Biotronik wins FDA nod for Orsiro DES

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. Read the whole story on our sister site, Drug Delivery Business News The post Biotronik wins FDA nod for Orsiro DES appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Drug-Eluting Stents Food & Drug Administration (FDA) Regulatory/Compliance Biotronik Source Type: news