Friday, July 04, 2008

ANOTHER DES GETS FDA APPROVAL

The FDA today formally approved the Xience V stent by Abbott Vascular and also Promus by Boston Scientific, for sale in USA. The Promus stent is the twin sister of Xience V. They are identical DES, one marketed by Abbott Vascular and the other by Boston Sc.. This was a result of the agreement made when Abbott help finance the buyout of Guidant by Boston Sc.. There is now a marketing arrangement whereby Boston Sc will pay Abbott royalty for every Promus sold. But of course, it allows Boston to have a fast track to getting a "limus " DES. Last November, the FDA advisory panel recommended the approval of Xience V, but I think the FDA awaited the full 2 years result of the Spirit 2 study by Abbott, presented by Dr Greg Stone at EuroPCR in May, before formally approving it today. The Xience V stent is a good, second generation DES, on a very deliverable system. This cobalt chromium stent is very strong, and very thin strut. I have used quite a few of them and they are good. There is a low incidence of repeat TLR ( target lesion revascularisation ) and also, I do not believe that I have any stent thrombosis on this stent. Well, of course my hope is that with 4 stents available in the US market now, the cost of DES will come down in US and hopefully, also in Malaysia. This will be good for patients and also good for Abbott Malaysia, as they will have to lower price, I think, to be able to compete with the Chinese DES that will soon be available to the Malaysian market. Well, market competition remains the surest way of giving the best deal for the consumer. Looks like we have finally exocised the evils of DES, with these two DES approved now and the Endeavor DES approval in early 2008. We may have finally put to rest, the ghost of Barcelona Sept 2006, when all the evils of DES was splash across all major newspapers, worldwide.

No comments: