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Under-Skin Defibrillators Seen Closer to Reality


5 Star

Under-Skin Defibrillators Seen Closer to Reality

Our Review Summary

This story includes an independent source and details about the underlying concept of the new device and its limitations that help readers put the research into the proper perspective. Aside from including more pertinent information, this story did a better job of characterizing the research report as one step in a long process.


Why This Matters

Until two treatments are directly compared, it is usually inappropriate to claim that one is superior to the other. This story does a good job of explaining the results of research into this new device without implying that the preliminary trials produced evidence it may be better than existing devices.


Does the story adequately discuss the costs of the intervention?


The story notes that the cost of the device would be similar to that of existing devices, but that implantation is simpler, which might make those costs lower. It would have been helpful to specify the estimated cost of existing implantable defibrillators.

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


This story outlines the problems with the electrical lead wires of existing devices that have harmed patients and required re-operations and recalls. It explains that by using wires placed under the skin, instead of through blood vessels into the heart, the new device might reduce the risks associated with implantable defibrillators for certain patients. The story cautions that only about a quarter of patients who currently are given implantable defibrillators might be candidates for the new type of device.

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

Not Satisfactory

Although the researchers pointed out in their journal article that “the initial experience includes several cases of problems such as lead migration, lead dislodgement, and inappropriate sensing,” the story does not refer to any potential harms.

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


In the lead, this story appropriately characterizes the new report as a step toward implantable defibrillators that do not have wires attached directly to the hearts of patients. It points out that much of the new data is based on the experiences of about 60 patients who had one of the new devices for a year. The story makes more than one reference to the need for further trials before the developers of the new device would have enough evidence to apply for FDA approval.

Does the story commit disease-mongering?


The story points out that the new device is intended for use in a subset of patients who are already considered candidates for conventional implantable defibrillators.

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


The story includes an independent source. It points out that the trials of the new device were paid for by the manufacturer and that the lead researcher founded the company.

Does the story compare the new approach with existing alternatives?


The story makes clear that, depending on the results of further trials, the new device could be an incremental improvement on existing implantable defibrillators for certain patients. It also notes that it does not offer the heart pacemaker function of some existing implantable defibrillators.

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


The story points out that the new type of implantable defibrillator is available in some countries in Europe, but that further trials are needed to produce evidence that could be used to apply for FDA approval in the United States.

Does the story establish the true novelty of the approach?


The story notes that the device has been under development for several years and requires further research before it can be considered for clinical use.

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: 9 of 10 Satisfactory


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