WHO: Greg Chapman, M.D., director of interventional cardiology at UAB and lead investigator of UAB's portion of the SIRIUS clinical trial, is available to discuss today's FDA approval of Cordis' drug-coated stent for the treatment of blocked coronary arteries.
WHAT: The CYPHER Sirolimus-eluting Coronary Stent is the first drug-coated stent to receive marketing approval from the Food and Drug Administration (FDA) for the treatment of blocked coronary arteries.
Cardiovascular stents are tiny, metal scaffolding-like structures used to prop open clogged heart vessels. The new CYPHER stent was developed to address the problem of in-stent restenosis, or reblockage, which occurs in as many as 30 percent of patients who receive a bare metal stent. The new stent is coated with the drug sirolimus, which is slowly released into the vessel lining to prevent scar tissue growth through the openings in the stent mesh, which frequently leads to restenosis.
RESULTS: Results of large-scale studies involving nearly 1,400 patients worldwide, and which UAB participated in, show that the CYPHER stent, manufactured by Cordis Corp., a Johnson & Johnson company, reduces the incidence of restenosis by more than 90 percent when compared with a bare metal stent.
AT UAB: Nearly 1,600 stenting procedures are performed annually at UAB and the availability of the new stent is expected to generate widespread interest. Currently, the stent is only approved for blockages in smaller vessels -- 2.5 to 3 mm -- where restenosis is more likely to occur. Chapman says the approval may provide patients with smaller blockages new treatment options who might otherwise have only been treated with medications in the past.
RSS