Boston Scientific begins enrolment for Taxus stent trial

Boston Scientific has announced the commencement of enrolment for a new clinical study of its Taxus paclitaxel-eluting platinum chromium coronary stent system.

The first patients have been recruited for the new Omega trial, evaluating the safety and efficacy of the medical device in treating single coronary artery lesions, with 328 subjects set to be enrolled across the US and Europe.

Boston Scientific's primary endpoint for the study is improved rates of nine-month target lesion failure, a composite measure that encompasses target lesion revascularisation, myocardial infarction and cardiac death.

The Taxus device received CE Mark approval earlier this year, with this current study aimed at supporting its approval in the US, where it would be sold under the brand name Omega.

Dr Keith Dawkins, senior vice-president and chief medical officer for Boston Scientific's cardiology, rhythm and vascular division, said: "Our platinum chromium drug-eluting stents have been well-received by physicians in approved markets and we look forward to offering a bare-metal stent in the US built on the same advanced platform."

This comes after the firm also began enrolment for a new study of vagal nerve stimulation techniques for heart failure last week.