Fresh off positive safety data, Boston Scientific ($BSX) has secured FDA approval for two new lengths of its Promus Element stent. The agency OK'd the 32 mm and 38 mm lengths of the drug-eluting stent, which is designed to treat coronary artery disease.
Last month, at the EuroPCR conference, Boston Sci unveiled the results of a two-year safety study of Element, demonstrating no evidence of heart function disruption or thrombosis. While the device has been FDA-approved since 2011, the agency required Boston Sci to package it with a warning label after a rare, but serious, safety issue came up during trials. The stent's thin struts allow it to reach narrow passages, but they also present a risk of longitudinal stent deformation, which can lead to heart failure and clotting.
However, Boston Sci has that in the rearview with its new approved stent lengths, which the company says will only help expand its market share. "This latest regulatory approval...marks yet another important milestone for Boston Scientific--we now offer the market-leading everolimus drug on our (platinum chromium) stent platform in the broadest range of lengths and diameters in the United States," said Kevin Ballinger, president of Boston Scientific's cardiovascular division, in a statement.
All this comes as device giants continue to angle for dominance in the stent market through new indications, lengths and safety studies. Medtronic ($MDT) recently announced 7 new indications for its Resolute Integrity stent, and Abbott Laboratories ($ABT) is touting a new CE mark that clears its Xience stents for dual anti-platelet therapy.
- read Boston Scientific's release