GE gets EMA clearance for Rapiscan stressor in FFR

2017 12 15 22 08 5117 Ge Rsna 2017 400

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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