Orsiro Mission gets CE mark

Orsiro Mission DES
Orsiro Mission DES system

Biotronik has received CE mark certification for the Orsiro Mission drug-eluting stent (DES) system. According to a company statement, the next generation of the ultrathin strut Orsiro DES provides higher deliverability than other contemporary stents. Orsiro Mission is now available in CE mark countries.

The press release outlines that the Orsiro Mission DES has a completely reengineered delivery system to support interventionalists with outstanding deliverability, even in challenging cases. The coating combines passive and active components to avoid interaction with surrounding tissue, while ensuring a controlled drug release. The stent’s ultrathin 60μm struts (≤3mm in diameter) reduce blood flow disturbance and support early endothelialisation.

The Orsiro Mission DES is indicated for improving coronary luminal diameter in patients with symptomatic ischaemic heart disease due to discrete de‑novo stenotic and in-stent restenotic lesions. The press release outlines that, based on the extensive clinical evidence with Orsiro DES, Orsiro Mission DES has 10 additional indications, including acute coronary syndrome (ACS), ST-elevation myocardial infarction (STEMI), diabetes mellitus, and complex (B2/C) lesions.

“The Orsiro Mission stent system performed smoothly under critical conditions in highly complex interventions,” states Mathias Brandt (University Hospital Salzburg, Austria). “After having used a significant amount of this newest-generation stent, this is my first choice for even the most challenging lesions.”

The press release details that safety, efficacy and clinical performance of the Orsiro stent has been investigated in clinical studies, with more than 48,500 patients enrolled to date. Significantly lower rates of target lesion failure (TLF) and target vessel myocardial infarction (TV-MI) were observed at 12 months in comparison to a durable polymer everolimus-eluting stent (DP-EES) in the BIOFLOW-V study. In addition, according to newly released data from the BIOSTEMI trial, Orsiro has demonstrated superiority over DP-EES with respect to target lesion failure (TLF) rates at 12 months in patients presenting with STEMI.

“Orsiro Mission combines the best of two worlds—the outstanding Orsiro stent and the next level of deliverability,” says Alexander Uhl, president of Vascular Intervention at Biotronik. “With more than 700 ‘real world’ evaluations successfully completed so far, Orsiro Mission is another example of how our products can make a difference in today’s patient care. By continuously improving the performance of our products, we support physicians in achieving outstanding patient outcomes.”


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