Positive results from BIOFLOW-II clinical trial

Jun 04, 2013

Primary endpoint results, demonstrating the non-inferiority of the BIOTRONIK Orsiro hybrid drug-eluting stent compared to Abbott?s XIENCE PRIME, from the BIOFLOW-II clinical study have been revealed at the EuroPCR congress in Paris.

Primary endpoint results, demonstrating the non-inferiority of the BIOTRONIK Orsiro hybrid drug-eluting stent compared to Abbott's XIENCE PRIME, from the BIOFLOW-II clinical study have been revealed at the EuroPCR congress in Paris.

The results were presented by Dr Stephan Windecker (University of Bern, Switzerland) and showed that the Orsiro met the primary endpoint of in-stent late lumen loss at 9 months, which equals that of the XIENCE PRIME. "The Orsiro stent met the primary non-inferiority endpoint of late loss at 9 months compared to the XIENCE PRIME stent, demonstrating effectiveness of drug elution from this bioabsorbable polymer," said Dr Windecker. "The platform also appears to be safe, with low rates of myocardial infarction and revascularization and no reported stent thrombosis."

In addition to these results, the primary endpoint results from the BIOFLOW-III registry were also presented by Professor Johannes Waltenberger (Universitätsklinikum Münster, Germany). The 12 month BIOFLOW-III results demonstrated the safety and efficacy of the stent in a larger and more complex patient population, according to Prof. Waltenberger.

Further information may be found here.

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