A while back THCB reported that there were some murmurs about problems with Boston Scientific’s Taxus stent. That followed earlier manufacturing problems with J&J’s Cypher stent. Now Boston Scientific has recalled about 200 stents with manufacturing defects.
This is probably a very minor hiccup in what has been a stellarly successful product launch. The Drug Eluting Stent (DES), which is on the way to being a $5bn market, has grown very fast to replace the bare-metal stent as a treatment of choice. This transition has helped over shadow research that showed that bare-metal stents (and the TCPA that accompanies them) were not as effective as by-pass surgery. Of course there are as yet no long term studies of the impact of re-stenosis from the new DES–but cardiologists and their suppliers have carried the day, and the drug-eluting stent (which incidentally is beginning to really negatively impact hospitals’ bottom lines) is the latest and greatest thing to hit interventional cardiology in ages. That’s a typical evolution of medical technology–put into mass use before it’s proved cost-effective compared to other treatment largely on implied promise. That’s the way health care works, and three decades of technology assessment work hasn’t changed it, and isn’t likely to soon. And minor manufacturing quality issues, if handled properly, won’t make any difference to that process.