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Below-the-skin defibrillator restores heartbeat


4 Star

Below-the-skin defibrillator restores heartbeat

Our Review Summary

Readers are told that further trials are needed, but while key potential benefits of the new type of device are outlined, the story does not mention problems that the researchers encountered in these early trials. The most important missing element in this story is comment from a source who does not have financial or other ties to the research or device manufacturer.


Why This Matters

While it would have been helpful to name a dollar figure, the story did say that the new device costs roughly the same as existing implantable defibrillators. However, the story also includes claims that associated costs will be lower and complications fewer than with conventional devices, even though these claims have yet to be tested.

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


The story says that it is hoped the new device may be as effective as existing devices while potentially reducing the difficulty, risks and costs of implantation.

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

Not Satisfactory

The story mentions some harms, but only in quotes from the device developer that tend to minimize the risks and complications. The journal article summarizing the trials of the new device stated that “the initial experience includes several cases of problems such as lead migration, lead dislodgement, and inappropriate sensing.” These harms were not mentioned in the story.

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

Not Satisfactory

Although this story does point out at the end that “a larger study will be needed to prove that the device is as good as conventional implantable defibrillators,” the lead paragraph states that the techniques used by the new device “may be safer, and just as effective” as the conventional technique, implying a direct comparison that has not yet been performed.

The story does note that the journal article about the device is based on two “small” studies and that “long-term use was tested in 61 volunteers.”

Does the story commit disease-mongering?


The story presents the new device as a potential improvement on existing implantable defibrillators that would be used for the same sort of patients who are already considered candidates for treatment with conventional devices.

However, one quote from the doctor who developed the new device implies that it may be appropriate for at least 200,000 Americans each year. This figure appears to be higher than those quoted by other sources.

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

Not Satisfactory

The story did point out that the trials of the new device were paid for by the company developing it and that the lead researcher founded the company. However, the story does not include any comments from independent sources.

Does the story compare the new approach with existing alternatives?


It is clear in the story that the new device is intended as an improvement on existing implantable defibrillators. However, the story does not mention that the new device would not be appropriate for many patients who currently receive conventional implantable defibrillators.

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


The story points out that this new device is available in Europe, but has not been compared directly to existing devices and is not approved for regular use in the United States.

Does the story establish the true novelty of the approach?


The story makes clear that this new device is intended to be an incremental improvement on current devices and that it has been under development for several years.

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


The story does not appear to rely on a news release.

Total Score: 7 of 10 Satisfactory


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