Biotronik said today that it won FDA approval for its for its Orsiro drug-eluting stent, touting it as the first and only ultrathin DES to outperform Abbott‘s (NYSE:ABT) Xience.
The Berlin, Germany-based company said that the approval came based on data from the BIOFLOW-V pivotal trial of the device. Results from the study indicated a significantly lower rate for target lesion failure and target vessel myocardial infarction at 12 months as compared to Xience in a large, complex patient audience.
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The post Biotronik wins FDA nod for Orsiro DES appeared first on MassDevice.
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