NCHR’s testimony about Endologix AFX endovascular graft system (EVAR) at the FDA Advisory Panel

November 2, 2021

I’m Dr. Diana Zuckerman, president of the National Center for Health Research.  I appreciate the opportunity to speak today.  Our center is a nonprofit think tank that scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products.  

My perspective today is based on my post-doctoral training in epidemiology and public health, and as a former faculty member and researcher at Vassar, Yale, and Harvard.  I’ve also worked at the U.S. Department of Health and Human Services, the U.S. Congress, and the White House.  In my current position, I frequently testify about the safety and effectiveness of medical products.

My goal today is to help you make sense of the conflicting data that have been presented.

The conflicting results are clearly influenced by several basic differences in the studies and the anecdotal clinical experiences that you’ve heard today:

  • The number of patients being described (anecdotally or in research data).
  • The number of months or years of follow-up
  • The skill of the surgeons: one surgeon or one facility vs many surgeons from across the country
  • Any benefits that might be related to targeting a specific subpopulation of patients with specific unusual anatomy

We believe that it is FDA’s job to focus on what is best for patients across the country.

Here’s the chart of the Kaiser Permanente data that FDA included in their summary memorandum for this meeting.  I think these data are very compelling because of the larger number of patients and the 2-year follow-up, and the consistent results showing more problems with the AFX2 device.

It’s important to note that the FDA summary found that regardless of the type of data analyzed, all the data consistently showed an increase in problems with the Endologix EVAR devices.  Those types of studies include:

  • Ongoing real-world studies
  • Published abstracts 
  • Peer-reviewed literature
  • MDR and Endologix complaint data
  • Endologix LEOPARD trial
  • Endologix VQI analysis

I will also quote the summary by the FDA, which stated that “Based on an analysis of the currently available data, there appears to be a higher than expected rate of Type III endoleaks with the AFX System, regardless of the device iteration.”

The FDA also concluded that “There is residual uncertainty whether the mitigation measures implemented by Endologix have been adequate to address the Type III endoleak concerns for the currently marketed AFX2 device.” 

I want to raise another issue, however.  Is FDA asking you the right questions?

  • Patients care how beneficial the device is to them, to help them live longer with better quality of life, not just the percentage increase in a specific type of endoleak.
  • There are other EVARs on the market that are proven to be safer.  Isn’t that more important than whether the benefits outweigh the risks of the AFX2 device compared to no EVAR? 

As you heard from Dr. Art Sedrakyan, there are other useful data available, and I urge the FDA to make sure of them.

The MDEpiNet is the Medical Device Epidemiological Network, a public/private partnership between the FDA and stakeholders.  I’m on the Executive Committee of MDEpiNet, and I urge the FDA to make use of the data they can provide, including the National and International Vascular Device Research Initiatives. 

This also includes the Coordinated Registry Network (CRNs), which provides real-world evidence that can inform the FDA and this Advisory Committee

The CRN for vascular devices can compare the experiences of patients with different types of EVAR devices, and different types of Endologix AFX devices in different countries and worldwide.

In conclusion, based on the totality of evidence, I would not want a family member to rely on the Endologix AFX EVAR devices.  The company should have provided better clinical trial data before the FDA put them on the market and put revised versions of the device on the market, and the AFX2 device should not remain on the market while waiting for longer term data to determine if it is as safe as other EVAR devices.