Boston Sci touts long-term safety of Promus stent, despite FDA warning

Over at EuroPCR in Paris, Boston Scientific ($BSX) unveiled the results of a two-year safety study on its Promus Element drug-eluting stents, boasting of "excellent" results for the device.

The stent, approved by the FDA last year, demonstrated low revascularization rates with no disruption of heart function or thrombosis, the company said. "These long-term results are impressive, especially considering the small vessel diameters that were evaluated in this study," co-principal investigator Ian Meredith said in a statement.

The positive results come after the FDA required Boston Sci to warn doctors about a rare but serious safety issue with Promus. The stents feature thin struts to allow for easier implantation into hard-to-reach arteries, but that property can also predispose them to longitudinal stent deformation, which can lead to clotting and heart attack. Promus wasn't the only stent with deformation risk--offerings from Abbott Laboratories ($ABT) and Medtronic ($MDT) did, too--but it was the only one required by the FDA to carry a warning label.

But Boston Sci, the largest manufacturer of stents, is confident in the device's safety, hence the high-profile announcement of the study results. And while the latest trials make no mention of deformation, the lack of reported heart attacks would seem to indicate that the company's large investment is on track.

- read Boston Sci's release