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.