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Home Industry News St Jude Medical begins enrolment for FFR trial

St Jude Medical begins enrolment for FFR trial

26th May 2010

St Jude Medical has commenced enrolment for a forthcoming clinical trial, which will gauge the effectiveness of Fractional Flow Reserve (FFR) technology in treating stable coronary artery disease.

The first patient has been enrolled for the Fame II study, which is to involve around 1,600 patients from Europe and the US and will evaluate the safety and efficacy of percutaneous coronary intervention guided by FFR plus optimal medical treatment (OMT), compared to OMT alone.

It will act as a follow-up to the St Jude-sponsored Fame trial, which demonstrated the superior performance of FFR-guided stenting compared to angiographic-guided stenting when treating multivessel coronary artery disease.

Frank Callaghan, president of the St Jude Medical cardiovascular division, said: “St Jude Medical is pleased to also sponsor the Fame II trial, which is an important next step to discovering the benefits of using FFR measurements in a new patient population.”

Last week, the company announced that it is to acquire LightLab Imaging, a provider of optical coherence tomography technology for high-quality coronary imaging.

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