German medical devices maker Biotronik has secured approval from the US Food and Drug Administration (FDA) for the Orsiro drug-eluting stent (DES) system for the treatment of coronary artery disease.
Made of cobalt chromium metal, the Orsiro stent is designed to elute the sirolimus compound through the company’s bioabsorbable polymer coating called BIOlute.
The device is said to feature ultrathin stent struts. It is intended for use in percutaneous coronary intervention (PCI) procedures, and is available in 52 sizes ranging between 2.25mm and 4mm in diameter and lengths up to 40mm.
In the pivotal BIOFLOW-V clinical trial, the Orsiro stent led to significantly lower target lesion failure (TLF) and target vessel myocardial infarction (MI) rates, compared to Abbott’s Xience DES, at 12 months.
Orsiro demonstrated further improvements in event rates at two years, including a significant decrease in target lesion revascularization (TLR) and spontaneous MI, compared to Xience.
Biotronik president Ryan Walters said: “The FDA approval of Orsiro changes the dynamic of what had become a highly commoditized DES market. 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 lesions and challenging subgroups to achieve unprecedented patient outcomes.”
Orsiro secured the European CE-Mark clearance in 2011. The company has said that so far the stent has been used for the treatment of more than one million patients worldwide.
In September last year, Biotronik received the FDA approval for PK Papyrus Covered Stent in emergency acute coronary perforations treatment.
A balloon-expandable covered coronary stent, PK Papyrus is said to be the first FDA approved device for this indication in 17 years.