The Perseus clinical program has enrolled nearly 1,500 patients at 100 US and international centers since July 2007, and will compare the Taxus Element stent to the prior-generation Taxus Express2 stent marketed in the US since 2004. The company plans to develop additional versions of the Element platform, including next generations of a bare-metal stent and an everolimus-eluting Promus Element stent system.
The Taxus Perseus clinical program will evaluate the efficacy and safety of the Taxus Element Stent in two studies. The first study, Taxus Perseus Workhorse, will evaluate the safety and efficacy of the Taxus Element stent compared to Boston Scientific’s first generation drug-eluting stent, the Taxus Express stent.
This 3:1 randomized study will evaluate 1,264 patients from 94 sites in the US, Australia, New Zealand and Singapore with ‘workhorse’ lesions from 2.75 to 4mm in diameter. The primary endpoint of the workhorse study is target lesion failure (TLF) at 12 months, and its secondary endpoint is in-segment percent diameter stenosis at nine months.
A second parallel study named the Taxus Perseus small vessel study will compare the Taxus Element stent to a historic control. This study will include 224 patients from 35 US sites with lesions from 2.25 up to 2.7mm. The primary endpoint of the small vessel study is in-stent late loss at nine months, and its secondary endpoint is TLF at 12 months.
The Taxus Element stent is an investigational device and is limited by federal law to investigational use only and is not available for sale. Boston Scientific is currently seeking CE Mark approval in European markets, which is anticipated in 2009.