Boston Completes Enrollment In Pivotal Workhorse Trial

Boston Scientific has completed patient enrollment in the workhorse portion of its PLATINUM clinical program. The trial enrolled 1,532 patients with up to two de novo lesions at more than 140 sites, and completed enrollment two months ahead of schedule.

The company claims that PLATINUM is a randomised, pivotal controlled trial designed to support US FDA and Japanese Ministry of Health, Labor and Welfare (MHLW) approval of the platinum chromium PROMUS Element Everolimus-Eluting Coronary Stent System.

According to the company, PLATINUM workhorse trial evaluates the new PROMUS Element Everolimus-Eluting Coronary Stent in comparison with the current PROMUS Stent, which uses the same drug dose and polymer on an earlier cobalt chromium alloy stent design. Two parallel sub-trials will evaluate the PROMUS Element Stent in small vessels and long lesions.

Besides, the PROMUS Element Everolimus-Eluting Stent, the company stated to develop additional variations of a bare-metal and paclitaxel-eluting stent on the Element platform. The pivotal PERSEUS clinical trial compares the TAXUS Element Stent to the TAXUS Express2 Stent. .

Hank Kucheman, group president and senior vice president of cardiovascular for Boston Scientific, said: “We are pleased to bring the next-generation Element drug-eluting stent platform another step closer to commercialisation. We are confident that the next-generation Element platform – to be offered in everolimus, paclitaxel and bare-metal versions – will further extend our global drug-eluting stent leadership.”