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.
M.A. MedAlliance SA, a company developing and commercializing the first sirolimus micro-reservoir drug-coated balloon (SELUTION™ DCB) to treat patients suffering from peripheral artery disease (PAD), coronary artery disease (CAD), arteriovenous fistulas (AVF) and grafts (AVG) for end-stage renal disease, has raised $37 million.
The First-in-Man (FIM) study of SELUTION™, Med Alliance’s novel sirolimuscoated balloon, was presented today in a Late-Breaking Trials session at the CRT meeting in Washington DC by Principal Investigator Professor Thomas Zeller, Universitaets-Herzzentrum, Bad Krozingen, Germany. It demonstrated safety and efficacy in long lesions.
Primary endpoint data from the First-in-Man (FIM) study of SELUTION™, Med Alliance’s novel sirolimus-coated balloon, was presented today at the Leipzig Interventional Course (LINC) by Principal Investigator Professor Thomas Zeller, Universitaets-Herzzentrum, Bad Krozingen, Germany.
Swiss-based medical technology company Med Alliance has announced a strategic agreement with Kaneka Corporation, Japan’s leading provider of PTCA balloons. The agreement involves technical collaboration, product licensing, manufacturing and distribution for the Med Alliance sirolimus Drug-Coated Balloon (DCB) in Japan for the treatment of coronary arteries.