Orsiro1 drug-eluting stent shows long term safety and performance in BIOFLOW trials.- Biotronik.

Biotronik�s Orsiro1 drug-eluting stent (DES) demonstrated high long-term safety and clinical performance according to 60-month follow-up data presented during TCT (Transcatheter Cardiovascular Therapeutics conference) 2017. Data from the BIOFLOW-II randomized controlled trial was presented in a poster session by Dr. Ton Slagboom, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands, showing a target leisure failure (TLF) rate of 10.4 percent in the Orsiro group and 12.7 percent in the Xience study arm at 60 months (p=0.4728). No definite or probable stent thrombosis occurred during 60 months of follow-up in the Orsiro group (n=268). In the Xience group (n=132), one case of very late definite thrombosis was detected (0.7 percent) at five years.

In addition, data from BIOFLOW-III, a prospective, non-randomized, open-label, all-comers registry was presented in a poster session by Dr. Johannes Waltenberger, professor of cardiology and angiology at University Hospital M�nster, Germany. Of an initially enrolled population of 1,356 patients, 898 patients consented for long-term follow up. Among these patients, there was a follow-up compliance of 90 percent at 60 months. The TLF rate of the full cohort was 9.3 percent at 60 months and definite or probable stent thrombosis occurred in eight cases (0.7 percent, including two very late stent thromboses). Long-term data for both trials demonstrate that the previously observed low TLF rates at 12 months persisted through the 60-month follow-up. Rates of definite and probable stent thrombosis remained low through 60 months, affirming the safety of the Orsiro stent system in the long term. The new data presented at TCT 2017 supplements the existing body of evidence supporting the use of the Orsiro DES, with over 32,500 patients enrolled to date in the Orsiro clinical program. This includes the recently reported BIOFLOW-V study data, which showed significantly lower 12-month TLF rates compared to Xience.