Long-Term Data for Biotronik’s Orsiro DES Holds Up

Biotronik is solidifying the Orsiro Drug-Eluting Stents position in the market with favorable five-year data. The Lake Oswego, OR-based company presented data from the BIOFLOW-V trial at the 2022 CRT Conference.

Biotronik won FDA approval for the Orsiro in February of 2019 and had CE mark for the device since 2011.

The company said the five-year follow-up data demonstrates consistently lower clinical event rates in target lesion failure (TLF) and significantly lower rates of target-vessel myocardial infarction (TV-MI). These data reinforce the body of evidence differentiating Orsiro DES from other contemporary DES. Biotronik said Orsiro was the first and only ultrathin strut DES proven to outperform Xience DES.

"The final five-year follow up data confirms Orsiro’s superior safety profile and low TLF rates." said Dr. David Kandzari, US Principal Investigator, Piedmont Heart Institute, Atlanta, GA. "The ultrathin strut Orsiro stent significantly reduces the risk for TV-MI and shows a low rate of stent thrombosis (ST), and specifically a significant reduction in late and very late stent thrombosis. These long-term results confirm that the Orsiro DES sets a new clinical benchmark in PCI treatment options."

Orsiro isn’t the only stenting solution that Biotronik has been in its arsenal. Most notably, Biotronik has the PK Papyrus stent. The firm said the paper-thin stent is one of the key devices in its coronary vascular intervention (CVI) business.