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Very little news in this news release on device approved for aneurysm treatment


1 Star

Cedars-Sinai Surgeon Uses New Device to Perform First-Ever Surgery

Our Review Summary

A news release announcing a new minimally invasive surgery technique to treat aneurysms of the aorta was surprisingly short on details concerning the main things we want to know: the rates of benefit and harm related to the Valiant Navion thoracic stent graft system, how it compares to other methods to treat these kinds of aneurysms, the cost, its availability and whether it is currently being performed by other surgeons. Unfortunately, none of these important questions is answered in this news release.


Why This Matters

If there is a new and safer way to treat aortic aneurysms, this could be a major public health advance. Though this new stent was approved by the US Food & Drug Administration, readers need more than assurances from the surgeon who performed the operation buttressed by a testimonial from the first patient who was treated. There is astonishingly little “news” in this news release.


Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

No benefits were mentioned other than this treatment might be better than open surgery. The surgeon points out that: “Now, patients can undergo a minimally invasive procedure to fix complex problems of the aorta without having open surgery.”  We have consistently advised readers to be wary of claims about “minimally invasive procedures.”

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

No harms of the new procedure were mentioned. The lone patient who underwent the procedure called it “a difficult surgery” and anticipated feeling better after recovery but we’re not told if the procedure was successful or how long recovery took.

As we’ve written, minimally invasive is still invasive “and thus pose potential harms associated with anesthesia, infection, and bleeding.”

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

Clearly, there was evidence that was reviewed by the FDA prior to approval, yet we get not a single inkling of what that evidence might contain. Again, a missed opportunity to inform the reader.

Does the news release commit disease-mongering?

Not Satisfactory

There is no obvious disease mongering and we learn that “aneurysms are weakening, or bulging, of blood vessels that can rupture and become life-threatening.”  What we don’t get is how common or uncommon such ruptures are, and this would have been a very good educational point to make in this news release.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

Funders of the study are not named (nor is the study that led to the device approval identified or linked). It is good to know that the surgeon featured in the news release, Dr. Azizzadeh, works “in conjunction with medical device company Medtronic, [and] served as the national principal investigator in clinical tests of the device.”

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The release states that, “compared to other technologies, the stent graft can travel through smaller, curvy vessels and better adjust to a patient’s anatomy.”

The real question is: is that relevant?  Does this ability to travel through curvy vessels mean that the patients live longer and have fewer ruptures down the road?

We don’t know and the news release didn’t tell us.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

We are given no indication whether the procedure is in use in other hospitals outside the clinicians who were involved in the clinical trial.

Does the news release establish the true novelty of the approach?

Not Satisfactory

The release mentions that the stent is new, however, it fails to acknowledge that stents are already commonly used to treat aneurysms, particularly aneurysms of the aorta located in the abdomen. This stent may offer some advantages, perhaps for aneurysms higher up and closer to the heart where the aorta is curved, but the release doesn’t explicitly state that.

Total Score: 1 of 10 Satisfactory


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