BIOTRONIK Introduces Next Generation Drug-Eluting Stent System in the CE Region
Orsiro Mission Provides the Next Level of Deliverability for the Orsiro Stent
BIOTRONIK has announced CE Mark certification for the Orsiro® Mission drug-eluting stent (DES) system. The next generation of the company’s ultrathin strut Orsiro DES provides higher deliverability than other contemporary stents.1 Orsiro Mission is now available in CE Mark countries.
The Orsiro Mission DES has a completely reengineered delivery system to support interventionalists with outstanding deliverability even in challenging cases. “The Orsiro Mission stent system performed smoothly under critical conditions in highly complex interventions,” stated Dr. Mathias Brandt, University Hospital in Salzburg, Austria. “After having used a significant amount of this newest generation stent, this is my first choice for even the most challenging lesions.”
Setting the next level of deliverability for acute performance, the Orsiro Mission DES provides the benefits of the Orsiro stent. The 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 (≤3.0mm in diameter) reduce blood flow disturbance and support early endothelialization.2
The Orsiro Mission DES is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo stenotic and in-stent restenotic lesions. Based on the extensive clinical evidence with Orsiro DES*, Orsiro Mission DES has ten additional indications** including acute coronary syndrome (ACS), ST Elevation Myocardial Infarction (STEMI), diabetes mellitus and complex (B2/C) lesions.
With Orsiro’s clinical program clinicians can be sure when they choose the Orsiro Mission DES they are choosing an implant with extensive evidence.* Safety, efficacy and clinical performance of the Orsiro stent has been investigated in clinical studies with more than 48,500 patients enrolled to date.3 Significantly lower rates of target lesion failure (TLF) and target vessel myocardial infarction (TV-MI) were observed at 12 months in comparison to a DP-EES*** in the BIOFLOW-V study.4 In addition, according to newly released data from the BIOSTEMI trial, Orsiro has demonstrated superiority over DP-EES with respect to TLF rates at 12 months in patients presenting withST-segment elevation myocardial infarction (STEMI).5
“Orsiro Mission combines the best of two worlds – the outstanding Orsiro stent and the next level of deliverability,” said Dr. Alexander Uhl, President 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.”
1 In comparison to Xience Sierra, Resolute Onyx and Synergy for bench tests on pushability, trackability and crossability. BIOTRONIK data on file.
2 Foin et al. Impact of stent strut design in metallic stents and biodegradable scaffolds. Int J Cardiol.2014 Dec 20;177(3):800-8.
3 Status: January 2019.
4 Kandzari D et al. Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents versus Thin Durable Polymer Everolimus-Eluting Stents in Patients Undergoing Coronary Revascularisation (BIOFLOW-V): a randomized trial, 2017, The Lancet. 2017.
5 Iglesias JF et al. Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (BIOSTEMI): a single-blind, prospective, randomised superiority trial. The Lancet. Published online: September 2, 2019. DOI: https://doi.org/10.1016/S0140-6736(19)31877-X
*Clinical data conducted with Orsiro, Orsiro Mission’s predecessor device can be used to illustrate Orsiro Mission clinical outcomes.
**For all indications please see Instruction for Use.
***Durable Polymer Everolimus Eluting Stent
Orsiro and Orsiro Mission are trademarks or registered trademarks of the BIOTRONIK Group of Companies. All other trademarks are the property of their respective owners.
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.