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WASHINGTON (Reuters Health) – CardioVasc Inc. said on Monday that it has received the European Union's CE Mark for its NuVasc Stent Graft, which is aimed at lowering the rate of restenosis and thrombosis associated with older-generation grafts.
"An ePTFE sleeve treated with p-15, a patented cell adhesion peptide coating, 'covers' the stent and serves to protect the plaque material from releasing into the bloodstream," the privately-held US firm said. P-15 encourages rapid endothelial cell growth.
The NuVasc Stent Graft is indicated for the treatment of saphenous vein grafts that have failed after bypass surgeries, the company said, estimating that about 500,000 such operations are conducted worldwide each year and that the rate of subsequent graft failure is about 10% during the first year and 50% after 10 years.
Based on these figures, CardioVasc said its graft would have a potential patient pool in excess of one million people.
Clinical trials to support the graft's approval in the US are slated to begin in 2002.
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