Tag: Medtronic

Infuse, Medtronic and the Yale University Open Data Access (YODA) Project

Good morning.

Yesterday I was interviewed by a journalist from The Age, and it really shouldn’t have come as a surprise to learn that the article hasn’t reflected the message I thought I was quite clearly giving her.

Here’s the background: Medtronic, a large medical device company, brought to the market Infuse, which is a Bone Morphogenic Protein (rhBMP-2 to be precise).  This is soaked into collagen sponge and placed around fusion sites, and it works on the cellular level to transform cells to make bone.  Simple enough.  It has been used widely, by myself and most other spinal surgeons, to help the body fuse a spinal level.

Eugene Carragee, a prominent Stanford surgeon, raised concerns about Infuse in 2011.  In response to those concerns, Medtronic sponsored a large project in order to address these concerns.  In doing so, they set a new standard in “in the emerging era of open science“.  In fact, they exceeded expectations – not one but two independent groups of researchers were granted access to every last morsel of data that the company had regarding Infuse.  Completely independently, the two groups analysed the data and published their findings recently here and here.

It gives a surgeon and any researcher interested in Infuse confidence knowing that two independent groups produced such similar results, and yet at the same time, each group emphasised different aspects of their results.

In summary, they found:

  • it’s as good as bone graft to create fusion – that’s the key message to take home people.  When a patient’s own bone can’t be used, then we now know that without a doubt Infuse will do as good a job.
  • When used in the anterior neck, it’s associated with increased complications – surgeons have know about this for many years now and it’s no longer used there.
  • complications such as retrograde ejaculation are about as common with Infuse as with bone graft.
  • there is no appreciable increase in the risk of cancer with Infuse – this was a great concern, and although the cancer rates were very slightly higher in the Infuse patients compared to bone graft, it was not higher than the normal population, and after four years there was no difference at all.  I suspect this will turn out to be a statistical anomaly.  Medtronic are continuing to research this area.

If you’ve had a fusion with Infuse, there is not need for concern.  I will continue to use it, as well as similar products, when appropriate, with the patient’s consent.  The journalist and the editors clearly have a newspaper to sell, and boring science is always outweighed by sensationalism.

Medtronic should be commended on what they have done with the YODA project.  With complete transparency, they have opened up their data for not one but two independent reviews, and the results are difficult to argue with.  They have set the standard by which other companies must now live up to – a new era of open science.