FDA Approves Orsiro Ultrathin-Strut Stent for CAD

Orsiro, an ultrathin-strut coronary stent, is now approved by the US Food and Drug Administration for the treatment of coronary artery disease, according to an announcement today from device maker Biotronik.

The FDA approval is based on data from BIOFLOW-V, a 1,334-patient study that showed the Orsiro device outperformed the Xience everolimus-eluting stent (Abbott Vascular). In that trial, as reported by TCTMD, the Orsiro stent was associated with a significantly lower rate of target lesion failure and target-vessel MI at 12 months when compared with Xience.

Orsiro, a cobalt-chromium metallic stent that elutes sirolimus via a bioresorbable polymer, has a strut thickness of just 60 µm for the devices with diameters of 2.25 and 3.0 mm. The stent will be available in 52 sizes, including diameters ranging from 2.25 to 4.0 mm and lengths up to 40 mm.

The Orsiro stent, which has been marketed in Europe since 2011, is the only so-called ultrathin-strut device approved in the US. In 2017, the FDA approved the EluNIR ridaforolimus-eluting stent (Cardinal Health/Medinol) for the treatment of patients with coronary artery disease. While the EluNIR stent is a made up of a combination of supportive struts ranging in widths, struts are relatively thick at 90 µm, which is similar to other commercially available stents.

Correction: This story has been corrected to reflect that Orsiro is the only ultrathin-strut stent available in the United States.

Photo Credit: Biotronik