FDA approves Promus Element Plus and Promus Premier coronary stent systems


The FDA has announced it has approved Boston Scientific’s Promus Element Plus and Promus Premier everolimus-eluting, platinum chromium coronary stent system (monorail and over-the-wire) systems. The FDA reports that both systems share similarities with already approved stent systems.

It says that the Promus Element Plus stent uses the identical drug coating formulation and drug dose density as the approved Promus/Xience (Boston Scientific/Abbott Vascular) and identical stent materials, stent design, and balloon materials as the approved ION stent (Boston Scientific), The FDA adds that Promus Premier system is very similar to the Promus Element Plus stent, but has additional metal connector wires in its structure. Due to the extra connectors on the stent, there is a very slight increase in the amount of drug on the Promus Premier stent.

According to the FDA, both stents are to be used in patients, including those with diabetes, who have narrowing in coronary arteries with length less than or equal to 34 mm with reference vessel diameters greater than or equal to 2.25 mm and less than or equal to 4.00 m