FDA panel to review Abbot's coated stent

Will Johnson & Johnson and Boston Scientific soon have even more competition in the drug-coated stent market? The FDA has called an advisory committee meeting to review data on Abbott Laboratories' Xience stent late this month. You'll recall that Abbott released data last month that showed its stent in a favorable light compared with Boston Scientific's--more than 40 percent better, in fact. According to the study, patients with the Xience stent developed 43 percent fewer complications than those with Boston's Taxus stent.

Drug-eluting stents have spawned a whirlwind of warring studies ever since researchers concluded last year that the tiny devices might cause deadly blood clots. The bottom fell out of the market after those risks were reported, but some recent studies have shown that the drug-coated stents are actually more effective and less risky in some patients than bare ones are.

Speaking of data, some industry analysts are skeptical that Abbott will have enough to persuade the FDA committee that Xience is ready for prime time. When Medtronic got the panel's thumbs up last month for its drug-coated Endeavor stent, it had longer-term figures than Abbott does, they say.

Abbott's hoping to get the device to market by the first half of 2008, hard on the heels of Medtronic's Endeavor which is expected to hit by year's end. Whether Abbott will meet its goal depends, of course, on what happens at the Nov. 29 meeting.

- see the release from Abbott
- check out the CNN Money report
- read an analysis of Abbott's fortunes and Xience's potential effect

Related Articles:
Study: Coated stents aren't cost-effective. Report
Little common ground in stent controversy. Report
Tough times for stent market. Report
Congress spotlights J&J stent ops. Report
Medical device makers to fund stent safety study. Report
Decline in drug-coated stent use at cardiac centers. Report

Suggested Articles

Imbruvica has enjoyed a nice run in previously untreated CLL over the last few years. But major competition is here in the form of AZ's Calquence.

Pennsylvania's Supreme Court revived thousands of lawsuits alleging the antipsychotic med Risperdal caused males to develop breasts.

In the asthma biologics race, there doesn't appear to be a clear favorite among Xolair, Dupixent, Fasenra and Nucala for a group of pulmonologists.