ESC Congress 2017: BIOTRONIK’s Orsiro Drug-Eluting Stent Outperforms Xience in BIOFLOW-V Trial
Landmark Data Published by The Lancet Demonstrates Statistically Significant Lower Event Rates with Orsiro
BIOTRONIK today announced data from the BIOFLOW-V randomized trial comparing Orsiro1 and Xience2 drug-eluting stents (DES) with 12-month target lesion failure (TLF) as the primary endpoint proving non-inferiority. Results presented at the European Society of Cardiology’s ESC Congress 2017 and published by The Lancet show 6.2 percent versus 9.6 percent 12-month TLF rate, demonstrating statistically significant improved clinical outcomes with Orsiro in percutaneous coronary intervention (PCI).
This pivotal US investigational device exemption (IDE) trial included a large, complex patient population and was designed in collaboration with the FDA to support an upcoming premarket approval submission. Orsiro is currently commercially available in more than 100 countries worldwide.
1 CAUTION – Investigational device in the United States. Limited by US law to investigational use.
2 Xience is a registered trademark of Abbott Cardiovascular Systems.
3 Not currently available in the United States.
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.