Las Vegas, 5 November 2019 – Two-year data from the First-in-Human study of SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, was presented today at VIVA 2019 by Principal Investigator Professor Thomas Zeller, Universitaets-Herzzentrum, Bad Krozingen, Germany. The study involved 50 patients treated with the investigational device in lesions of the superficial femoral artery (SFA) and popliteal artery.
MedAlliance Receives FDA Breakthrough Device Designation Status for Sirolimus Drug-Eluting Balloon to Treat Below-the-Knee Disease
MedAlliance, the first drug-eluting balloon company in the world to receive US Food and Drug Administration (FDA) Breakthrough Device Designation Status for the treatment of coronary ISR, has been awarded similar status for SELUTION SLR™, its sustained limus release drug-eluting balloon (DEB) catheter, for the treatment of Below-the-Knee Disease.
Swiss-based M.A. MedAlliance SA has been granted Breakthrough Device Designation from the US Food and Drug Administration (FDA) for SELUTION™, its sustained limus release (SLR) drug-eluting balloon (DEB) catheter, for the treatment of coronary disease.