BIOTRONIK won the European CE Mark for its Orsiro Mission drug-eluting stent. The device is intended for widening coronary arteries at sites of stenotic and in-stent restenotic lesions, and is designed to be delivered through some of the more tortuous vasculature.
The device is the next generation of the Orsiro drug-eluting stent and the redesign comes with ten additional indications, such as acute coronary syndrome (ACS), ST Elevation Myocardial Infarction (STEMI), diabetes mellitus and complex (B2/C) lesions
The “ultrathin” struts are only 60 μm (≤3.0 mm) in diameter, helping the stent to blend in with the surrounding vessel tissue, causing less turbulence, and allowing healthy new tissue to regrow. After the stent is placed, its coating releases an anti-proliferative medication to prevent restenosis.
“The Orsiro Mission stent system performed smoothly under critical conditions in highly complex interventions,” stated Dr. Mathias Brandt, University Hospital in Salzburg, Austria, in a BIOTRONIK press release. “After having used a significant amount of this newest generation stent, this is my first choice for even the most challenging lesions.”
Some clinical data, according to BIOTRONIK:
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 with a 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 TLF rates at 12 months in patients presenting with ST-segment elevation myocardial infarction (STEMI).
Flashbacks: BIOTRONIK’s Orsiro Ultrathin Coronary Stent Approved in U.S.; BIOTRONIK’s Orsiro Hybrid DES Performs Well in Human Trial; Orsiro Stent with Hybrid Drug-Eluting Coating Now Available in France;