MedAlliance Enrolls First Patient in Postmarket Study for Drug-Eluting Balloon
MedAlliance has enrolled the first patient in its large-scale postmarket study of its drug-eluting balloon SELUTION SLR for treating peripheral artery disease (PAD).
The device is a drug-eluting balloon that releases controlled, sustained amounts of sirolimus, an immunosuppressive drug, and is similar to drug-eluting stents. It has received the FDA’s Breakthrough Device designation for PAD below the knee and for treating arteriovenous fistula, and has been given a CE mark for treating PAD.
The single-arm study will span at least 50 sites in Europe, Asia and South America, and will involve patient follow-up at 30 days, six months, then every year for five years.