J&J's drug-eluting stent Cypher approved for CAD patients in USA

Johnson & Johnson's medical device subsidiary, Cordis, has been grantedmarketing approval for its Cypher drug-eluting stent in the USA. The clearance by the US Food and Drug Administration follows the registration and launch of the device in Europe (Marketletters passim).

Cypher, which is coated with Wyeth's immunosuppressant compound sirolimus and has been shown to reduce in-stent restenosis by a whopping 91% and in-segment restenosis by 75% in the recently-announced SIRIUS trial, is already approved in Europe and marketed in more than 50 countries worldwide. However, the US market is seen as the most lucrative for the device, as the use of stents tends to be higher in that country than elsewhere.

The product becomes the first drug-eluting stent to be approved by the FDA, giving Cordis a lead over rival stents from Boston Scientific, Guidant, Medtronic and Abbott Laboratories in what promises to be a rapidly-growing market. There have been suggestions that the advent of drug-eluting stents will double the size of the overall market for these products to $5 billion, with analysts predicting that Cypher could achieve sales of $3 billion in its peak year.