BIOTRONIK won FDA approval for its Orsiro drug-eluting coronary stent, an ultrathin device that’s already been approved in Europe for eight years and has been implanted in more than a million patients worldwide.
The Orsiro is a cobalt chromium metal stent that releases sirolimus, which helps to prevent restenosis. This is performed by BIOTRONIK’s proprietary BIOlute bioabsorbable polymer coating, which is infused with the drug and releases it as it breaks down.
The stent is available as narrow as 2.25 mm up to 4.0 mm in diameter and lengths up to 40 mm, which is the longest available in the U.S. for this kind of stent.
The approval was in part based on the BIOFLOW-V trial that, according to the company, “demonstrated significantly lower rates for target lesion failure (TLF) and target vessel myocardial infarction (MI) at 12 months in comparison to Xience [made by Abbott] in a large, complex patient population (n=1,344).” Additionally, compared to the Xience stent, the Orsiro led to fewer target lesion revascularizations and heart attacks.
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).
“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.”
Product page: Orsiro…