Too much company perspective, accompanied by no independent expert perspective makes this a one-sided story.
Based on the company’s press release, the study was a post marketing, open label study with no comparator arm. So the device was not compared directly with angioplasty or angioplasty and stent. According to the principal investigator, the results were comparable to those obtained in other studies using angioplasty and stent. But, there was no direct comparison made in the study and comparing results from two different studies is speculative at best. So, while there is an impression made that the Covidien device is “as good” as angioplasty and stent, that impression is not backed up by data. We are told that there is “no metal left behind” but the importance of that fact is left to the reader’s imagination.
Comparative cost of treatment, comparative harms and long term results are needed to determine if the device is going to live up to expectations.
A local story about a product from a local company (or one that has a “significant presence” locally) should still provide context on comparative costs, tradeoffs between benefits and harms, comparisons with other approaches, and independent perspectives. These were all lacking in this story.
No mention of costs of atherectomy nor of the tool in question.
No data were provided – only superlatives from the local company:
A company news release did provide more details on potential benefits.
No discussion of potential harms from the approach.
Any newly introduced device used in an interventional procedure has inherent risks both from the device itself and from the operator. The procedural complication rate is an important consideration especially since the new device is said to be as good as existing treatmemts.
No independent evaluation of the evidence. A study that the company cleverly named DEFINITIVE demands scrutiny to show how definitive it may or may not be.
No disease mongering of peripheral artery disease.
There were comments from the principal investigator – but they only addressed business prospects – not clinical efficacy questions And there was a stock analyst’s perspective.
But we expect more: independent clinical experts’ perspectives on what the data on harms and benefits mean for patients – especially when the headline claims “tools shown effective against PAD.”
There were company comments about qualitative differences among alternative approaches, but no real substantive discussion about comparative outcomes.
The story never established if the device is approved by the FDA, and, if so, how widely it is used and available. There’s a quote from the principal investigator that atherectomy is “only used in about 15-20% of PAD cases” but that he expects that to change with these results. But not all atherectomy is done with these tools. We actually aren’t told how many are done with these tools.
Following up on the point just made, there is no explanation of what makes this company’s tools different or novel in comparison with other atherectomy tools/approaches.
Although the story is filled with company perspectives, there’s no evidence it relied solely or largely on a news release. It did, though, appear to lift one paragraph from a company news release.
According to the American Heart Association, about 10 million people in the U.S. are affected by PAD, which can lead to heart attack, stroke, amputation and death. It occurs when arteries in the legs become narrowed or blocked by plaque. Blockages can result in severe pain, limited mobility and nonhealing leg ulcers.
According to the American Heart Association, approximately 10 million people in the U.S. are affected by PAD, which is one of the most common vascular diseases and can lead to heart attack, stroke, amputation and death. It occurs when arteries in the legs become narrowed or blocked by plaque; these blockages can result in severe pain for patients, limited physical mobility and non-healing leg ulcers.