FDA Approves BIOTRONIK’s Ultrathin Orsiro Stent for the Treatment of Coronary Artery Disease
Orsiro Achieves Statistically Lower Clinical Event Rates and Superior Patient Outcomes
BIOTRONIK today 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.1,2 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)3.
“Orsiro has set a new standard for safety and efficacy clinical endpoints, including statistically lower target lesion revascularization and target vessel MI rates,” said Dr. David Kandzari, BIOFLOW-V US principal investigator, Piedmont Heart Institute, Atlanta. “BIOFLOW-V data are the best clinical outcomes witnessed with modern DES. It was largely thought that efficacy findings were unsurpassable, but Orsiro proves we can further reduce event rates with meaningful innovation.”
For use in percutaneous coronary intervention (PCI) procedures, the cobalt chromium metal stent elutes sirolimus via BIOluteTM, BIOTRONIK’s bioabsorbable polymer coating. Beneath the bioabsorbable layer is BIOTRONIK’s proBIOTM, a passive coating on the bare metal surface, designed to reduce nickel ion release. The Orsiro stent system provides ultrathin stent struts without compromising radial strength, and a low crossing profile for easier lesion cross in complex PCI4. It is available in 52 sizes ranging from 2.25 to 4.0 mm in diameter and lengths up to 40 mm, the longest available in the United States5.
“The FDA approval of Orsiro changes the dynamic of what had become a highly commoditized DES market,” said Ryan Walters, President at BIOTRONIK, Inc. “We designed Orsiro for use even in challenging cases with features that make it unlike any other DES in the world. Hospital administrators now have available a DES that shows improved clinical event rates and interventionalists can rely on Orsiro’s deliverability to treat complex lesions6 and challenging subgroups to achieve unprecedented patient outcomes. Patients, physicians and health systems deserve the best, and that is exactly what we are bringing to the US market.”
Orsiro is now commercially available in the US.
1. Xience is a trademark or registered trademark of Abbott Cardiovascular Systems.
2. Kandzari D et al. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. The Lancet 390.10105 (2017): 843-1852.
4. BIOTRONIK data on file.
5. As per IFU.
6. Orsiro is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation myocardial infarction or documented silent ischemia due to atherosclerotic lesions in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm and lesion length of ≤ 36 mm.
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.