With the filing by Guidant Corp. of a PMA requesting FDA approval for the use of its coronary artery stent in restenosis, the US stent market is moving one step closer to an all-out battle. Currently, Johnson & Johnson 's Palmaz-Schatz stent has 90% share in the US, where it faces competition only from Cook Group Inc. , whose GR-II is a niche product with a limited indication. The approval of Guidant's Multi-Link, which could come late this year or early next year, is likely to create a whole new ball game. The Multi-Link, which is doing extremely well in Europe, is expected to be the first head-to-head competitor J&J faces in the US. And a strong opponent it will be: the Multi-Link's easier-to-use delivery system, combined with the marketing strength of its maker, has helped it capture the number three position in Europe, say analysts. (Guidant says it is number one in Europe in terms of units, with around 20% market share, despite a recall in France.) Medtronic Inc. just received FDA approval of its Wiktor stent, but only for limited applications.
The big question is what J&J intends to do about defending its patents in the US. Based on the settlement...
