• 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
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    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
    EchoNous Partners with Samsung

    Solid Growth Forecast for Global Ostomy Devices Market

    KA Imaging's Reveal 35C Images Increase Lung Lesion Visibility

    Respira Technologies Appoints Brian Quigley as CEO

    Nikki Troiano Gainey Joins RIVANNA Board
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Cooling and Melting the Pain Away

    What Are the Fundamentals of Go-To-Market Strategy in Medical Devices?

    Minding the Gap: How Harmonizing Quality Systems Pays Off

    Building Strong Partnerships Between Medtech and Surgeon-Learning Platforms

    Four Key Considerations for OEMs Transferring a Product Program
    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

    Concise Engineering

    Trademark Plastics Inc.

    Cirtec Medical

    Arthur G. Russell Co. Inc., The
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Buyer and Seller Tips on Mergers & Acquisitions for MPO Companies

    Medical Computing: COM Express Processes Real-Time Data at the Edge

    The Importance of Building Successful Supplier Relationships

    The Benefits of Outsourcing Innovation in Medtech Manufacturing

    Patching Healthcare Cybersecurity Risks in the Internet of Medical Things
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    JBC Technologies

    Concise Engineering

    Trademark Plastics Inc.

    Cirtec Medical

    Arthur G. Russell Co. Inc., The
    • 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
    Columns

    15 Years of Consi-stent Medtech Progress

    ...

    Related CONTENT
    • FDA Initiates Device Development Challenge to Help Combat Opioid Crisis
    • Boston Scientific Launches HeartLogic Heart Failure Diagnostic in Europe
    • FDA Approves Abbott's Xience Sierra Everolimus-Eluting Coronary Stent
    • 3 Critical Considerations for U.S. Medical Device Commercialization
    • Boston Scientific Responds to '60 Minutes' Transvaginal Mesh Report
    Sam Brusco, Associate Editor06.04.18
    Though merely 15 years ago, given the breakneck pace of innovation these days, 2003 seems a world away in terms of science and technology. It was the year the Concorde supersonic jet made its final flight; the year Kodak released the first digital camera with an organic light-emitting diode (OLED) display; and the year the National Human Genome Research Institute and the Department of Energy unveiled the successfully completed Human Genome Project, the culmination of a 13-year effort to sequence the three billion DNA letters in the human genome.

    2003 also marked Medical Product Outsourcing’s flagship issue, featuring the very first Top 30 Global Medical Device Companies report (this year’s version to be featured next month—stay tuned).

    That year’s list of the elite was championed by global medical device, drug, and consumer products company Johnson & Johnson, which would remain at the top spot for over a decade. J&J’s $11.6 billion in medical device revenue now seems paltry compared to 2017’s leader—Medtronic plc—which touted $28.8 billion in sales.

    Partially responsible for J&J’s windfall in 2003 resulted from Cordis Corporation’s (then a J&J business, now owned by Cardinal Health) April launch of a landmark treatment for coronary artery disease, and the first commercial device of its type—the Cypher drug-eluting stent, or DES for short.

    Cordis’ Cypher DES was hailed as the first combination drug-device intended to help reduce restenosis (blockage) of a coronary artery treated with a stent. Restenosis was then—and continues to be—an enormous challenge in long-term stent implantations used for interventional cardiology treatment. To prevent it, Cypher was coated in sirolimus, a macrolide compound that is also used to prevent organ transplant rejection and treat LAM—a rare, progressive, and systemic lung disease.

    “Cordis is very pleased to bring this remarkable and innovative treatment to patients, hospitals, and interventional cardiologists,” said then Johnson & Johnson Company Group Chairman Robert Croce upon Cypher’s U.S. launch. “Clinical evidence and experience with more than 50,000 patients treated to date in nearly 60 countries suggests the Cypher Stent represents the beginning of a new era in interventional cardiology—an era in which the combination of drugs and devices substantially improves patient outcomes.”

    DES technology was regarded to be such a significant improvement on current bare metal stent technology that the Centers for Medicare and Medicaid services (CMS) approved Cypher’s incremental reimbursement in August 2002, a full nine months before J&J launched Cypher in the U.S. The new policy provided significant incremental reimbursement over and above 2003’s bare metal stent reimbursement levels—undoubtedly due to Cypher’s demonstrated sustained reduction in blockage incidence by over 90 percent in Cordis’ landmark U.S. SIRIUS trial.

    A number of other medical technology giants were racing to commercialize their own DES products that year as well—J&J was simply the first to reach the U.S. market, granting it a sizeable head start. Around the same time J&J was gearing up to launch Cypher, Boston Scientific Corp. had achieved CE mark approval for its Taxus paclitaxel-eluting coronary stent. Taxus launched in the U.S. in March 2004, almost a full year behind Cypher. Paclitaxel, Boston Scientific’s drug of choice for the Taxus DES, is also used as a chemotherapy medication to treat a number of types of cancer.

    “The approval of the Taxus system marks an important opportunity for clinicians in the United States,” said Gregg Stone, M.D., then vice chairman of the Cardiovascular Research Foundation at the Lenox Hill Heart and Vascular Institute in New York, and principal investigator of the Taxus IV clinical trial. “In paclitaxel, we now have a multi-functional drug that is safe and highly effective. The Taxus system has shown impressive results across a wide range of patients. Its performance has been particularly impressive in challenging cases such as patients with diabetes, small vessels, and long lesions.”

    Guidant Corporation—which Boston Scientific acquired in 2015, after settling a lawsuit with J&J over the deal—had its own stent in the ring around that time, this one coated in everolimus, a sirolimus derivative used to prevent organ transplant rejection and treat renal cell cancer. However, rather than bringing its product to market itself, in February 2004 Guidant began a deal with Cordis to co-promote Cypher and assist the company in developing a Cypher stent utilizing Guidant’s stent delivery system. The agreement granted Guidant immediate entry into the U.S. DES market and settled ongoing stent-related patent disputes between the companies.

    Medtronic was also in the midst of clinical trials for its own Endeavor phosphorylcholine-coated DES in 2003, but did not achieve FDA approval and launch of the device until 2008, though it was the first DES approved in four years. Phosphorylcholine, unlike the other drug compounds used previously, is exclusively meant to prevent coronary artery blockage.

    Today, a majority of stents used in interventional cardiology procedures are coated in some antiproliferative pharmaceutical agent to prevent restenosis. J&J exited the DES market in 2011 due to safety concerns and fierce competition from rival products, but the market remains strong—according to Grand View Research, it was valued at $5.6 billion in 2015 with major players Boston Scientific, Medtronic, Abbott Laboratories, Biosensors International, Biotronik, Lepu Medical Technology, Terumo Medical, Cook Medical, Shandong JW Medical Systems, and Stentys leading the charge. 
    Related Searches
    • medical device
    • technology
    • medtronic
    • cancer
    Related Knowledge Center
    • Cardiovascular
    Suggested For You
    FDA Initiates Device Development Challenge to Help Combat Opioid Crisis FDA Initiates Device Development Challenge to Help Combat Opioid Crisis
    Boston Scientific Launches HeartLogic Heart Failure Diagnostic in Europe Boston Scientific Launches HeartLogic Heart Failure Diagnostic in Europe
    FDA Approves Abbott FDA Approves Abbott's Xience Sierra Everolimus-Eluting Coronary Stent
    3 Critical Considerations for U.S. Medical Device Commercialization 3 Critical Considerations for U.S. Medical Device Commercialization
    Boston Scientific Responds to Boston Scientific Responds to '60 Minutes' Transvaginal Mesh Report
    FDA Seeks Permanent Injunctions Against Two Stem Cell Clinics FDA Seeks Permanent Injunctions Against Two Stem Cell Clinics
    Driving Innovation and Improving Quality with 3D Printing Driving Innovation and Improving Quality with 3D Printing
    Boston Scientific Closes NxThera Acquisition Boston Scientific Closes NxThera Acquisition
    Quality Nightmares #38: Audit Selection Quality Nightmares #38: Audit Selection
    Software Validation: How It Should Be Done Software Validation: How It Should Be Done
    Positive Late-Breaking Data Unveiled for Boston Scientific Positive Late-Breaking Data Unveiled for Boston Scientific's Deep Brain Stimulation Study
    FDA Authorizes First Test for Emerging Pathogen Candida Auris FDA Authorizes First Test for Emerging Pathogen Candida Auris
    FDA Releases Medical Device Safety Action Plan in Effort to Modernize Approach FDA Releases Medical Device Safety Action Plan in Effort to Modernize Approach
    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

    Related Breaking News

    • Diagnostics | Digital Health | Neurological
      FDA Initiates Device Development Challenge to Help Combat Opioid Crisis

      FDA Initiates Device Development Challenge to Help Combat Opioid Crisis

      The agency will work closely with selected applicants to accelerate product development.
      U.S. Food and Drug Administration 05.31.18

    • Cardiovascular | Diagnostics
      Boston Scientific Launches HeartLogic Heart Failure Diagnostic in Europe

      Boston Scientific Launches HeartLogic Heart Failure Diagnostic in Europe

      First and only heart failure diagnostic tool proven to detect 70 percent of heart failure events several weeks in advance.
      PR Newswire 05.29.18

    • Cardiovascular | Surgical
      FDA Approves Abbott

      FDA Approves Abbott's Xience Sierra Everolimus-Eluting Coronary Stent

      New features help doctors treat more difficult-to-reach blockages in patients' arteries.
      PR Newswire 05.23.18


    • 3 Critical Considerations for U.S. Medical Device Commercialization

      3 Critical Considerations for U.S. Medical Device Commercialization

      The step-by-step process of working with the FDA to bring a medical device to the U.S.
      Michael Lynch, Managing Consultant, Intertek 05.18.18

    • Materials | Surgical
      Boston Scientific Responds to

      Boston Scientific Responds to '60 Minutes' Transvaginal Mesh Report

      The company released an open letter denying 60 Minutes' claims of using a counterfeit Chinese plastic for its mesh products.
      Boston Scientific 05.14.18

    Loading, Please Wait..

    Trending
    • Monkeypox Outbreak Driving New IVD Device Development
    • M1 MedTech Announces Fall 2022 Cohort
    • Preceptis Medical’s Tympanostomy Tube System Cleared For Expanded Indications
    • Pulsed Field Ablation Tech Gaining Popularity
    • Edwards' PASCAL Precision Gains EU Nod
    Breaking News
    • EchoNous Partners with Samsung
    • Solid Growth Forecast for Global Ostomy Devices Market
    • KA Imaging's Reveal 35C Images Increase Lung Lesion Visibility
    • Respira Technologies Appoints Brian Quigley as CEO
    • Nikki Troiano Gainey Joins RIVANNA Board
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • Parylene Coatings for Medical Device Technologies
    • Nearshoring Trends in Medtech Manufacturing
    • 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

    IFIC 2022 Food & Health Survey Highlights Eating Behavior Trends
    Icon Foods Appoints Operations and Marketing Leaders
    Annatto Tocotrienol Shown to Improve Weight Loss and Inflammation Markers in Patients with NAFLD
    Coatings World

    Latest Breaking News From Coatings World

    Birla Carbon, NREL Collaboration to be Presented at ACS Conference
    Coating Resins Market Worth $70.9 Billion by 2027: MarketsandMarkets
    PPG Appoints Brad Budde Vice President and Chief Digital Officer
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    EchoNous Partners with Samsung
    Solid Growth Forecast for Global Ostomy Devices Market
    KA Imaging's Reveal 35C Images Increase Lung Lesion Visibility
    Contract Pharma

    Latest Breaking News From Contract Pharma

    GRAM to Fill and Finish Smallpox/Monkeypox Vaccines
    bluebird bio Wins FDA Approval of ZYNTEGLO
    Pace Life Sciences Acquires Meridian BioGroup
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Sephora at Kohl’s to Expand Sephora Presence to All 1,100+ Kohl’s Locations
    Emma Watson to Front New Fragrance Campaign for Prada
    The Estée Lauder Companies Delivers Strong Results in Fiscal 2022
    Happi

    Latest Breaking News From Happi

    Amorepacific, MIT Develop World's First Chip-less Wireless Electronic Skin Enabled by Semiconductors
    Maesa Launches Itk Skincare with TikTok Stars Brooklyn and Bailey McKnight
    Skin Delivery Formulation
    Ink World

    Latest Breaking News From Ink World

    Xeikon to Introduce TITON Food-Safe Dry-Toner Technology at Labelexpo Americas 2022
    Smurfit Kappa Employees Charity Cycle Across Europe
    ProAmpac’s Rocky Mount, VA Facility Receives ISCC Plus Certification
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    ePac makes big announcement, Avery Dennison debuts new technology and more
    Techkon USA announces latest handheld spectrodensitometer
    Maxcess China now manufacturing solid dies in Huzhou
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    INDA Appoints Director of Membership and Industry Relations
    Nexwear Acquires Incontinence Products Brand Lily Bird
    Because Market Expands into Retail Stores
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Theragen Receives Patent for Spine Fusion Bone Growth Stimulator System
    Study: BONESUPPORT’s CERAMENT G Can Help Save Infected Limbs
    Zavation’s Cervical Intervertebral Body Fusion Device Cleared by FDA
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    NREL, Birla Carbon Collaboration to be Shown at ACS Conference
    ORNL Celebrates Launch of Frontier, the World’s Fastest Supercomputer
    DuPont Names 2022 Lavoisier and Pedersen Award Medalists

    Copyright © 2022 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