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February 12, 2020

Biotronik’s Next-Generation Orsiro Mission DES System Approved in Europe

February 12, 2020—Biotronik has announced CE Mark certification for its Orsiro Mission drug-eluting stent (DES) system. Orsiro Mission, which is the next generation of the company’s ultrathin-strut Orsiro DES, is now available in countries that recognize CE Mark.

In Europe, the Orsiro Mission DES is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease caused by discrete de novo stenotic and in-stent restenotic lesions. Based on the clinical evidence with the company’s Orsiro DES, Orsiro Mission DES has 10 additional indications including acute coronary syndrome, ST-segment elevation myocardial infarction, diabetes mellitus, and complex (B2/C) lesions.

According to Biotronik, the Orsiro Mission DES has a completely re-engineered delivery system to provide enhanced deliverability even in challenging cases. The Orsiro Mission DES provides the benefits of the Orsiro stent while setting the next level of deliverability for acute performance. The device's coating combines passive and active components to avoid interaction with surrounding tissue while ensuring a controlled drug release. The stent’s ultrathin 60-μm struts (≤ 3.0 mm in diameter) reduce blood flow disturbance and support early endothelialization.

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

In the BIOFLOW-V study, the Orsiro DES showed significantly lower rates of target lesion failure and target vessel myocardial infarction at 12 months when compared with a durable polymer everolimus-eluting stent (DP-EES).

In 2017, Biotronik announced data from the BIOFLOW-V randomized trial comparing the Orsiro DES and the Xience DES (Abbott) for the primary endpoint of noninferiority in 12-month target lesion failure (TLF). The results were presented at the European Society of Cardiology’s 2017 congress, held August 26–30 in Barcelona, Spain, and published by David E. Kandzari, MD, et al in The Lancet (2017;390:1843–1852).

The 2-year data from the BIOFLOW-V randomized trial were presented at TCT 2018, the 30th annual Transcatheter Cardiovascular Therapeutics scientific symposium held September 21–25 in San Diego, California. The data were published by David E. Kandzari, MD, et al in Journal of the American College of Cardiology (2018;72:3287–3297).

In addition, newly released data from the BIOSTEMI randomized controlled trial demonstrated superiority of Orsiro over DP-EES with respect to TLF rates at 12 months in patients presenting with ST-segment elevation myocardial infarction. The data were presented by Principal Investigator Juan Fernando Iglesias, MD, at the European Society of Cardiology’s 2019 congress, held August 31–September 4 in Paris, France. The results were published simultaneously in The Lancet (2019;393:1243–1253).

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