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Stents: Medicare Responds
to Wall Street Journal Article about Restrictions on Drug-Eluting
Stents |
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February 6, 2007 -- "I think the Wall Street Journal misunderstood whomever they were talking to," CMS Capital Markets Advisor Lambert Van der Walde told Angioplasty.Org this morning. Mr. Van der Walde was responding to today's Wall Street Journal report that the Centers for Medicare & Medicaid Services (CMS) was considering restricting its coverage of drug-eluting (a.k.a. coated) coronary stents because of "safety concerns." A similar report appeared later this morning from Bloomberg News. Mr. Van der Walde continued:
Such a change would be a radical blow to the medical device industry. According to the Wall Street Journal, "an agency spokesman" said that "such a process could result in restricting coverage of the stents to FDA-approved uses". Since 60% of drug-eluting stents are used in so-called "off-label" cases, elimination of such coverage would have profound effects throughout healthcare world, not just to the devices currently on the U.S. market, manufactured by Boston Scientific and Johnson & Johnson / Cordis, but to second and third generation stents that are on the horizon. In December, the FDA convened a special meeting, hearing from a broad international spectrum of industry representatives, cardiologists, surgeons and patient advocates in order to determine whether to change its labelling for drug-coated stents and whether or not there was a significant increased risk of blood clots in these devices. The panel judged that there was no increased risk when used for "on-label" approved indications. When asked to vote on "off-label" uses, the panel was divided -- the bottom line was that there probably is a slightly elevated risk of stent thrombosis in these more complex patients, but that there was not sufficient data to verify to what extent this translated to worse outcomes in these patients who already had more advanced disease. Critics on the panel were very concerned about the lack of data. Proponents of the coated stents pointed to the benefits of reducing restenosis, which can cause heart attacks, saying that any slightly increased blood clot risk was offset by the device's benefits.
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