February 21, 2019
FDA Approves Biotronik's Ultrathin Orsiro DES for the Treatment of Coronary Artery Disease
February 22, 2019—Biotronik announced FDA approval of the Orsiro drug-eluting stent (DES) system, which is now available commercially in the United States for use in percutaneous coronary intervention (PCI) procedures. The ultrathin Orsiro DES received European CE Mark approval in 2011.
According to the company, the cobalt chromium metal Orsiro stent elutes sirolimus via the company's Biolute bioabsorbable polymer coating. Beneath the bioabsorbable layer, there is Biotronik's ProBio passive coating on the bare-metal surface, which is designed to reduce nickel ion release. Biotronik stated that the Orsiro stent system provides ultrathin stent struts without compromising radial strength, and a low crossing profile for easier lesion cross in complex PCI. The Orsiro DES system is available in 52 sizes ranging from 2.25 to 4 mm in diameter and lengths up to 40 mm.
Orsiro's approval was supported by findings of the BIOFLOW-V pivotal trial. BIOFLOW-V demonstrated significantly lower rates for target lesion failure and target vessel myocardial infarction (MI) at 12 months versus the thin durable polymer Xience everolimus-eluting stent (Abbott Vascular) in a large, complex patient population (N = 1,344).
The 2-year data from the BIOFLOW-V were presented at TCT 2018, the 30th annual Transcatheter Cardiovascular Therapeutics scientific symposium held September 21–25 in San Diego, California, and published simultaneously online by David E. Kandzari, MD, et al in Journal of the American College of Cardiology.
Biotronik advised that in the study, treatment with Orsiro further improved event rates in comparison to Xience, including a significant reduction in target lesion revascularization (TLR) and spontaneous MI. At 2 years, Orsiro resulted in a 37% lower TLF rate (7.5% vs 11.9%; P = .015), a 47% lower ischemia-driven TLR rate, and a 70% lower rate of spontaneous MI (landmark analysis, 31 days to 2 years follow-up).
David Kandzari, MD, United States Principal Investigator for BIOFLOW-V, commented in the company's announcement, "Orsiro has set a new standard for safety and efficacy clinical endpoints, including statistically lower [TLR] and target vessel MI rates. BIOFLOW-V data are the best clinical outcomes witnessed with modern DESs. It was largely thought that efficacy findings were unsurpassable, but Orsiro proves we can further reduce event rates with meaningful innovation."