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Patients May Benefit From New Heart Device


4 Star

Patients May Benefit From New Heart Device

Our Review Summary

This is a reasonably well written story about the impending release of data on a new medical device. The news of the soon-to-be released study might have specific interest for investors in Abbott or those in the medical device industry. For the rest of us, however, little of value could actually be discerned from the story other than that Abbott is about to present data.


Why This Matters

The pace of innovation in the interventional management of coronary artery disease has been impressive. First generation interventions included balloon angioplasty, quickly followed by angioplasty and placement of a stent to hold the vessel open. The third generation was heralded with the introduction of drug eluting stents. In each case, new technology was developed in response to what was perceived to be the failings of the existing approach. So, it is not surprising that a bioabsorbable stent would represent the fourth generation intervention. While the forthcoming case series mentioned in this story will add to previous data suggesting benefits from this new approach, only a randomized trial comparing a bioabsorbable and non-bioabsorbable stents will provide convincing evidence of its value.


Does the story adequately discuss the costs of the intervention?


We were happy to see some attention to the potential cost of the stent and in comparison to the existing drug eluting stents. In addition, the story provided information on the market size at the present time.

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

Not Satisfactory

The story really does not provide a crisp rationale for a bioabsorbable stent. An important limitation of existing stents is that they are associated with increased risk of clots. The absorbable stents are designed to help with this problem, but the story doesn’t communicate this. It only refers to the possibility that the new stents may also cause clots in some people. The comments of the Abbott spokesperson aside, the reader is not provided with any idea of how often the existing stents create difficulties and why the Abbott stent will alleviate the problem.

Does the story adequately explain/quantify the harms of the intervention?


We liked the fact that the potential downsides of the bioabsorbable stent were included in the story. The story notes that the bioabsorbable stent is thicker and may require patients to be on potent anti-clotting drugs, thus exposing the patient to a risk of bleeding. The story also notes that previous studies have shown a low rate of complications. We would have liked to have seen some information about the complications seen.

Does the story seem to grasp the quality of the evidence?


The results of the latest study examining the bioabsorbable stent haven’t yet been released, and the story does not delve into optimistic speculation about what the study may show.  We liked the way in which the theoretical advantages are stated and that the many unknowns and questions that remain are included. The story could have provided a bit more information on the previous studies of bioabsorble stents that are alluded to in the story, especially since there are no new data to discuss.

Does the story commit disease-mongering?


There was no disease-mongering in the story.

Does the story use independent sources and identify conflicts of interest?


The statements made by a company representative are counterbalanced by comments from Dr. Virmani, an independent expert in coronary artery disease and a very outspoken individual.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

We would have liked to have a comment or two on the parallel developments ongoing in this field. Coronary artery disease is more than a singe blockage. It is a systemic disease that is progressive unless systemic interventions are employed. Aggressive medical therapy is now viewed as an essential element to ongoing care and should have been included for completeness

Does the story establish the availability of the treatment/test/product/procedure?


The story makes it clear that while the absorbable stent is available in Europe, Abbot will not be seeking approval for marketing in the United States until 2015.

Does the story establish the true novelty of the approach?

Not Satisfactory

The idea of a bioabsorbable stent is not new or unique to Abbott. The concept was proposed in the early 1990’s and the other players are also working on their own version. Although the story alludes to the fact that competitors might seek to follow Abbott’s lead, it doesn’t convey that other companies are already quite far along in their research.

Does the story appear to rely solely or largely on a news release?


Since the story quotes an unaffiliated expert in the field of cardiac pathophysiology, it is clear that it did not rely solely on a press release. We do wonder, however, why the story ran prior to the issuance of the preliminary results on the new study.

Total Score: 7 of 10 Satisfactory


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