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Until now more then 60 patients were successfully operated using B.Y.Fix devices. We have demonstrated its safety and efficacy for treatment of Abdominal Aortic Aneurysms (AAA), Aorto-Iliac Aneurysms (AIA), Aortic Occlusions and above the knee arterial occlusions.
The surgeries were conducted in Germany, Italy, Poland, Israel and Russia and 50 of the operated patients have already completed one-year of follow up.
The average time for anastomosis creation in open surgery using our device was 5.5 minutes and its quality was confirmed during 12 months of follow up. There were no leakages or migrations of the devices observed and the recovery time of patients decreased.
Prior to clinical trials, the successful preclinical studies for both open and laparoscopic applications were completed including in-vivo animal, MRI safery, in-vitro, test-bench and cadaver studies.