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Latest From Carmeda AB
The successful commercialization of drug-eluting stents (DES) has done much to pave the way for the biocoating industy. DES not only helped establish a new regulatory body to facilitate device-drug reviews, the FDA Office of Combination Products, they also proved that biocoated devices could take market share from uncoated products, command premium pricing and premium reimbursement.
Stents have been very effective at avoiding elastic recoil by mechanically holding arteries open after balloon angioplasty. They have also, to a certain extent, alleviated the problem of restenosis, the reocclusion of the artery in the months following angioplasty. Unfortunately, however, stents don't go far enough to prevent restenosis--anywhere from 10% to 40% of patients will develop restenosis within six months of revascularization procedures--and the devices frequently result in a new, man-made and difficult-to-treat kind of restenosis, known as in-stent restenosis. Thus, device developers are putting serious development effort into enhanced stents that can carry and deliver drugs to combat restenosis locally.