MedAlliance today announced it received FDA investigational device exemption (IDE) approval for its Selution SLR to initiate its coronary pivotal clinical trial for in-stent restenosis. Geneva-based MedAlliance's Selution SLR is a drug-eluting balloon that is indicated for below-the-knee and superficial femoral artery (SFA) indications, for … [Read more...] about MedAlliance’s Selution SLR wins FDA IDE approval for in-stent restenosis
MedAlliance
MedAlliance sirolimus-eluting balloon wins second FDA IDE
MedAlliance this week announced its Selution SLR sirolimus-eluting balloon received conditional FDA investigational device exemption (IDE) approval to begin a clinical trial for occlusive disease of the superficial femoral artery (SFA). The second IDE approval comes a few months after the Geneva, Switzerland-based company won IDE approval for … [Read more...] about MedAlliance sirolimus-eluting balloon wins second FDA IDE
MedAlliance enrolls first patient in drug-eluting balloon trial for erectile dysfunction
MedAlliance announced today that it enrolled the first patient in an erectile dysfunction (ED) feasibility study with its drug-eluting balloon (DEB). Nyon, Switzerland-based MedAlliance’s first patient was enrolled in the trial at the University of Rome Tor Vergata, Italy, under the direction of principal investigator Giuseppe Sangiorgi, a … [Read more...] about MedAlliance enrolls first patient in drug-eluting balloon trial for erectile dysfunction
MedAlliance nabs FDA breakthrough nod for drug-eluting coronary balloon
MedAlliance today said it received FDA breakthrough device designation for its Selution SLR sustained limus release drug-eluting balloon catheter. Selution SLR is designed to treat atherosclerotic lesions in native coronary arteries. The breakthrough designation was awarded for its design of improving luminal diameter in patients with … [Read more...] about MedAlliance nabs FDA breakthrough nod for drug-eluting coronary balloon
