Healthcare Business

Stent Safety Issues at the FDA....Hogwash

Douglas A. McIntyre


The FDA review of stents should not change the current practice, and that is for drug coated and uncoated stents.  If it does then the FDA is saying that having a heart attack is better than trying to prevent a heart attack.  No one can tell you 100% that the FDA will go ahead and keep these on the markets as is because we are afterall dealing with the FDA, but the benefits are too huge to keep them out of the market.

Boston Scientific (BSX) presented that the TAXUS drug coated stents are just as safe as bare metal stents already.  It also noted that TAXUS stents are far more effective in keeping arteries open and reducing the need for repeat procedures.  Johnson & Johnson (JNJ) has also said there is no significant difference in clotting, heart attack or death rates between its CYPHER stent and bare metal versions.

Multiple studies have suggested the risk of blood clots, heart attack and death rises in patients who stop taking Plavix earlier than now recommended.  The FDA believes patients could face a small but significant chance of blood clots, the question is to what extent are the risks compared to the benefits.

Medtronic (MDT) and Abbott (ABT) are both developing new stents, so this is farther reaching down the road than just the few companies alone.  Also, Angiotech (ANPI) is the maker of BSX’s polymer and SurModics (SRDX) is J&J’s polymer maker.  Conor Medsystems (CONR) is also currently under a takeover deal by J&J.

Bristol-Myers Squibb (BMY) & Sanfi-Aventis (SNY) make Plavix, the most common blood thinner used by people that have had stent surgeries.

The companies (BSX & JNJ) were presenting data, and consumer comments and panel questions will be today and tomorrow morning.  The FDA panel vote on recommendations is expected to take place tomorrow afternoon, and if for some reason they do anything other than recommend that blood thinners should be used for longer periods then they need their heads examined.

Insurance companies are probably watching this quite closely too because if the FDA says all of a sudden that drug coated stents are not worth the added efforts, then it will be the insurers paying for extra heart surgeries down the road.

If I ever need a stent myself, I will be looking to get the drug coated stents hands down and with no questions asked.  These prevent restinosis far better than bare metal stents and if there is a small added risk of clotting it is still worth it.   

Jon C. Ogg
December 7, 2006