BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
  • Special reports
    • Aging
    • Biosimilars
    • Artificial intelligence
    • Coronavirus
    • IVDs on the rise
    • Radiopharmaceuticals
    • Science '22 in Review
    • Top Biopharma Trends of 2022
    • Top Med-tech Trends of 2022
    • Premium reports
      • BioWorld Financings Reports
      • Disease Incidence & Prevalence Summaries

BioWorld. Link to homepage.

  • sign in
  • Sign Out
  • My Account
Subscribe
BioWorld - Monday, September 25, 2023
Home » Blogs » BioWorld MedTech Perspectives » Could Medtronic eventually shed Infuse?

BioWorld MedTech Perspectives
BioWorld MedTech Perspectives RSS FeedRSS

BioWorld MedTech / Cardiovascular / Orthopedics / FDA

Could Medtronic eventually shed Infuse?

Sep. 26, 2011
By Omar Ford
No Comments

After Johnson & Johnson (J&J, New Brunswick, New Jersey) said that it was going to discontinue its work in the drug eluting stent (DES) market, my eyes then began to focus on Medtronic (Minneapolis), which has recently taken a beating in the wallet and court of public opinion with its bone growth product, Infuse.

I began asking myself how much longer before Medtronic finally abandons ship on this application.

I mean if there ever was a shining example of a device that has caused problems for a company then Infuse is it.

The med-tech juggernaut was dealt what one would call a disastrous blow when a published study from the Spine Journal linked its Infuse to a condition that can cause infertility in men. A subsequent article the journal published suggested that some researchers who were involved in previous studies of Infuse did not disclose many serious side effects.

To combat this, the company provided $2.5 million that will allow Yale University (New Haven, Connecticut) to conduct two independent reviews of the safety and effectiveness of Infuse, which has been on the market since 2002. Medtronic said it will provide Yale with all of the data from the clinical trials it sponsored, and all the side effect reports provided to the FDA.

On top of that, a much stronger version of Infuse, named Amplify wasn’t granted FDA approval due to concerns about possible cancer risks.

My colleague, Mark McCarty, Medical Device Daily, Washington Editor, summed up the situation perfectly in his August 5, blog entry on Medtronic and Infuse.

“So now Medtronic is faced with declining sales of its bone morphogenic products, a ton of negative press, and the possibility that FDA will force the firm to either file an IDE for these other indications or require something approximating a risk evaluation and mitigation program to tamp down off-label use. Either way, sales are going to suffer,” McCarty writes.

While declining sales almost seem like a given – will the decrease in revenue for these products be so much so that it would prompt Medtronic to cut its losses and move on?

It could just be a matter of time.

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

Report Abusive Comment

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for Sept. 22, 2023.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for September 22, 2023.
  • Hands holding torn contract

    Quite a fix: Orthofix sacks three top execs

    BioWorld MedTech
    Orthofix Medical Inc. terminated its CEO, chief financial officer and chief legal officer in a move that plunged the stock from $18.63 at Monday’s close to $13.01...
  • Illustration of Alzheimer’s in the brain.

    Study identifies cause of death for Alzheimer’s neurons

    BioWorld
    By creating a new mouse model of Alzheimer’s disease that better recapitulated how the disease plays out in humans, investigators at KU Leuven have gained new...
  • 3D illustration of cancer in crosshairs

    Dato data lack means upside for Gilead; Padcev 'must-win' does win

    BioWorld
    Upbeat phase III findings outweighed less encouraging late-stage trial news, as big pharma provided a mixed bag of cancer findings – with one data batch to form...
BioFuture 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
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • 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 ©2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing