By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Health Works CollectiveHealth Works CollectiveHealth Works Collective
  • Health
    • Mental Health
    Health
    Healthcare organizations are operating on slimmer profit margins than ever. One report in August showed that they are even lower than the beginning of the…
    Show More
    Top News
    How Not to Become a Victim of Medical Scams
    How Not to Become a Victim of Medical Scams
    December 22, 2021
    11 Ways You Can Care for Your Elder Family Members Health
    11 Ways You Can Care for Your Elder Family Members Health
    April 6, 2022
    How Can Brain Injury Lead To Dangerous Long-Term Effects?
    How Can Brain Injury Lead To Dangerous Long-Term Effects?
    August 30, 2022
    Latest News
    7 Most Common Healthcare Accreditation Programs: Which Should You Use?
    August 20, 2025
    Hospital Pest Control and the Fight Against Superbugs
    August 20, 2025
    Hygiene Beyond The Clinic: Attention To Overlooked Non-Clinical Spaces
    August 13, 2025
    5 Steps to a Promising Career as a Healthcare Administrator
    August 3, 2025
  • Policy and Law
    • Global Healthcare
    • Medical Ethics
    Policy and Law
    Get the latest updates about Insurance policies and Laws in the Healthcare industry for different geographical locations.
    Show More
    Top News
    health suppliments
    Experience Life in a Better Way by Experimenting with Supplements!
    November 15, 2022
    Are There Differences in Medicare Spending Across States?
    September 9, 2017
    Obama: Ryan’s Ideas Are Too Radical Unless They’re Also My Ideas
    April 21, 2011
    Latest News
    How Social Security Disability Shapes Access to Care and Everyday Health
    August 22, 2025
    How a DUI Lawyer Can Help When Your Future Health Feels Uncertain
    August 22, 2025
    How One Fall Can Lead to a Long Road of Medical Complications
    August 22, 2025
    How IT and Marketing Teams Can Collaborate to Protect Patient Trust
    July 17, 2025
  • Medical Innovations
  • News
  • Wellness
  • Tech
Search
© 2023 HealthWorks Collective. All Rights Reserved.
Reading: A Victory for Coverage with Evidence Development
Share
Notification Show More
Font ResizerAa
Health Works CollectiveHealth Works Collective
Font ResizerAa
Search
Follow US
  • About
  • Contact
  • Privacy
© 2023 HealthWorks Collective. All Rights Reserved.
Health Works Collective > Technology > Medical Devices > A Victory for Coverage with Evidence Development
BusinessMedical Devices

A Victory for Coverage with Evidence Development

gooznews
gooznews
Share
3 Min Read
SHARE

A federal study of a new stent designed to prevent repeat strokes was stopped early because 2 1/2 times (14.7%) more people either died or had a repeat stroke after receiving the stent than those who received drugs and counseling (5.8%). The $20 million study, stopped after just 451 stroke victims had been enrolled because of the alarming trend in the results, was sponsored by the National Institute of Neurological Diseases and Stroke.

A federal study of a new stent designed to prevent repeat strokes was stopped early because 2 1/2 times (14.7%) more people either died or had a repeat stroke after receiving the stent than those who received drugs and counseling (5.8%). The $20 million study, stopped after just 451 stroke victims had been enrolled because of the alarming trend in the results, was sponsored by the National Institute of Neurological Diseases and Stroke.

The Gateway-Wingspan system, manufactured by Stryker, was approved by the Food and Drug Administration in 2005 based on “a small, less rigorous study,” according to this morning’s Washington Post. But use has been limited by a decision by the Centers for Medicare and Medicaid Services to deny reimbursement unless patients receiving the device were enrolled in a clinical trial. This “coverage with evidence development” policy began during former CMS director Mark McClellan’s tenure during the Bush administration.

Walter Koroshetz, chief of NIHDK, told the Post, “This is an example of how to do it right.” I partially agree. The government did the right thing, given existing laws and policies. But Stryker should have done the larger trial in the first place. The potential profits from the device, if it was useful, would have far exceeded the $20 million spent by the government to prove it wasn’t.

More Read

Government Pays Bonuses for Increasing Medicaid Expenditures
How The Medical Device Industry Lobbies
Medicare’s Data Release Places More Power in Hands of Informed Medical Consumers
Ways to Enhance Your Hospital’s Instagram Presence
Preclinical Research: An Important Aspect of Drug Development

The company should be asked to reimburse the taxpayers. And this episode shows that the FDA’s device approval process should be made more stringent to require the same kind of trials for devices that it now requires of drugs — the trials that prove with statistical significance that new products do in fact improve public health.

TAGGED:coverage with evidenceFDAgateway-wingspanstent
Share This Article
Facebook Copy Link Print
Share

Stay Connected

1.5kFollowersLike
4.5kFollowersFollow
2.8kFollowersPin
136kSubscribersSubscribe

Latest News

travel nurse in north carolina
Balancing Speed and Scope: Choosing the Nursing Degree That Fits Your Goals
Nursing
September 1, 2025
intimacy
How to Keep Intimacy Comfortable as You Age
Relationship and Lifestyle Senior Care
September 1, 2025
engineer fitting prosthetic arm
How Social Security Disability Shapes Access to Care and Everyday Health
Health care
August 20, 2025
a woman explaining the document
How a DUI Lawyer Can Help When Your Future Health Feels Uncertain
Public Health
August 20, 2025

You Might also Like

Health Affairs Briefing Addresses Costly Consequences of Diabetes Treatment in America

January 12, 2012

Does Your Plastic Surgeon Take Plastic?

August 4, 2011

Connected Health Companies to Watch

June 10, 2013

TEDxCambridge 2011 Twitter Feed

November 20, 2011
Subscribe
Subscribe to our newsletter to get our newest articles instantly!
Follow US
© 2008-2025 HealthWorks Collective. All Rights Reserved.
  • About
  • Contact
  • Privacy
Welcome Back!

Sign in to your account

Username or Email Address
Password

Lost your password?