www.fdanews.com/articles/197695-medalliance-earns-ce-mark-for-drug-eluting-balloon
MedAlliance Earns CE Mark for Drug-Eluting Balloon
June 19, 2020
MedAlliance has received CE mark certification for its Selution SLR 014 PTCA, a sirolimus drug-eluting balloon for treating patients with coronary arterial disease.
Sirolimus is an immunosuppressive drug frequently used to prevent organ rejection after a kidney transplant. The new certification is for treatment of lesions and in-stent restenosis.
The drug-eluting balloon uses “micro reservoirs” composed of biodegradable polymer that is mixed with the drug to control its release.