FDA approves Orsiro stent for coronary artery disease


The Food and Drug Administration has approved Orsiro, an ultrathin drug-eluting stent (DES), for the treatment of coronary artery disease.

FDA icon Wikimedia Commons/FitzColinGerald/Creative Commons License

FDA approval was based on 2-year results from BIOFLOW-V, an international, randomized trial in 1,344 patients with coronary artery disease who received either Orsiro or Xience, the current clinical standard. At 2 years, patients who received Orsiro had a 37% lower target lesion failure rate, a 47% lower ischemia-driven target lesion revascularization rate, and a 70% lower spontaneous MI rate. These results were published in the Journal of the American College of Cardiology and presented at the Transcatheter Cardiovascular Therapeutics annual meeting in November 2018.

Orsiro previously received CE marking in Europe in 2011 and has been used to treat more than 1 million patients. The device elutes sirolimus and is available in 52 sizes ranging from 2.25 to 4.0 mm in diameter and lengths up to 40 mm, according to Biotronik’s press release.

“Orsiro has set a new standard for safety and efficacy clinical endpoints, including statistically lower target lesion revascularization and target vessel MI rates. 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,” David Kandzari, MD, a cardiologist at Piedmont Heart Institute in Atlanta and principal U.S. investigator for BIOFLOW-V, said in the press release.

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