The First-in-Man (FIM) study of SELUTION™, Med Alliance’s novel sirolimus-coated balloon has been presented today in a Late-Breaking Trials session at the CRT meeting in Washington DC.
Med Alliance is a privately-owned medical technology company headquartered in Switzerland, with an R&D facility in Irvine, California.
Med Alliance’s SELUTION Drug Coated Balloon (DCB) contains micro-reservoirs made from biodegradable polymer intermixed with the antirestenotic drug sirolimus. The micro-reservoirs, which are unique to SELUTION, facilitate controlled and sustained release of sirolimus, which provides a therapeutic effect in treating lesions over a prolonged period. It demonstrated safety and efficacy in long lesions.
The ground-breaking study has demonstrated that SELUTION is the first DCB with sustained release of sirolimus to be effective in the treatment of both superficial femoral artery and popliteal artery lesions.
“These results from the SELUTION FIM study are promising”, commented Principal Investigator Professor Thomas Zeller, Universitaets-Herzzentrum, Bad Krozingen, Germany.
“The findings confirm the efficacy of the SELUTION sirolimus-coated technology and they concur with previous paclitaxel drug-coated balloon studies in the superficial femoral artery. The primary endpoint has been achieved, and excellent clinical outcomes have been reported: Rutherford Classification, Ankle-Brachial-Index, Walking Impairment and Quality-of-Life assessment have all indicated beneficial patient improvement from this sirolimus technology. The early insight that patients with long lesions have similar efficacy when treated with the SELUTION Sirolimus DEB is very encouraging.”
“We are very pleased with these results”, added Med Alliance Chairman Jeffrey B. Jump. “this data gives us confidence to expand into other therapeutic areas, both further down in peripherals and into the coronary arteries. We will also aggressively pursue regulatory approval in the US, Japan and China so that patients around the world can benefit from this exciting new technology.”
Source: Med Alliance