomed’s newest heart pump, the Impella 5.5 with SmartAssist, has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days.
     
    Impella 5.5 with SmartAssist is:
     
    • Minimally invasive, eliminating the need for a sternotomy or coring of the left ventricle
    • Designed for heart surgeons, implanted via the axillary artery or the anterior aorta
    • Forward flow, to provide the patient with coronary flow and renal perfusion
    • Fully unloading, to reduce the heart’s oxygen demand and work
    • Equipped with SmartAssist, designed to provide weaning algorithms to optimize survival and native heart recovery
     
    “A minimally invasive, forward flow, fully unloading heart pump that is designed for surgery is game changing,” said Mark Anderson, M.D., chief of the Division of Cardiac Surgery and cardiothoracic surgeon at the Heart and Vascular Hospital at Hackensack University Medical Center and Hackensack Meridian Health. “This gives cardiac surgeons a new and potentially better option that can provide the benefits of heart recovery to some of our sickest patients.”
     
    “The Impella 5.5 is designed to give severely ill patients the best chance for recovery of the heart," said Hermann Reichenspurner, MD, PhD, professor and chief, Department of Cardiovascular Surgery, University Heart Center Hamburg. "A forward flow, minimally invasive heart pump that unloads the left ventricle and perfuses the end organs adequately is an ideal tool to help stabilize a patient after cardiac decompensation and give the heart time to rest and recover."
     
    The FDA indication for use of Impella 5.5 with SmartAssist is as follows:
     
    The Impella 5.5 with SmartAssist System is a temporary ventricular support device intended for short term (14 days) use and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP). The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.
     
    Impella 5.5 with SmartAssist delivers peak flows of greater than 6 liters per minute. A motor housing that is thinner and 45 percent shorter than the Impella 5.0 improves ease of pump insertion through the vasculature.
     
    The inclusion of SmartAssist enables intelligent decision making with weaning algorithms designed to increase survival with heart recovery. SmartAssist also integrates data informatics including left ventricular pressure (LVP), end-diastolic pressure (EDP) and cardiac power output (CPO). The SmartAssist fiberoptic pressure sensor allows for precise pump positioning, management and repositioning in the ICU. Impella Connect enables clinicians to view the Impella control screen through a secure, HIPAA compliant website to track and review cases at any time from any internet-connected device.
     
    The Impella 5.5 with SmartAssist will be introduced in the United States through a controlled rollout at hospitals with established heart recovery protocols. Impella 5.5 with SmartAssist received CE marking approval in Europe in April 2018 and was introduced in Germany through a similar controlled rollout.
     
    The supplement approval for the Impella 5.5 with SmartAssist stems from the FDA’s Impella PMA approvals indicating Impella devices as safe and effective for the treatment of cardiogenic shock. The approvals were based on analyses of Impella clinical results in 508 patients, which includes the FDA study RECOVER I, and the U.S. Impella registry, and of Impella literature reviews of 801 patients in 33 clinical studies. Additionally, more than 49,000 patients supported by Impella technology were reviewed in a safety analysis.
    Related Searches
    • devices
    • impella
    • patient
    • data
    Related Knowledge Center
    • Cardiovascular
    • Surgical
    Suggested For You
    Large Japanese Study Finds High Survival Rates With Impella Heart Pump Use Large Japanese Study Finds High Survival Rates With Impella Heart Pump Use
    Studies Show Feasibility of a Minimally Invasive Approach to CGM in the Dermis Studies Show Feasibility of a Minimally Invasive Approach to CGM in the Dermis
    Abbott Vascular Executive Assumes Chief Medical Officer Role at Abiomed Abbott Vascular Executive Assumes Chief Medical Officer Role at Abiomed
    Abiomed Abiomed's Impella Heart Pump Gains EUA for Unloading Therapy for COVID-19 Patients
    FDA Approves Data Streaming from Abiomed FDA Approves Data Streaming from Abiomed's Impella Console
    Abiomed Expands Product Portfolio with Breethe Purchase Abiomed Expands Product Portfolio with Breethe Purchase
    Minerva Surgical Acquires Boston Scientific Intrauterine Health Products Minerva Surgical Acquires Boston Scientific Intrauterine Health Products
    GlobalData: Medtronic’s MI Business to Exhibit Slow Growth GlobalData: Medtronic’s MI Business to Exhibit Slow Growth
    VisCardia VisCardia's Heart Failure Therapy Gains Breakthrough Designation
    Medtronic Sees Revenue Losses Due to COVID-19 Pandemic Medtronic Sees Revenue Losses Due to COVID-19 Pandemic
    Medtronic Shares Ventilator Design Specifications Medtronic Shares Ventilator Design Specifications
    FDA Encourages Patient Engagement in Medical Device Clinical Investigations FDA Encourages Patient Engagement in Medical Device Clinical Investigations
    FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k) FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k)
    OS-SiA, a Next-Gen AI-Enabled Digital Scanner, is Launched by OptraSCAN OS-SiA, a Next-Gen AI-Enabled Digital Scanner, is Launched by OptraSCAN
    FDA Advises Transition to Disposable Duodenoscopes FDA Advises Transition to Disposable Duodenoscopes

    Related Breaking News

    • 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

    • Cardiovascular
      First Heart Failure Patient Treated With Impulse Dynamics

      First Heart Failure Patient Treated With Impulse Dynamics' CCM Therapy in Brazil

      The Optimizer delivers cardiac contractility modulation therapy, the company’s proprietary technology, to the heart.
      Business Wire 01.21.21

    • Cardiovascular
      Boston Scientific to Acquire Preventice for Up to $925M

      Boston Scientific to Acquire Preventice for Up to $925M

      Acquisition of external cardiac monitoring technologies, services provider to expand rhythm management diagnostics portfolio.
      PR Newswire 01.21.21


    • Cardiovascular | Surgical
      Haemonetics to Acquire Cardiva for Up to $510M

      Haemonetics to Acquire Cardiva for Up to $510M

      Enhances penetration into the large and growing interventional cardiology and electrophysiology markets.
      PR Newswire 01.20.21

    • Cardiovascular | Surgical
      Abbott Wins Expanded Medicare Coverage for MitraClip

      Abbott Wins Expanded Medicare Coverage for MitraClip

      Includes patients with secondary (or functional) mitral regurgitation resulting from heart failure.
      Abbott Laboratories 01.20.21

    • Surgical
      Freehand Partners with Imperial Medical Solutions

      Freehand Partners with Imperial Medical Solutions

      Supports the introduction of its surgical robots in India, Sri Lanka, Malaysia and the Caribbean.
      Freehand 01.19.21


    • Cardiovascular | Patient Monitoring
      Hillrom to Buy Bardy Diagnostics for $375M

      Hillrom to Buy Bardy Diagnostics for $375M

      Advances digital health offering with expansion into attractive ambulatory cardiac monitoring segment.
      PR Newswire 01.19.21

    • Cardiovascular
      Occlutech

      Occlutech's Atrial Flow Regulator Earns Breakthrough Status for HF

      First-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients.
      PR Newswire 01.19.21

    • Cardiovascular | Diagnostics
      FDA OKs MRI for Impulse Dynamics

      FDA OKs MRI for Impulse Dynamics' Optimizer CCM Delivery Systems

      FDA clears potential hurdle for many heart failure patients.
      Business Wire 01.19.21


    • Surgical
      TransEnterix Wins EU Approval for Robotic Surgical Machine Vision System

      TransEnterix Wins EU Approval for Robotic Surgical Machine Vision System

      Intelligent Surgical Unit enables augmented intelligence on the Senhance surgical system.
      Business Wire 01.19.21

    • Cardiovascular
      FineHeart Successfully Tests Wireless TET System

      FineHeart Successfully Tests Wireless TET System

      A breakthrough in treating patients with severe heart failure.
      FineHeart 01.18.21

    • Cardiovascular
      U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

      U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

      The use of TAVR over open surgical techniques for replacing an aortic valve has exploded globally in recent years.
      GlobalData 01.15.21


    • Surgical
      Moon Surgical Expands Leadership Team

      Moon Surgical Expands Leadership Team

      Adds Jeffery Alvarez, David Noonan, and Nicolas Linard.
      Moon Surgical 01.14.21

    • Cardiovascular
      WhiteSwell Issued Patent for Treatment of Acute Decompensated Heart Failure

      WhiteSwell Issued Patent for Treatment of Acute Decompensated Heart Failure

      Company adds to portfolio of 40 patents for catheter-based technology that leverages the power of the body’s natural fluid removal process.
      Business Wire 01.13.21

    • Neurological | Surgical
      FDA OKs ClearMind Biomedical

      FDA OKs ClearMind Biomedical's Axonpen Neuroendoscope

      Requires only a narrow channel of 6.5mm through the skull for insertion into the brain.
      PR Newswire 01.12.21


    Trending
    • Senseonics Forges Strategic Collaboration With Ascensia Diabetes Care
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Top 10 Trends In The Medical Device And Equipment Industry
    • Masimo Earns CE Mark For New Fingertip Pulse Oximeter
    • At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    Breaking News
    • Alleviant's Transcatheter Tech Obtains Breakthrough Status
    • Signia Appoints New President
    • At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    • QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner
    • MedAcuity, Fathom Partner on Human Factors Engineering Services
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • 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

    Clinical Evidence Suggests Potential Oral Benefits for Curcumin Extract
    Oleic Acid Possibly Implicated in MS Pathology
    NIH Study Compares Low-Fat, Plant-Based to Low-Carb, Animal-Based Diet
    Coatings World

    Latest Breaking News From Coatings World

    APV Engineered Coatings Reflects on 2020
    LINE-X Launches Dealer Program with International Truck
    BCF CEO to Chair Royal Society of Chemistry Surface Coatings Interest Group
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Alleviant's Transcatheter Tech Obtains Breakthrough Status
    Signia Appoints New President
    At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Civica to Build an Essential Medicines Manufacturing Facility in Virginia
    Humanigen, Emergent Enter Covid-19 Partnership
    Samsung Bioepis Opens New Headquarters
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Fitglow Beauty Wins Big at Annual Dirty Thinker’s Choice Awards
    e.l.f. Cosmetics Unveils Mint Melt Collection
    Estée Lauder Companies Updates Supply Chain Leadership
    Happi

    Latest Breaking News From Happi

    Some Good News at Inter Parfums
    Professional Beauty Association Names New Executive Director
    Curcumin's Role in Oral Care
    Ink World

    Latest Breaking News From Ink World

    Paragon Expands Direct Mail Capabilities with Ricoh Pro VC70000
    BOBST Demonstrates Future of Flexible Packaging Production at Virtual Open House
    Morancé Soudure France Adds Comexi F2 MC 10-color Flexo Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    VPF launches deep-freeze adhesive
    ProMach strengthens flexible packaging business
    Gallus planning virtual event for March
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Kimberly-Clark Releases Q4, Full Year Results
    Freudenberg to Establish Apparel Interlining Competence Centers
    Minet Adds Spunlace Line in Romania
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    First Patient Implanted With NEXXT MATRIXX SA Cervical Turn-Lock System
    Cretex Companies CEO Steps Down
    Conformis Enters Development & Supply Agreement with SITES Medical
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    First Solar Signs Definitive Agreement to Sell US Development Platform to Leeward
    Imec Technology Taking Off to Space
    North American Semiconductor Equipment Industry Posts December 2020 Billings

    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