Stent and Deliver
This article was originally published in Start Up
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.
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Just as drug-eluting stents prevent heart attacks by maintaining the patency of coronary arteries, so do carotid artery stents prevent strokes by keeping carotid arteries open. Carotid artery stenting, like coronary stenting, is a minimally invasive, percutaneous procedure and both procedures use similar kinds of devices. The large cardiovascular device companies are all in clinical trials with carotid artery stents, but none is expected on the US market before 2005. Still, the market for carotids isn't likely to be nearly as big as that of coronary stents.
Innovative device companies have always had to contend with the Sword of Damocles of unexpected technological obsolescence, but for would-be developers of interventional devices for the prevention of restenosis, the sword is dangling perilously close. In the RAVEL trial, a 238-patient clinical trial on a drug eluting stent, treated patients experienced 0% restenosis compared to 26% in the control group. Now, device developers with alternatives to stents reposition themselves to sustain businesses in the face of potentially shrinking target markets. Many argue that they will serve certain applications better than stents; others hope to work with drug-coated stents to enhance performance, many believe that economics will leave room for alternative approaches, and still others are getting out of the coronary business entirely.