All Clarivate websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.

More information on our cookie policy.

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
  • Special reports
    • Aging
    • Artificial intelligence
    • Coronavirus
    • IVDs on the rise
    • Top Biopharma Trends of 2021
    • Top Med-tech Trends of 2021
    • Premium reports
      • BioWorld Financings Reports
      • Disease Incidence & Prevalence Summaries

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Friday, August 19, 2022
Home » Blogs » BioWorld MedTech Perspectives » Three stories for August 2012

BioWorld MedTech Perspectives
BioWorld MedTech Perspectives RSS FeedRSS

BioWorld MedTech / National Institutes of Health

Three stories for August 2012

Aug. 31, 2012
By Mark McCarty
No Comments

Sometimes news comes in bunches. That’s not typically the case in the month of August, which is ordinarily a pretty quiet month. Not this year, though. Here are three stories that stick out, in one case like a sore thumb.

Post-market studies for ICD leads

FDA announced it will require section 522 studies for a range of ICD leads made by St. Jude Medical. This is not the first time the new FDA has required 522 studies for groups of devices as the 522 orders for surgical meshes, hip implants, and dynamic spinal stabilization systems suggest. I might add that companies whose wares have not presented statistically significant problems have been forced into the 522 march.

The lesson here is that a post-market 522 study is now the quasi-official FDA response to device problems that are not already tracked in a very extensive registry, and industry knows it. What will industry think about investing in the U.S. in the years ahead once they have to factor the cost of these studies into the product life cycle?

Hauser’s paper on abrasions: a correlation with extrusion?

Robert Hauser, MD, recently published in Europace on the matter of abrasions to St. Jude leads coated with the Optim co-polymer material. It’s another piece of news that could spell danger for patients and for the company … or not.

One thing Hauser’s piece did not explain was whether a correlation exists between abrasion from external sources and externalization of conductors. Maybe there aren’t a lot of data on this. I can’t seem to locate anything on this for ICD leads in general, let alone anything specific to the Optim coating. Will it turn out that the correlation between abrasion and externalization is puny?

One of the difficulties behind this discussion is that there are a lot more patients around who have had an ICD for some years than there were in times gone by. Consequently, electrophysiologists are cramming these skinnier leads into some spaces where there is already a lead that has gone kaput. Ergo, a higher rate of abrasions and externalizations might be partly or even principally due to the contortions a lead is exposed to in order to cram it into a tight anatomical space.

This is not a meaningless consideration. If there’s already a lead in there and you as a physician always resort to a skinny lead to replace a dead lead, the narrower lead already has a problem.

So before we wish skinny ICD leads out of existence by beating the daylights out of St. Jude, maybe we better find out if there is a correlation between abrasion and extrusion, and whether these leads are being used in ways that make it tough to avoid problems to begin with.

NEJM article on NIH spending

I mentioned at the outset that one of these three stories stuck out like a sore thumb. Here it is.

Those who have watched the MDD Perspectives blog for some time know how annoying I find the entire NIH funding discussion. Well, it’s still annoying.

I won’t carp about the cancer-versus-Alzheimer’s funding thing, but the authors of the paper on NIH spending in the Aug. 23 edition of the New England Journal of Medicine use advances in heart disease to justify more spending at NIH and the National Science Foundation. But really, doesn’t the medical device industry deserve most of the credit?

Another point raised in this and other arguments like it is that people with PhDs and MDs will find themselves unemployed. Well, there’s a lot of that going around lately and it’s no reason to throw taxpayer money at medical research. By that logic, anyone with a PhD in particle physics or a JD in constitutional law deserves to be employed via federal funding just by virtue of having a sheepskin. You never hear anyone sweating bullets over someone with a Bachelor’s degree in criminology, but if you have a PhD in a life science, well by golly, pull up your chair to the trough!

I dare someone who supports gobs of money for NIH to say “FDA needs it more. We’re okay with NIH funding where it is.” Why will that never happen? Because possession of a PhD does not blunt self-seeking behaviors even a tiny bit.

Funny how human nature never changes, isn’t it?

You must login or register in order to post a comment.

Report Abusive Comment

Popular Stories

  • Free access to BioWorld coronavirus articles

    BioWorld
    The articles in this collection are from BioWorld’s ongoing coverage of the COVID-19 coronavirus pandemic. They are available for free with registration. Note...
  • Today's news in brief

    BioWorld
    BioWorld briefs for Aug. 19, 2022.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for Aug. 19, 2022.
  • Pig organ cells

    Whole body cellular function recovery in pigs after death

    Science
    A new system for restoring cell function and tissues in mammals after death could expand the availability of organs for transplantation. The research also opens...
  • TPOXX

    Siga leads monkeypox antiviral research, amid lack of interest from big pharma

    BioWorld
    After declarations from the World Health Organization and the U.S. government that monkeypox is a public health emergency, attention is turning to the pharma...
black cortellis ad

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription.

Subscribe
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Archives
    • Today's news
    • Search BioWorld Science
    • About
  • More
    • About
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
Follow Us

Copyright ©2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing