US EditionHighLife granted US FDA breakthrough designation for TMVR system - Cardiovascular News
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HighLife granted US FDA breakthrough designation for TMVR system - Cardiovascular News
HighLife SAS has announced that that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its transseptal mitral valve replacement (TMVR) system to treat patients suffering from moderate to severe mitral regurgitation (MR). The FDA’s breakthrough device programme is designed to speed up the development and review of devices that offer substantial improvement over current treatments or diagnostics for serious …
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