Biotronik Has a New DES Added to its Repertoire
FDA has just signed off on Biotronikâs Orsiro drug-eluting stent (System). The Lake Oswego, OR-based company claims the stent is the first and ultrathin DES to outperform Abbott Laboratoriesâ, Xience stent, which is known as the clinical standard.
Biotronik said its first implants will occur this week and that it will be available in health systems in the early part of this year. The company has had CE mark for Orsiro since 2011.
Perhaps the biggest selling point of the technology is the ultrathin strut design.
âThinner struts are different in that they potentially create less disruptive flow in the arteries,â Amy Culley, Biotronik Director of VI Clinical Studies, told MD+DI. âThat equates to less internal injury and improved endothelialization. This is important in reducing the risk of restenosis and thrombosis, both outcomes that we want to avoid in our patient population.â
Orsiro and Xienceâs effectiveness were compared in the BIOFLOW-V pivotal trial. Biotronikâs Orsiro stent demonstrated significantly lower rates for target lesion failure and target vessel myocardial infarction at 12 months in comparison to Xience. The study looked at about 1,344 patients.
At two years, treatment with Orsiro further improved event rates in comparison to Xience, including a significant reduction in target lesion revascularization (TLR) and spontane...
Source: MDDI - Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news
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