Abbott's Future as a Stent Maker

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Go ahead and call me a nerd, but I think reading FDA advisory panel briefing documents is kind of fun. It's not like they have exciting plot lines -- although in Dendreon's (Nasdaq: DNDN) case, they certainly did -- but it's interesting to get a sneak peek into the minds of FDA staffers via their executive summaries.

After reading the executive summary released yesterday for Abbott Laboratories' (NYSE: ABT) XIENCE V drug-eluting stent, I'd say the FDA seems pretty happy with the clinical trial data.

The pivotal phase 3 trial was set up so that the XIENCE stent only had to work as well as Boston Scientific's (NYSE: BSX) TAXUS Express 2 stent, but statistical analysis demonstrated that the XIENCE stent is actually better than the TAXUS stent at keeping the blood vessel from re-narrowing after about eight months.

Much of the safety data that the FDA required was kindly provided by Novartis (NYSE: NVS), since the drug part of the XIENCE drug-eluting stent shares the same active ingredient as Novartis' organ-transplant-rejection drug candidate, Certican.

The only real problem that the FDA has with the trials is that the complete two-year safety data isn't available yet. But the subjects that have had their stents in that long showed a reduced level of major adverse cardiac events, such as heart attacks. Even so, I think it's likely that the FDA advisory committee will likely give it a pass on the incomplete safety data and recommend the stent be approved at its meeting tomorrow.

Johnson & Johnson (NYSE: JNJ) and Boston Scientific need to keep an eye glued on their rearview mirrors; with a decision about Medtronic's (NYSE: MDT) stent expected shortly, as well as fine data from Abbott, the drug-eluting stent market is about to get pretty interesting.