• 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
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    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
    Vascular Surgeon Imprisoned and Fined for Decade-Long Healthcare Fraud

    Remote Monitoring, Digital Health Help Advance Wound Care Treatment

    MLM Biologics Developing Wound Infection Prevention Device for Military

    NovaScan, PHC Corporation Working on Skin Cancer Detection Device

    Ur24Technology Granted Medicare Reimbursement for External Catheter System
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Checking Up on Surgical Robotics

    Building a Network: How Synchron Is Developing a New Device—and a New Market

    Six Lessons Learned on Developing a Strong Company Culture

    As Hiring Slows, Companies Look Inward to Fulfill Talent Needs

    Artificial Intelligence: Medtech Opportunity or Health Danger?
    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
    Fusion Biotec Inc.

    Arthur G. Russell Co. Inc., The

    Providence Enterprise USA Inc.

    Cirtec Medical

    LEMO USA Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3 Key Elements to Consider When Managing a Medtech Sales Force

    Tech-Enabled Virtual Speech Therapy Improves Speech & Communication Skills

    Practical Strategies for Digitization and Integration in Medtech Manufacturing

    Sensors: The Heart of Minimally Invasive Equipment Technology

    Optimizing UX for 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
    Fusion Biotec Inc.

    Arthur G. Russell Co. Inc., The

    Providence Enterprise USA Inc.

    Cirtec Medical

    LEMO USA 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
    • 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

    What’s New with TAVR?

    ...

    What’s New with TAVR?
    Maria Shepherd, President and Founder, Medi-Vantage04.03.19
    Transcatheter aortic valve replacement (TAVR), once the last resort for patients so sick or elderly they were deemed unable to outlive surgical aortic valve replacement performed via open-heart surgery, has now been proven to offer benefits for younger, low-risk patients, based on the findings from two large clinical trials (Table 1). The first was published in The New England Journal of Medicine (Popma, et. al.),1 and the second—the Partner ll trial2—was sponsored by Edwards Lifesciences.


    Table 1: Death and disabling stroke rates in the Partner II trial (at 1 year)2 and the Popma, et. al trial (at 2 years)1.

    Both studies were randomized controlled studies that followed death, disabling stroke, and hospitalization at one- and two-years post-procedure. In the Partner II trial, the rates of death and disabling stroke were 2.9 percent with surgical aortic valve replacement performed via open heart surgery vs. 1 percent with the TAVR procedure. The Popma, et. al. study found death or disabling stroke rates of 6.7 percent with surgical aortic valve replacement vs. 5.3 percent with TAVR at two years.


    Table 2: The difference in the cost of a TAVR procedure when compared to surgical aortic valve replacement.3

    Further, a significant cost argument can be made for TAVR. In the Partner II trial, procedure cost was approximately $20,0003 higher with TAVR than surgical aortic valve replacement performed via open heart surgery. The total cost difference between surgical aortic valve replacement and TAVR, however, show costs were just $2,888 more with XT-TAVR (P=0.014) and $4,155 lower with S3-TAVR (P<0.001). This was due to a reduction in length of stay with TAVR. In addition, follow-up costs were significantly lower with TAVR (between $9,304 and $11,377; P<0.001) than with surgical aortic valve replacement (Table 2). Over the lifetime of the patient, TAVR is projected to lower the total cost of care by an average of $9,000.

    Full disclosure—the trials were sponsored by Edwards Lifesciences and Medtronic plc, the only medical device manufacturers who have obtained regulatory approval or clearance of TAVR valves.

    With traditional surgical aortic valve replacement, the cardiac surgeon removes the diseased valve and sutures in a replacement. The diseased valve is completely removed from the heart. In comparison, Edwards’ valve is compacted onto a balloon catheter. When it reaches the aorta, the physician inflates the balloon to expand the TAVR valve to replace the failing valve of the patient. Medtronic’s TAVR valve, on the other hand, is nitinol based. After transfemoral access, the physician pulls back the sheath, releasing the new valve into place in the aorta.

    Surgical aortic valve replacements have been performed for decades, and in multiple previous studies in intermediate-risk TAVR patients, data demonstrated that complication rates are equivalent or better for TAVR than for intermediate-risk surgical aortic valve replacement patients.4 Cardiac surgeons recognize valves placed during aortic valve replacement procedures will last at least 10 to 15 years. The next step for clinical studies will be to determine if TAVR valves have equivalent or longer lasting survival rates.

    Why This Is Important
    These trial results are a shot in the arm for minimally invasive transcatheter valve procedures, and a shot over the bow for open-heart surgery. Complications have proven to be lower with TAVR for stroke and death compared to surgical aortic valve replacement, and interventional cardiologists believe5 it will transform the standard of care for the majority of patients with deteriorating aortic valves.

    FDA is expected to approve the procedure for patients judged to be low-risk. This means up to 20,000 more patients each year could meet the new guidelines for TAVR. Currently, approximately 60,000 patients diagnosed as intermediate- and high-risk can get the operation (Table 3).


    Table 3: Future eligibility for TAVR and the effect on procedure rates.

    We all know what happens in open-heart surgical procedures like surgical aortic valve replacement. The patient’s chest is cracked, and the heart is stopped to insert a replacement aortic valve. Recovery can take several months, and complication rates are high. In a TAVR procedure, transfemoral access is gained through the groin, the TAVR catheter is introduced, and it is threaded up to the heart—similar to the method to place a stent. The procedure is performed under conscious sedation, and like any interventional procedure without complications, the patient goes home in a few days.

    These results would seem to shift the treatment paradigm toward more patients being prescribed for TAVR. Heart surgeons agree. “If I were a patient, I would choose TAVR,” said Dr. Gilbert Tang, a heart surgeon at the Icahn School of Medicine at Mount Sinai in New York, N.Y., who was not involved in the research.5

    Failure of the aortic valve starts in patients with a hardening of the valve controlling blood flow from the heart to the body. The primary risk factor is age, and there is no cure other than to replace the valve.

    The Medi-Vantage Perspective
    Cardiac surgery of any form is a highly profitable money maker for hospitals; as such, hospital administrators are faced with a dilemma. Should they market TAVR to patients much in the same way as the Intuitive Surgical robotics system has been successfully marketed, or take the financial downside when lower-risk patients start demanding the TAVR procedure? TAVR valves cost more than surgical aortic valve replacement, and insurers are reported to pay the same amount for both procedures,5 so the lonely loser here is the hospital. Edwards Lifesciences and Medtronic aren’t taking that risk and are providing TAVR physician finders on their respective websites. Edwards and Medtronic are enjoying their position as first to market but, in the future, many more heart valves will be coming, and aortic valve prices will drop (by how much is anyone’s guess). In the coming years, medical device price strategy and commercialization strategy research will make or break fast-following aortic valve medical devices. 

    References
    1. http://bit.ly/mpo190401
    2. http://bit.ly/mpo190402
    3. http://bit.ly/mpo190404
    4. http://bit.ly/mpo190405
    5. http://bit.ly/mpo190403

    Maria Shepherd has more than 20 years of leadership experience in medical device/life science marketing in small startups and top-tier companies. After her industry career, including her role as vice president of marketing for Oridion Medical, where she boosted the company valuation prior to its acquisition by Covidien/Medtronic, director of marketing for Philips Medical, and senior management roles at Boston Scientific Corp., she founded Medi-Vantage. Medi-Vantage provides marketing, business strategy, and innovation research for the medical device, diagnostic, and digital health industries. The firm quantitatively and qualitatively sizes and segments opportunities, evaluates new technologies, provides marketing services, and assesses prospective acquisitions. Shepherd has taught marketing and product development courses and is a member of the Aligo Medtech Investment Committee (www.aligo.com). She can be reached at 855-343-3100. Visit her website at www.medi-vantage.com. 
    Related Searches
    • medical
    • clinical trials
    • robotics
    • medical device manufacturers
    Related Knowledge Center
    • Cardiovascular
    Suggested For You
    Medtronic Sees Revenue Losses Due to COVID-19 Pandemic Medtronic Sees Revenue Losses Due to COVID-19 Pandemic
    Medtronic Releases Evolut Low Risk Bicuspid Study Results Medtronic Releases Evolut Low Risk Bicuspid Study Results
    Medtronic Launches MedTech Innovation Accelerator in Shanghai Medtronic Launches MedTech Innovation Accelerator in Shanghai
    New Hybrid Closed-Loop Insulin Pump Proves Hard to Use for Some Patients with Diabetes New Hybrid Closed-Loop Insulin Pump Proves Hard to Use for Some Patients with Diabetes
    Study: Medtronic Study: Medtronic's Antibiotic Envelope Markedly Cuts Risk of Cardiac Device-Related Infection
    Medtronic Medtronic's Covidien Pays $17.5M to Resolve Catheter Kickback Case
    Edwards to Buy Corvia, Mitralign Assets Edwards to Buy Corvia, Mitralign Assets
    Insulet Appoints Venture Fund Executive to its Board of Directors Insulet Appoints Venture Fund Executive to its Board of Directors
    Former Medtronic Chairman & CEO Joins Surgical Theater Former Medtronic Chairman & CEO Joins Surgical Theater's Advisory Board
    Medtronic Medtronic's Resolute DES Platform Gains FDA Nod for Chronic Total Occlusion
    Edwards’ PASCAL Transcatheter System Receives CE Mark Edwards’ PASCAL Transcatheter System Receives CE Mark
    Medtronic Launches Deep Brain Stimulation for Medically-Refractory Epilepsy Medtronic Launches Deep Brain Stimulation for Medically-Refractory Epilepsy
    Medtronic Comments on Revised IN.PACT Post Market Study Data Medtronic Comments on Revised IN.PACT Post Market Study Data
    Medtronic Medtronic's Personalized Closed Loop Insulin Pump System Wins Breakthrough Status
     Baxter Signs Open Data Pledge to Improve Patient Safety Baxter Signs Open Data Pledge to Improve Patient Safety

    Related Breaking News

    • Medtronic Sees Revenue Losses Due to COVID-19 Pandemic

      Medtronic Sees Revenue Losses Due to COVID-19 Pandemic

      The company says it is well positioned for recovery.
      Globe Newswire 04.22.20

    • Cardiovascular
      Medtronic Releases Evolut Low Risk Bicuspid Study Results

      Medtronic Releases Evolut Low Risk Bicuspid Study Results

      Low rates of paravalvular leak, high survival observed in late-breaking clinical trial.
      GlobeNewswire 03.30.20

    • Medtronic Launches MedTech Innovation Accelerator in Shanghai

      Medtronic Launches MedTech Innovation Accelerator in Shanghai

      Early-stage business accelerator to empower local medtech innovation and enhance Medtronic China's industry leadership.
      Medtronic 03.26.19


    • Patient Monitoring
      New Hybrid Closed-Loop Insulin Pump Proves Hard to Use for Some Patients with Diabetes

      New Hybrid Closed-Loop Insulin Pump Proves Hard to Use for Some Patients with Diabetes

      Results of a real-world study of Medtronic's MiniMed 670G found some difficulties among users.
      The Endocrine Society 03.25.19

    • Cardiovascular
      Study: Medtronic

      Study: Medtronic's Antibiotic Envelope Markedly Cuts Risk of Cardiac Device-Related Infection

      Roughly 1.5 million patients receive a cardiac implantable electronic device worldwide every year.
      American College of Cardiology 03.18.19

    Loading, Please Wait..

    Trending
    • Philips Names New Supervisory Board Chairman
    • A New Approach To Post-Market Surveillance
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
    • Vascular Surgeon Imprisoned And Fined For Decade-Long Healthcare Fraud
    Breaking News
    • Vascular Surgeon Imprisoned and Fined for Decade-Long Healthcare Fraud
    • Remote Monitoring, Digital Health Help Advance Wound Care Treatment
    • MLM Biologics Developing Wound Infection Prevention Device for Military
    • NovaScan, PHC Corporation Working on Skin Cancer Detection Device
    • Ur24Technology Granted Medicare Reimbursement for External Catheter System
    View Breaking News >
    CURRENT ISSUE

    May 2023

    • Computer Concepts for Medical Device Design
    • IVD Manufacturers Are Being Put to the Test
    • The New State of Medtech Outsourcing
    • 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

    Premium Label & Packaging Solutions Receives Safe Quality Food (SQF) Certification
    Inulinase Enzymes May Benefit Gut Symptoms of FODMAP Digestion
    Verdure Sciences’ Boswellia Ingredient Receives USP Verification
    Coatings World

    Latest Breaking News From Coatings World

    BASF Celebrates 10 Years of its Northeast Research Alliance in the U.S.
    BCF Elects Sharon Harte Its First Female President
    OQ Chemicals Launches Cost-Cutting Program and Organizational Realignment in Germany
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Vascular Surgeon Imprisoned and Fined for Decade-Long Healthcare Fraud
    Remote Monitoring, Digital Health Help Advance Wound Care Treatment
    MLM Biologics Developing Wound Infection Prevention Device for Military
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Catalent Adds New Cryogenic Capabilities at Japanese Facility
    Lifecore Biomedical Enters into $150M New Financing Deal
    WuXi Biologics Receives 2023 ISPE Facility of the Year Award
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    How Robots & Artificial Intelligence are Transforming Unilever's Material Innovation Factory
    Top 10 Most Popular Hair Care Brands in the U.S.—Ranked by Searches
    Aloette Cosmetics Launches Daily Mineral Shield Sunscreen
    Happi

    Latest Breaking News From Happi

    Kérastase Donates $25,000 to The Trevor Project
    Aveda Launches Hypernature Artist Collection
    Amika Leads as the Most Popular Hair Care Brand in the US: Curl Centric
    Ink World

    Latest Breaking News From Ink World

    BCF Elects Sharon Harte First Female President in Its History
    Weekly Recap: INX Digital, Mexar and hubergroup Top This Week’s Stories
    Richnerstutz AG Acquires an EFI VUTEk Q5r Superwide Roll-to-Roll Printer
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Mactac acquires Label Supply, Beontag grows and more
    Sun Chemical releases Spring 2023 Regulatory Newsletter
    Tageos unveils new RAIN RFID inlays
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: Corman, Tosama Develop Biodegradable Plastic Tampon Applicator, Trevira Changes Name
    Suominen Appoints SVP, Transformation Management Office
    Minnesota Signs PFAS Ban in Consumer Products
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    AlloSource Launches AlloMend Duo Acellular Dermal Matrix
    TendoNova Inks Partnership With AcCELLerated Biologics
    Stryker Achieves First Surgeries Using Q Guidance System with Cranial Guidance Software
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Partner Workshops Start Solliance 2.0
    Weekly Recap: Smart Skis, Universal Display Top This Week’s Stories
    Wiliot Appoints Antony Yousefian as VP of Climate & Circularity

    Copyright © 2023 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