Boston Scientific has reported positive results from the prospective, single-arm, sub trial of the PLATINUM clinical program - PLATINUM Small Vessel study, in which the 2.25 mm PROMUS Element Everolimus-Eluting Platinum Chromium Stent System has demonstrated safety and effective outcomes in treating small vessel coronary disease.
The PROMUS Element Stent System, which features a PtCr alloy, is designed for improved conformability, minimal recoil and uniform lesion coverage and drug distribution.
The study compared the PROMUS Element Stent (2.25 mm) in 94 patients with small vessels (greater than or equal to 2.25 to less than 2.50 mm reference vessel diameter and less than or equal to 28 mm lesion length) to a pre-specified performance goal based on results from patients treated with the TAXUS Express Paclitaxel-Eluting Stent.
The PLATINUM Small Vessel study met its primary endpoint of target lesion failure (TLF) at 12 months with a rate of 2.4% for the 2.25 mm PROMUS Element Stent in the per protocol population compared to a pre-specified performance goal of 21.1% (p<0.001) based on historical outcomes for the 2.25 mm TAXUS Express Stent.
The stent system received CE mark approval and was launched in Europe and other international markets in 2009.
Boston Scientific anticipates the US Food and Drug Administration approval for the PROMUS Element Stent, including the 2.25 mm PROMUS Element Stent, in mid 2012.