GE gets EMA clearance for Rapiscan stressor in FFR

By AuntMinnieEurope.com staff writers

January 29, 2019 -- GE Healthcare announced that the European Medicines Agency (EMA) has approved its Rapiscan (regadenoson) pharmacological stress agent for on-label use in measuring fractional flow reserve (FFR) to identify hemodynamically or functionally significant stenosis.

Specifically, Rapiscan is now indicated for the measurement of FFR of a single coronary artery stenosis during invasive coronary angiography when repeated FFR measurements are not anticipated, according to the vendor. The new indication is the second for Rapiscan; the agent was initially approved in 2010 for use in radionuclide myocardial perfusion studies.

Rapiscan for FFR will be available across Europe in 2019, GE said.


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