• 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
    Cretex Companies CEO Steps Down

    Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread

    Endoscopic Hemostasis Devices Market Valued at $730 Million

    Henry Schein Buys Majority Interest in Prism Medical Products

    Boston Scientific's Vercise Genus DBS Earns FDA Approval
    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
    Concise Engineering

    K-Tube Technologies

    Spectrum Plastics Group

    maxon

    Element
    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
    Spectrum Plastics Group

    Unicep

    Medbio LLC

    Concise Engineering

    FUTEK Advanced Sensor Technology Inc.
    • 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
    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
    • Outsourcing
    • first
    • health
    • medical technology
    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 Columns

    • Cardiovascular
      The Heart of the Matter: Trends in Cardiology

      The Heart of the Matter: Trends in Cardiology

      Of the three major segments of coronary stents, bioabsorbable stents are expected to have the highest growth between now and 2022.
      Maria Shepherd, President and Founder, Medi-Vantage 11.04.20

    • Cardiovascular
      The TAVR Plot Thickens

      The TAVR Plot Thickens

      Transcatheter aortic valve replacement (TAVR) surgery has typically targeted patients considered too risky to undergo open-heart surgery.
      Sam Brusco, Associate Editor 09.06.19

    • Cardiovascular | Diagnostics | Digital Health | Patient Monitoring
      Cardiac Care on the Can

      Cardiac Care on the Can

      ...
      Sam Brusco, Associate Editor 04.03.19


    • Cardiovascular
      What’s New with TAVR?

      What’s New with TAVR?

      ...
      Maria Shepherd, President and Founder, Medi-Vantage 04.03.19

    • Cardiovascular | Digital Health | Neurological
      The Human Cyborg, Circa 2033

      The Human Cyborg, Circa 2033

      ...
      Michael Barbella, Managing Editor 06.04.18

    • Cardiovascular | Digital Health
      Feeding the Medtech Innovation Pipeline

      Feeding the Medtech Innovation Pipeline

      ...
      Maria Shepherd, President and Founder, Medi-Vantage 01.30.18


    • Cardiovascular | Surgical
      Age of Innovation for Valves

      Age of Innovation for Valves

      ...
      David Novotny, Novella Clinical 09.01.17

    • Cardiovascular | Diagnostics
      Changing Administrations and the Strategy for Value-Based Growth in Medtech

      Changing Administrations and the Strategy for Value-Based Growth in Medtech

      ...
      Maria Shepherd, Medi-Vantage 07.26.17

    • Cardiovascular | Diagnostics | Digital Health | Neurological | Patient Monitoring | Surgical
      Four Common Misperceptions of Accelerated FDA Approval

      Four Common Misperceptions of Accelerated FDA Approval

      ...
      Matthew M. Lowe, Executive Vice President, MasterControl 03.07.17


    • Cardiovascular | Diagnostics | Neurological | Patient Monitoring | R&D & Design | Surgical | Testing
      First in Man

      First in Man

      ...
      Steve Maylish, Chief Commercial Officer, Fusion Biotec 03.07.17

    • Cardiovascular | Contract Manufacturing | Materials | R&D & Design
      Critical Aspects for Medical Textile Implant Manufacturing

      Critical Aspects for Medical Textile Implant Manufacturing

      ...
      Rick Crane, Vice President of Innovation Services Group, J-Pac Medical 10.12.16

    • Cardiovascular | Contract Manufacturing | Materials | Testing
      Sterilization Innovations Lead to New Guidance Document

      Sterilization Innovations Lead to New Guidance Document

      ...
      James A. Dunning, QPC Services 05.06.16


    • Cardiovascular
      The Tortuous Trek Toward True Transparency

      The Tortuous Trek Toward True Transparency

      ...
      Michael Barbella , Managing Editor 03.10.16

    • Cardiovascular

      Greatbatch-Lake Region Medical Merger Complete

      ...
      11.11.15

    • Cardiovascular | Contract Manufacturing | Materials | Molding

      Medtech Supplier Consolidation, the Boeing Way

      ...
      Michael Barbella, Managing Editor 11.11.15


    Trending
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Masimo Earns CE Mark For New Fingertip Pulse Oximeter
    • TPI Partners With Zeiss
    • Top 10 Trends In The Medical Device And Equipment Industry
    • Understanding Food-Grade Vs. Biocompatibility For Medical Device Materials
    Breaking News
    • Cretex Companies CEO Steps Down
    • Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread
    • Endoscopic Hemostasis Devices Market Valued at $730 Million
    • Henry Schein Buys Majority Interest in Prism Medical Products
    • Boston Scientific's Vercise Genus DBS Earns FDA Approval
    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

    NIH Study Compares Low-Fat, Plant-based to Low-Carb, Animal-Based Diet
    Gadot Positions Mineral Line for Vegan Market
    Nutritfy India to Launch Global Broadcast Channel Covering Nutrition
    Coatings World

    Latest Breaking News From Coatings World

    LINE-X Launches Dealer Program with International Truck
    PPG Reports Q4, Full-year 2020 Financial Results
    BASF Begins Implementing Ralignment of Global Business Services Unit
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Cretex Companies CEO Steps Down
    Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread
    Endoscopic Hemostasis Devices Market Valued at $730 Million
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Pfizer, BioNTech Enter Vax Pact with COVAX
    FDA Approves Janssen’s CABENUVA
    AGC Biologics Appoints Boulder Site GM
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Coty Appoints Chief Procurement Officer
    Lageen Tubes Launches Mono-Material PE Tube Solutions
    Jason Jones Loses Battle with Covid-19
    Happi

    Latest Breaking News From Happi

    Carol’s Daughter Adds New Hair Products
    Moroccan Gold Series Launches NuDo Shampoo
    Youbody Debuts Waterless Body Wash
    Ink World

    Latest Breaking News From Ink World

    BOBST Demonstrates Future of Flexible Packaging Production at Virtual Open House
    Morancé Soudure France Adds Comexi F2 MC 10-color Flexo Press
    AR Packaging Acquiring Firstan Holdings Ltd
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Gallus planning virtual event for March
    Lemu Group engineers mask-making machine
    Niagara Label upgrades with Nilpeter flexo press
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Freudenberg to Establish Apparel Interlining Competence Centers
    Minet Adds Spunlace Line in Romania
    Lemu Group Engineers Mask-Making Machine
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Cretex Companies CEO Steps Down
    Conformis Enters Development & Supply Agreement with SITES Medical
    Sectra, RSA Biomedical Sign Distribution Agreement for Implant Stability Tool
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    UDC Subsidiary Adesis' Website Wins 2020 MarCom Platinum Award
    Ambiq Wins IoT Semiconductor Company of the Year Award
    Ynvisible Names Michael Robinson CEO, Jani-Mikael Kuusisto SVP Ventures

    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