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Home Industry News St Jude Medical to halt enrolment for FFR trial based on positive data

St Jude Medical to halt enrolment for FFR trial based on positive data

23rd January 2012

St Jude Medical is set to cease enrolment for an ongoing clinical trial assessing the benefits of fractional flow reserve (FFR)-guided assessment for coronary artery disease patients, based on positive interim data.

The independent data safety monitoring board for the Fame II trial has recommended the move after the new treatment technique was shown to provide a highly significant reduction in the need for hospital readmission and urgent revascularisation.

As a result, it would now be considered unethical to continue placing patients in the control group, which would mean they would be receiving optimal medical therapy alone rather than the demonstrably beneficial FFR-based therapy.

The new technique is measured using St Jude Medical's PressureWire Aeris and PressureWire Certus devices and has already been shown in a previous study to improve outcomes in patients with stable coronary artery disease and two or three vessel disease.

Frank Callaghan, president of the St Jude Medical cardiovascular division, said: "This is further evidence that FFR should be considered the standard of care for patients with coronary artery disease."

This follows the publication of data from a St Jude Medical study earlier this month showing the benefits of implantable device monitoring for measuring stroke risks.ADNFCR-8000103-ID-801271952-ADNFCR

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