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March 5, 2007 -- 11:53pm EST

Dueling Thromboses
We're talking thromboses or blood clots -- and oddly enough the same day that Vice-President Cheney was diagnosed with a thrombosis, specifically a deep venous thrombosis (DVT) in his leg, Representative Henry Waxman announced he had sent a letter, on behalf of the House Committee on Oversight and Government Reform, to the two drug-eluting stent manufacturers, Boston Scientific and Cordis, to deliver information to his Committee about late stent thrombosis and their DES marketing strategies.

Adding to this coincidence of events in Washington is Wednesday's "Workshop With The FDA" session at the CRT 2007 meeting, run by Dr. Ron Waksman (not Waxman) of the Washington Hospital Center. This all-day session will bring together a wide variety of industry, government and physicians to hash out the issues surrounding late stent thrombosis in drug-eluting stents.

And the clinical issues are complex -- it will be interesting to see what a Congressional Committee is able to come up with in this area, since the large inclusive panel of experts that the FDA convened in December felt there wasn't enough solid data to make a definitive statement about "off-label" use of DES, other than a recommendation for longer clopidogrel therapy, more care in patient selection and more study of the incidence of late stent thrombosis.

As for the marketing issues -- this information has not been aired much before. Stay tuned....

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