Swiss medical technology company MedAlliance has secured breakthrough device status from the US Food and Drug Administration (FDA) for its SELUTION SLR drug-eluting balloon (DEB).
SELUTION SLR is a sustained limus release DEB catheter designed for the treatment of atherosclerotic lesions in native coronary arteries.
MedAlliance stated that this is the fourth breakthrough designation provided to the company for its sirolimus DEB following coronary in-stent restenosis, peripheral below-the-knee and AV-Fistula indications.
The breakthrough status granted by the FDA for the SELUTION SLR 014 is for enhancing luminal diameter in patients with atherosclerotic lesions in native coronaries.
MedAlliance chairman and CEO Jeffrey Jump said: “MedAlliance is honoured to have our sirolimus DEB selected for the FDA’s Breakthrough Device Program for a fourth time.
“This may provide US patients faster access to our novel 90 day sustained sirolimus release technology, with the potential to provide safer and more effective treatment.
“This Designation, combined with the previous coronary ISR Breakthrough Designation, will give US cardiologists exciting new tools to fight coronary disease.”
The technology of SELUTION SLR consists of advanced microreservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus.
The microreservoirs facilitate the controlled and sustained release of the drug. Extended release of sirolimus from stents has been demonstrated efficacious in both coronary and peripheral vasculatures, said the company.
MedAlliance’s advanced CAT (cell adherent technology) allows the microreservoirs to be coated onto balloons and stick to the vessel lumen when delivered through an angioplasty balloon.
In June last year, the company secured the CE Mark approval for its SELUTION SLR 014 PTCA to treat coronary arterial disease.
