FDA approves Orsiro drug-eluting stent (DES) system for treatment of coronary artery disease. Biotronik

Biotronik announced FDA approval of the Orsiro drug-eluting stent (DES) system. Orsiro is the first and only ultrathin DES to outperform the clinical standard, Xience. Orsiro received CE marking in 2011 and has been used to treat more than one million patients worldwide to date.

Orsiro�s unprecedented clinical performance in the BIOFLOW-V pivotal trial demonstrated significantly lower rates for target lesion failure (TLF) and target vessel myocardial infarction (MI) at 12 months in comparison to Xience in a large, complex patient population (n=1,344). At two years, treatment with Orsiro further improved event rates in comparison to Xience, including a significant reduction in target lesion revascularization (TLR) and spontaneous MI.

The two year results presented at TCT 2018 and published in the Journal of the American College of Cardiology show a 37 percent lower TLF rate in favor of Orsiro (7.5 percent versus 11.9 percent TLF rate, p-value=0.015), a 47 percent lower ischemia-driven TLR rate, and a 70 percent lower rate of spontaneous MI (landmark analysis 31 days to two years follow-up).

See- "TCT-707 A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Stent in the Treatment of Subjects with up to two de novo Coronary Artery Lesions � BIOFLOW IV: 3 Year Clinical Results". Ton Slagboom, Ralph Toelg, Bernhard Witzenbichler, Michael Haude, Monica Masotti, Rafael Jose Ruiz-Salmeron, Adam Witkowski, Ron Waksman, Shigeru Saito. Journal of the American College of Cardiology September 25, 2018, 72 (13 Supplement) B283; DOI: 10.1016/j.jacc.2018.08.192.4.