• 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
    Optimize EP Launches CaRM Cardiac Device Data Management Platform

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

    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR

    Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

    Moon Surgical Expands Leadership Team
    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
    Medicoil

    Qosina Corp.

    Concise Engineering

    FUTEK Advanced Sensor Technology Inc.

    K-Tube Technologies
    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
    Unicep

    PTI Engineered Plastics Inc.

    Medicoil

    MW Life Sciences

    Element
    • 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
    Top30

    23. Edwards Lifesciences Corp.

    ...

    23. Edwards Lifesciences Corp.
    Related CONTENT
    • Edwards Treats First Patient in Restore Clinical Trial
    • LivaNova to Sell Heart Valve Biz to Gyrus Capital for $73M
    • Foldax Strengthens its Scientific and Medical Advisory Boards
    • Medtronic, The Foundry to Develop Mitral Valve Repair Technology
    • Medtronic Begins TAVR Study Comparing Evolut Against Edwards' Sapien Valve
    07.26.18
    $3.4 Billion

    KEY EXECUTIVES:
    Michael A. Mussallem, Chairman and CEO
    Daveen Chopra, Corp. VP, Surgical Heart Valve Therapies
    John P. McGrath, Ph.D., Corp. VP, Quality, Regulatory, Clinical
    Joseph Nuzzolese, Corp. VP, Global Supply Chain
    Stanton J. Rowe, Corp. VP, Advanced Technology and Chief Scientific Officer
    Catherine M. Szyman, Corp. VP, Critical Care
    Scott B. Ullem, Corp. VP, CFO
    Larry L. Wood, Corp. VP, Transcatheter Heart Valves
    Bernard J. Zovighian, Corp. VP, Transcatheter Mitral and Tricuspid Therapies

    NO. OF EMPLOYEES: 12,200

    GLOBAL HEADQUARTERS: Irvine, Calif.

    Even at 66 years of age, James Garrett led a very active lifestyle. His passion for rock climbing resulted in him being credited with more than 300 “first ascents,” pioneering climbing routes all over the world. In his travels as a flight nurse, he also witnessed many medical needs in developing countries. One that particularly interested him was the battle against cataracts. He began volunteering with the Himalayan Cataract Project where he mentors and works with local paramedical staff during high-volume cataract surgery campaigns to help restore sight to those with little access to eye care around the world.

    On an average evening in 2017, while on the couch with his physician wife, all of that came to a sudden and frightening halt.

    “I had my head and my ear against his chest,” said James’ wife, Franziska Garrett, M.D. She then sprang up suddenly and exclaimed that she heard a really loud murmur. She continued, “We knew we had to see a cardiologist right away. I was definitely shocked.”

    The cardiologist noted James’ aortic valve was a congenitally malformed bicuspid valve, diagnosed him with aortic stenosis, and asked with urgency how soon could they schedule James for open-heart surgery.

    As would be understandable, James wasn’t on board with the prospect of open-heart surgery.

    Oddly fortunate, during one of his trips, James contracted a viral respiratory illness that created questions about the safety of performing an open-heart procedure on him. As a result, James Harkness, M.D., interventional cardiologist and Stephen Clayson, M.D., cardiothoracic surgeon, both of Intermountain Medical Center Heart Institute in Salt Lake City, Utah, began to explore other treatment options. TAVR (transcatheter aortic valve replacement) was selected as the best alternative for him. The Edwards SAPIEN 3 transcather heart valve was the specifically chosen solution.

    As a result of the TAVR technique, physicians were able to perform the procedure with James under conscious sedation, meaning he would not be under general anesthesia, which was important given his respiratory condition.

    A few weeks after placement of the replacement valve, James felt like “himself” again and his lungs were healing as well. He has continued his work in the fight against cataracts in regions around the world and he and his wife are very grateful to be able to do so.

    Unfortunately, the health battle patients like James face requiring the placement of a TAVR device isn’t the only fight Edwards has been associated with involving the technology. In 2017, the company faced ongoing legal challenges regarding the validity of several patents in a dispute with Boston Scientific.

    In March 2017, a U.K. patent court and a German patent court both issued initial decisions that stated one of Boston Scientific’s patents asserted against Edwards’ patent was invalid while another was deemed valid and infringed. A year later, the European Patent Office sided with Boston Scientific, along with several other opponents, in its dispute of Edwards Lifesciences’ European patent EP 2,399,550, which resulted in a revocation of the patent. This action harkened back to the German court decision, which found Boston Scientific infringed upon that patent. The patent dispute is ongoing.

    Meanwhile, in the United States in March 2018, the U.S. Patent and Trademark Office decided in Edwards’ favor in an Inter Partes Review of Boston Scientific’s U.S. transcatheter heart valve patent, number 8,992,608. All claims of the ‘608 patent asserted against Edwards were determined to be invalid. Similar to the European case, the U.S. dispute is ongoing as well.

    As can be observed in the anecdotal story involving James Garrett, TAVR represents a new, novel therapeutic approach to treat a damaged heart valve. As such, it’s no surprise to see medtech companies fight over the rights to the patents involved with the technology. It could result in a significant reward for the “winner” in licensing agreements and/or market share.

    Certainly, Edwards is well aware of the potential of the technology. The company already saw an impressive 16 percent increase in 2017’s net sales ($3.4 billion) over 2016’s just-shy $3 billion total. Further, the company has enjoyed steady growth since at least 2013 when it posted $2 billion in sales, but noted in its 2017 annual report it has experienced 10 years of double-digit adjusted sales growth. With a focus on cardiovascular disease, the company approaches its treatment options for healthcare by way of three separate divisions—Transcatheter Heart Valve Therapy, Surgical Heart Valve Therapy, and Critical Care.

    The Transcatheter Heart Valve Therapy unit is helmed by two major products for Edwards, the SAPIEN XT and SAPIEN 3 transcatheter aortic heart valves and their respective delivery systems. The segment contributes a majority number to the company’s sales total, delivering 59 percent in 2017 (a significant increase compared to 47 percent just two years prior). That translates to just over $2 billion in 2017 net sales—an almost 25 percent increase over 2016, which had experienced a 38 percent rise over its prior year.

    The next largest unit in net sales in 2017 was Surgical Heart Valve Therapy. This unit’s signature product is the Carpentier-Edwards PERIMOUNT pericardial valve platform, including the line of PERIMOUNT Magna Ease pericardial valves for aortic and mitral surgical valve replacement. Contributing $807 million in 2017, the segment enjoyed a 4.2 percent increase over the prior year, which was a welcome change for the company compared to its 2016 total when the unit’s sales shrank 1.3 percent from 2015.

    Accounting for the remainder is Critical Care, comprised of hemodynamic monitoring systems used to measure a patient’s heart function and fluid status in surgical and intensive care settings. Edwards offers a selection of products for this space, including the minimally invasive FloTrac system and the noninvasive ClearSight system. It saw sales of $601 million in 2017, which was a bump up from 2016 by 7.3 percent.

    Edward’s biggest market is the United States, where it achieved sales of more than 1.9 billion in fiscal 2017. Internationally, it took in $1.5 billion, with Europe ($831 million) and Japan ($350 million) reflecting the lion’s share of that total.

    Not satisfied to rest on its laurels as it looks to the future, Edwards made two complementary acquisitions in 2017 to help ensure its growth remains positive. In the first month of its 2017 fiscal year, Edwards completed a previously announced purchase. In November 2016, the firm revealed it would be buying Valtech Cardio Ltd. for $340 million, with the potential for up to $350 million in pre-specified milestone driven payments over the next 10 years. The Israeli firm developed the Cardioband system, which is used for transcatheter repair of the mitral and tricuspid valves.

    “We look forward to the Valtech team joining Edwards. We believe their knowledge, experience, and the Cardioband technology are valuable additions to Edwards,” Michael A. Mussallem, Edwards’ chairman and CEO, said in a news release declaring the close of the transaction. “This therapy has the potential to be a breakthrough structural heart therapy to help many patients in desperate need, and we look forward to gaining valuable insights from its commercial use in Europe.”

    The device still awaits FDA clearance in the United States.

    Bookending the fiscal year with the Valtech acquisition, Edwards announced the December 1 closing of its acquisition of Harpoon Medical on December 6. Harpoon’s focus was on the development of technology to enable beating-heart repair for degenerative mitral regurgitation. The purchase price was $100 million in cash at the close, with the potential for an additional $150 million if certain milestones are met within the following 10 years. According to Edwards, the system is designed to facilitate echo-guided repair of mitral valve regurgitation by stabilizing the prolapsed mitral valve leaflet to restore proper coaptation and valve function.

    Regarding the acquisition of Harpoon, Bernard Zovighian, Edwards’ then corporate vice president of surgical heart valve therapy, said, “The unique beating-heart repair procedure for mitral valve patients complements Edwards’ comprehensive portfolio of treatments for structural heart disease, and reinforces our commitment to innovation in cardiac surgery.”
    Related Searches
    • surgical
    • acquisition
    • led
    • eye
    Suggested For You
    Edwards Treats First Patient in Restore Clinical Trial Edwards Treats First Patient in Restore Clinical Trial
    LivaNova to Sell Heart Valve Biz to Gyrus Capital for $73M LivaNova to Sell Heart Valve Biz to Gyrus Capital for $73M
    Foldax Strengthens its Scientific and Medical Advisory Boards Foldax Strengthens its Scientific and Medical Advisory Boards
    Medtronic, The Foundry to Develop Mitral Valve Repair Technology Medtronic, The Foundry to Develop Mitral Valve Repair Technology
    Medtronic Begins TAVR Study Comparing Evolut Against Edwards Medtronic Begins TAVR Study Comparing Evolut Against Edwards' Sapien Valve
    10. Baxter International 10. Baxter International
    Selling Regulatory Compliance Selling Regulatory Compliance
    Boston Scientific Recommends Stockholders Reject Boston Scientific Recommends Stockholders Reject 'Mini-Tender' Offer by TRC Capital
    Boston Scientific Launches HeartLogic Heart Failure Diagnostic in Europe Boston Scientific Launches HeartLogic Heart Failure Diagnostic in Europe
    Boston Scientific Responds to Boston Scientific Responds to '60 Minutes' Transvaginal Mesh Report
    Boston Scientific Closes NxThera Acquisition Boston Scientific Closes NxThera Acquisition
    Positive Late-Breaking Data Unveiled for Boston Scientific Positive Late-Breaking Data Unveiled for Boston Scientific's Deep Brain Stimulation Study
    Boston Scientific Prevails In European Patent Dispute With Edwards Boston Scientific Prevails In European Patent Dispute With Edwards
    Boston Scientific Acquires nVision Medical for Up to $275M Boston Scientific Acquires nVision Medical for Up to $275M
    Planning for Brexit Planning for Brexit

    Related Top30

    • The 2020 Top 30 Global Medical Device Companies

      The 2020 Top 30 Global Medical Device Companies

      Leadership changes, divestments, and portfolio-building partnerships—through acquisition or collaboration—were common threads among medtech’s largest players.
      MPO Editors 07.21.20

    • The 2019 Top 30 Global Medical Device Companies

      The 2019 Top 30 Global Medical Device Companies

      ...
      Sean Fenske, Michael Barbella, & Sam Brusco, MPO Editorial Staff 07.30.19

    • 1. Medtronic

      1. Medtronic

      ...
      07.30.19


    • 2. Johnson & Johnson

      2. Johnson & Johnson

      ...
      07.30.19

    • 3. GE Healthcare

      3. GE Healthcare

      ...
      07.30.19

    • 4. Abbott

      4. Abbott

      ...
      07.30.19


    • 5. Philips

      5. Philips

      ...
      07.30.19

    • 6. BD

      6. BD

      ...
      07.30.19

    • 7. Cardinal Health

      7. Cardinal Health

      ...
      07.30.19


    • 7. Siemens Healthineers

      7. Siemens Healthineers

      ...
      07.30.19

    • 9. Stryker

      9. Stryker

      ...
      07.30.19

    • 10. Baxter

      10. Baxter

      ...
      07.30.19


    • 11. Boston Scientific

      11. Boston Scientific

      ...
      07.30.19

    • 12. Danaher

      12. Danaher

      ...
      07.30.19

    • 13. EssilorLuxottica

      13. EssilorLuxottica

      ...
      07.30.19


    Trending
    • STERIS To Buy Cantel Medical For $4.6B
    • Meeting Critical Ventilator Product Requirements Amid Pandemic
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Medtech Matters: Talking Robotic Surgery With Zimmer Biomet
    Breaking News
    • Optimize EP Launches CaRM Cardiac Device Data Management Platform
    • U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    • FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    • Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation
    • Moon Surgical Expands Leadership Team
    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

    Brown Fat Associated with Reductions in Chronic Disease Risk
    NIH Study Identifies Antibacterial Properties in Taurine
    NSF Begins New Certification Program
    Coatings World

    Latest Breaking News From Coatings World

    Zeppelin Acquires MTI Mischtechnik
    Ezio Braggio Joins ChemQuest Europe
    IFS Coatings Announce Carbon Offset Program
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Optimize EP Launches CaRM Cardiac Device Data Management Platform
    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    Contract Pharma

    Latest Breaking News From Contract Pharma

    KORSCH, MEDELPHARM Partner on R&D Equipment Portfolio
    Frontage Bolsters Clinical Services Capabilities
    Sanofi Unveils EUROAPI as Name of New European API Company
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Neenah to Host Packaging Webinar for Printers
    W.S. Badger is Named a ‘150 Top Impact Company’
    Mana Products, Meiyume and RPG Form The Vertical Beauty Alliance
    Happi

    Latest Breaking News From Happi

    Amyris Named a Top Social & Environmental Impact Company
    L'Oréal Bans Animal Hair in Brushes
    Ashland Launches Antaron ECo Gel
    Ink World

    Latest Breaking News From Ink World

    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Techkon USA, Konica Minolta Partner
    Alon Bar-Shany Appointed Chairman of Highcon Board
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Exhibitor registration opens for virtual.drupa
    FTA planning in-person Forum & INFOFLEX
    Fortis Solutions Group achieves SGP certification
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Shemesh Adds U.S. Headquarters
    TZMO USA, Special Needs Group Form Partnership
    BAHP Announces 2021 Officers, Board of Directors
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Rapid Recovery Protocol Can Lead to Increased Range of Motion After TKA
    Boston Scientific Releases WaveWriter Alpha Spinal Cord Stimulators in U.S.
    New Chief Clinical Officer on Board at IncludeHealth
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Toppan Announces 2050 Environmental Vision
    SOI Industry Consortium Joins SEMI as Strategic Association Partner

    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